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Moderator: Irene Aihie

January 21, 2016

12:00 pm CT

Coordinator: Welcome and thank you for standing by. At this time, all participants are in a 

listen-only mode. After the presentation, we will conduct a question and 

answer session. If you would like to ask a question, you may press star 1.

Today's conference is being recorded. If you have any objections, you may 

disconnect at this time. Your host for today's conference is Ms. Irene Aihie.

Thank you. You may begin.

Irene Aihie: Hello and welcome to today's FDA webinar. I am Irene Aihie, of CDRH's 

Office of Communication and Education. On December 9, 2015, the U.S. 

Food and Drug Administration issued the final version of the guidance 

document, Premarket Notification Requirements Concerning Gowns Intended 

for Use in Health Care Settings.

This guidance clarifies and describes the premarket regulatory requirements 

for gowns regulated under 21 CFR 878.4040, and the performance testing 

needed to support liquid barrier claims for gowns intended for use in health 

care settings.
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The focus of today's Webinar is to review the document and help 

manufacturers and other interested stakeholders understand information 

provided in the final guidance. Your presenters are Terrell Cunningham and 

Lauren Lilly, both scientific reviewers from the Office of Device Evaluation.

Following the presentation, we will open the lines for your questions related 

to topics in the guidance only. Additionally, there are other Centers' subject 

matter experts available to assist with the Q&A portion of our Webinar. Now, 

I give you Terrell.

Terrell Cunningham: Good afternoon. I would also like to also add my thank you to all of those 

who have joined us for today's discussion. I am Terrell Cunningham, team 

lead for personal protective equipment in the Infection Control Branch.

Today we’re going to discuss the recently published guidance document, 

Premarket Notification Requirements Concerning Gowns Intended for Use in 

Health Care, and FDA's regulations of surgical gowns.

Different types of gowns are used in various health care settings to prevent the 

transmission of infection and illness. This guidance clarifies the premarket 

regulatory requirements and performance testing needed to support liquid 

barrier claims for these gowns.

For the purpose of today's discussion, the term surgical gown will be used to 

refer to the gowns that are intended for use in health care. Today's discussion 

will start with a review of the scope of the guidance document and device 

clarification.
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Next up, Lauren Lilly will provide an overview of FDA's premarket review of 

gowns and the recommended performance testing, labeling requirements, and 

we will conclude with the FDA's expectations of gown manufacturers.

It is important to ensure health care workers and patients are adequately 

protected and informed about their protective equipment. Hopefully, this 

information presented today, will reinforce current knowledge that you have 

about FDA review of surgical gowns.

The scope of this document is limited to gowns making liquid barrier 

protection claims and intended for use in health care settings. For the purpose 

of this guidance, the term "minimal" or "low barrier protection" refers to 

ANSI Level 1 and Level 2 protection or equivalent levels of protection.

The terms "moderate" or "high barrier protection" refers to PB70 Level 3 and 

Level 4 protection. Please note that this guidance does not address the data 

needed to support gowns making claims of provided protection against 

specific organisms, chemical agents, chemotherapy drugs, or those gowns that 

are labeled to provide specific disease prevention claims such as “protects 

against Ebola”.

Manufacturers desiring to make and to market their gowns with these types of 

claims or design features are encouraged to utilize the pre- submission process 

to obtain guidance from the Agency prior to submission of a 510(k).

Surgical gowns are classified under the surgical apparel regulation. Surgical 

apparel by definition are intended to be worn to protect both the patient and 

the health care worker from transfer of microorganisms, body fluids, and 

particulate matter.
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Surgical apparel includes surgical caps, hoods, masks, gowns, operating room 

shoes and shoe covers, isolation masks, and isolation gowns. The primary 

function of a surgical gown is to act as a barrier.

All surgical gowns are Class 2 devices, subject to special control, and require 

510(k) clearance by FDA. Surgical apparel other than surgical gowns and 

surgical masks are Class 1. Class 1 devices are subject to general controls, and 

are exempt from premarket notification procedures.

In determining whether a gown is intended for use as a surgical gown under 

the surgical apparel regulation, FDA considers the terminology used, the level 

of barrier protection claimed, and the device's technological characteristics.

A gown is a Class 1 exempt and not a “surgical gown” if all of the following 

factors apply: It is labeled as a gown other than a surgical gown, for example, 

an isolation gown. It is not described in its labeling as a surgical gown, and it 

has a statement relating to barrier protection, such as claims of minimal, low, 

or no barrier protection.

If all of the above factors apply, the gown is considered Class 1 exempt from 

premarket notification, or, simply put; no 510(k) is required. The device is a 

Class 1 exempt because general controls are sufficient to provide reasonable 

assurance of safety and effectiveness of the device.

For purposes of determining classification of a gown under the surgical 

apparel regulation of gowns falling within this regulation, is a surgical gown if 

any of the following apply: It is labeled as such, using terminology such as 

surgical gowns or surgical isolation gowns. It is described as such in its 

labeling. "This gown is suitable as a surgical gown."
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It has the statement related to moderate or high level barrier protection, PB70 

Level 3 or 4 barrier claims, or claims of impervious, prevents strikethrough, 

bullet proof, or impermeable. And, it has a statement, that it is intended for 

use during sterile procedures. That it also includes sterile isolation gowns or 

gowns distributed in sterile packages.

FDA considers gowns that claim moderate to high level barrier protection to 

be a higher risk than those that claim minimum or low level of barrier 

protection. All gowns with Level 3 and Level 4 barrier claims are considered 

Class 2 devices, under the surgical apparel regulation and are subject to 

premarket review.

All Class 2 gowns are subject to premarket review. This includes surgical 

gowns and surgical isolation gowns. Isolation gowns are Class 1. However, 

they become Class 2 if additional claims are made, such as moderate or high 

barrier functions, or claims associated with PB70 Level 3 or Level 4.

These gowns are defined as surgical isolation gowns, and should be reviewed 

by FDA. Isolation gowns with barrier function claims are defined, again, as 

surgical isolation gowns.

Lauren Lilly: Hello. My name is Lauren Lilly, and I'd like to give an overview of what 

information FDA expects or recommends be provided when submitting a 

510(k) for surgical gowns.

Most of the information I will mention today can be found in our two 

guidance documents relating to gowns, the 1993 guidance document for 

Premarket Notification Submissions for Surgical Gowns and Drapes, as well 

as the guidance document published most recently, which is a supplement to 

the 1993 guidance.
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We also recommend that sponsors look at guidance documents relating to the 

510(k) process, and what general information is recommended when 

submitting a 510(k).

Most of the guidance documents referenced in this talk will be included at the 

end of this presentation. 

When it comes to review of gowns with moderate or high barrier claims, 

information regarding performance and safety testing conducted should be 

submitted. For liquid barrier testing, FDA recommends the use of FDA 

recognized standard, ANSI/AAMI PB70. Depending on the level of barrier 

protection claimed, water impact penetration, hydrostatic pressure resistance, 

and resistance to viral penetration are testing methods recommended by the 

standard.

In addition to barrier integrity testing, safety is also an important aspect and 

sponsors are expected to provide data demonstrating that the device is safe for 

use. We will look more closely at FDA expectations and recommendations

regarding premarket notifications in the upcoming slides.

Representative engineering drawings should be included with your submission 

with the critical and non-critical zones identified. Any special features should 

also be depicted. 

Sample labeling should also be submitted. The provided labeling should 

clearly identify the level of liquid barrier protection claimed. Prior to the 

existence of ANSI/AAMI PB70, moderate or high barrier protection claims 

included, but were not limited to, wording such as prevents strikethrough; 
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high fluid protection; impervious; fluid-proof; fluid-resistant; highest level of 

protection; and impermeable.

Because of the lack of specificity with respect to performance characteristics 

and test methods, FDA now discourages the use of such language, and no 

longer clears products with such labeling claims.

Instead, manufacturers are encouraged to specify the level of liquid barrier 

protection as per ANSI/AAMI PB70 on all labeling. Labeling should also 

include the directions for use, the indications for use and, if applicable, 

validated reprocessing instructions.

For gowns making moderate to high barrier claims, sponsors are expected to 

provide data to support claims when sending a premarket notification. 

Therefore, sponsors should provide evidence that the gown complies with the 

claimed level of liquid barrier protection as according to ANSI/AAMI PB70 

or an equivalent test method.

Copies of performance testing should be provided for FDA review. This 

information is necessary to support barrier performance claims. FDA 

recommends that adequate, statistically significant sample size is used.

Generally, we recommend a sample size of approximately 32 gowns. Liquid 

barrier testing should be done on all critical zones and non-critical zones, 

including the back of the gown.

FDA also recommends that performance at the seams of the gown should also 

be tested. Please note that for surgical isolation gowns, that is, isolation gowns 

with moderate to high liquid barrier level claims, the critical zone 

encompasses the entire gown.
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For surgical gowns intended for use in the operating room, the critical zone is 

defined as the front mid-chest area to the upper knees, as well as the lower 

arms. The non-critical zones of surgical gowns can have any protection level 

from 1 to 4. Additionally, the back of the surgical gown may be nonprotected, according to PB70, but must be specifically labeled as such. 

In addition to providing performance data, a clear description of the device 

design, including all models, dimensions and manufacturing specifications 

and tolerances, should be stated for each device design.

Additionally, all materials including adhesives and dyes should be specified. 

Representative engineering drawings should be included with your 

submission, and the critical/non-critical zones as well as the seams should be 

identified.

Additionally, sample labeling should clearly identify the level of the liquid 

barrier protection as per ANSI/AAMI PB70. As mentioned previously, claims 

such as prevents strikethrough, highest fluid protection; impervious; fluidproof; fluid resistant; highest level protection; and impermeable are no longer 

cleared by FDA.

Please be sure to include sample labeling that also includes the directions for 

use and indications for use. When submitting a 510(k), all components for the 

device should be listed and the use life for each component of the device 

should be identified. Therefore, manufacturers are expected to state if the 

gown or any part of the gown is intended for single use, single patient use, or 

multiple patient use. 

Under the 510(k) program, substantial equivalence is evaluated. Therefore, a 

comparison table between the subject and predicate device is expected. The 
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comparison table should include a comparison of the indications for use, the 

materials used in constructing the devices, sterilizations methods, and 

importantly, the PB70 level of the subject and predicate device.

Additionally, sterilization according to the K90 guidance document issued by 

FDA should also be included; particularly the sterilization method, validation 

method and packaging information should be included. If the device is also 

intended to be sterilized by re-packagers, sterilization instructions according 

to the referenced sterilization method should be included. 

While a shelf life claim is not required at this time for gowns, single use and 

reusable gowns with shelf life claims should be supported by testing 

performance at the end of shelf life.

To support a shelf life claim, it is FDA's expectation that performance testing 

at the end of shelf life demonstrates that aging does not adversely affect the 

performance of the gown. FDA recommends that at minimum, sponsors 

should assess the liquid barrier performance of the device at the end of the 

claimed shelf life. 

If the device or gown is intended to be reusable, in addition to demonstrating 

the barrier performance at the end of shelf life, the performance of the gown at 

the end of the maximum reprocessing cycles should also be demonstrated.

The reprocessing protocol used to assess the liquid barrier performance at the 

end of the labeled use life, should be similar to the reprocessing instructions 

included in the labeling. The maximum number of reprocessing cycles should 

also be stated on the labeling.
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Presented on this slide are the four performance levels according to 

ANSI/AAMI PB70. The level of gown obtained is determined by its ability to 

resist fluid penetration under the conditions described in the table presented 

on this page.

Level 1 and Level 2 liquid barrier performance claims are considered minimal 

or low levels of performance. Conversely, Level 3 and Level 4 are considered 

to provide moderate or high levels of protection.

To reiterate, isolation gowns making moderate or high level liquid barrier 

claims are defined as surgical isolation gowns, and should be reviewed by 

FDA. For Level 3 gowns, please note that according to PB70, both AATCC 

42 impact penetration testing and AATCC 127 hydrostatic water pressure 

testing should be performed.

We also advise that the sampling plan recommend by ANSI/AAMI PB70, that 

is an AQL of 4% with an alpha of .05 and an RQL of 20% with a beta of .1, is 

followed. 

In addition to barrier performance testing, it is recommended that sponsors 

also assess the physical and mechanical properties of gowns. It is FDA's 

expectation that gowns should have the physical strength to resist tears and 

punctures. Secondly, the gowns should be comfortable to wear. As such, we 

would recommend that non-barrier property testing, such as grab tensile 

strength, snag resistance, linting, heat loss and water vapor transmission, be 

performed.

Data from flammability testing according to 16 CFR Part 1610, should also be 

documented within the submission. If the device is a surgical gown, and 
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therefore required to be sterile, the sterilization method and validation should 

be stated.

Again, if the device is labeled reusable, either as a single patient reusable or 

multiple patient reusable, laundry instructions should be described. The 

maximum number of uses, as well as the method used in order to track the 

number of uses, should be stated and presented in the labeling.

Lastly, in addition to physical and mechanical related testing, the device 

should be demonstrated to be safe for use. Biocompatibility is an important 

safety aspect for gowns, and therefore needs to be assessed. FDA recommends 

the use of ISO 10993 Part 10 for skin contacting devices and that skin 

irritation and sensitization should be assessed.

Terrell Cunningham: Hello. I'm Terrell Cunningham again, and I will conclude today's 

discussion with FDA expectations on what we expect from manufacturers.

Manufacturers intending to market or those currently marketing Class 2 

gowns as described in this guidance, should accomplish the following.

One, submit a 510(k) for the gown to the agency within 60 days of the 

publication of the final guidance. The due date for this will be February the 

7th, 2016. Number 2: Have a 510(k) submission for the gown accepted by the 

agency for review within 75 days of the publication of the final guidance. The 

due date for the 75 day publication is February 26, 2016. Thirdly, obtain a 

510(k) clearance for the gown within 180 days from the publication of the 

final guidance. This will be due June 6, 2016. FDA intends to work 

interactively with manufacturers as appropriate during the review process.

If a manufacturer has completed steps one and two above but has not received 

clearance of this device within the 180 days because the submission remains 
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under active review, the manufacturer should contact FDA to discuss whether 

the agency intends to continue to defer enforcement under these 

circumstances.

FDA recommends that surgical gowns cleared for marketing need the minimal 

performance specifications provided in the guidances that are listed on the 

slide above. These documents may be found at the Web sites that are listed.

Other relevant FDA guidances are listed on the next two slides. FDA 

recognized consistent standards facilitate the premarket review process. FDA 

recognized standards for surgical gowns are listed on the next two slides.

The use of these standards produce voluntary consensus among industry, 

health care device users and FDA. The standards provide defined qualification 

criteria for the device quality assurance. Consensus standards are updated as 

technology and experiences advance. This concludes our portion of the 

presentation, and we're now ready to accept questions.

Coordinator: Thank you. At this time, we will now be the question and answer session. To 

ask a question, please press star 1. You will be prompted to record your first 

and last name.

To withdraw your request, press star 2. Once again, press star 1 to ask a 

question. Please stand by for our first question. Our first question comes from 

(Mark Craymars). Your line is now open.

(Mark Craymars): Thank you and we appreciate the opportunity to get some clarification. I just 

wanted to find out, if I label my gown for sterile use in compounding 

pharmacies, does the surgical guidance apply to this?
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Terrell Cunningham: (Mark), this is Terrell Cunningham. If I understand your question correct, 

would there be any patient contact? What is the intended use of that use of 

that function?

(Mark Craymars): No patient contact whatsoever. It's for mixing solutions in a compounding 

pharmacy.

Terrell Cunningham: My initial response is that that may fall more of an occupational use, and 

not necessarily a health care function, which was the intent of our guidance 

document. But to just be on the safe side, I would recommend that you would 

email that question or this would afford us an opportunity research it, and we 

will give you formal feedback via email. And thank you for the question.

(Mark Craymars): Could I get that email address, or is that just fda.gov?

Terrell Cunningham: It will be the email address that's posted on the slide.

(Mark Craymars): Excellent. Okay, I appreciate the initial reply, and we'll put it in writing for 

further guidance.

Terrell Cunningham: Thank you.

(Mark Craymars): Thank you.

Coordinator: Our next question comes from (Daniel Gluxom). You may ask your question.

(Daniel Gluxom): Hi, and thank you for taking the question. You mentioned, Mr. Cunningham, 

you mentioned some dates like February 7. Is that the expected date of the 

publication of the final guidance?
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Terrell Cunningham: The actual guidance document that we are discussing today was published 

on December the 9th, 2015.

(Daniel Gluxom): Okay.

Terrell Cunningham: Based on that guidance document, there were several dates that were 

crucial. There was the 60 date, 75 and 180. And if you look at that slide, it 

will actually clarify on which date, what was expected.

(Daniel Gluxom): All right. Thanks.

Coordinator: Our next question comes from (Mike Shola). You may ask your question.

(Mike Shola): Hello Terrell. It's (Mike). How are you?

Terrell Cunningham: Doing well, (Mike). How are you?

(Mike Shola): Good. I have a question for you. So the guidance document says "or 

equivalent" to AAMI PB70. But AAMI PB70 also not only describes barrier 

performance, it also describes an AQL Level. So, I want to make sure that I 

understand that, if you make a claim to barrier resistance without an AQL 

Level, it's not equivalent, right?

Terrell Cunningham: Restate your question again, please.

(Mike Shola): So, AAMI PB70 describes four levels of protection. It also describes an AQL 

Level. If you make claims in your, in the guidance document, the document 

that was published in December, it says, "or equivalent". So, I'm asking the 

question, if you make the claims of meeting ASTM 1671, but no claims 

around an AQL, is that equivalent?
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Terrell Cunningham: I would not interpret that as being equivalent, because you have failed to 

provide evidence that your product meets the pass/fail criteria as stated within 

the standard. When we use the term...

(Mike Shola): No, no. I want to make sure. This is a very pertinent point. In AAMI PB70 

describes a quality level and people describe a compliance with standards, 

without AQL, and I want to make sure that I understand the fact that, if you 

don't describe an AQL, it's not equivalent. Because your guidance document 

says, all over the place, equivalent.

(Erin Keith): Hi. My name is (Erin Keith). I'm the division director that houses, for the 

division that houses INCB. What I wanted to make clear to you is about, in 

the language that you're talking about is, the ANCM standard is a voluntary 

standard. And we do not require voluntary standards as law.

But what we say is that you can provide alternative testing, at times in general 

circumstances, and the guidance is trying to leave open the window for 

circumstances where someone would provide equivalent methodology to that 

standard, but not yet meet that specific standard.

So, as Terrell was saying, we would, because the standard itself addresses the 

AQL Level, we would expect the equivalent alternative testing that was, that's 

been submitted or suggested is equivalent to redress those issues and explain 

why they are equivalent.

(Mike Shola): Okay, so I have one more question. What differentiates a gown from a 

coverall?
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Terrell Cunningham: This is Terrell. I will attempt to provide a response. When you look at the 

actual title of our guidance document, it's focused on gowns intended for use 

in health care settings. While we definitely use the term gown, the actual 

publication is concerned that there are other products.

And we've talked about the terminologies that have been used in describing 

some of the other products, as being cover gowns, procedure gowns. And 

whereas the actual name that you call that product is not as important as what 

is the intended use of the product. What is the function? What are the claims?

So, when we look at our guidance document, I think we have to really read the 

guidance document and seek to understand what the agency's concerns are.

The concerns are that you have a product that's being promoted for use in the 

health care setting that hasn't been proven or cleared by the agency.

And we're concerned with the uses and the functions of that product. So that's 

a question I think that we could entertain offline. It's a very direct question

and it's an important question.

But I believe we stated - and I don't know if you recall that at some of the 

PB70 meetings that we can continue that discussion that when you have a 

coverall and you're actually making disease prevention claims, you have 

tripped the exemption of that device and you've brought it into medical device 

land.

(Mike Shola): All right. Thank you very much.

Coordinator: Our next question comes from (Hannah Shohan). Your line is now open.
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(Winging): Hello. This is (Winging) from Medtronic. Thank you so much for the 

overview and the guidance document. So my question is in regards to Page 8 

of the guidance.

For what is in scope of a Class 2 surgical gowns? So there are four bullet 

points that are listed. And my interpretation of that, and I want confirmation, 

is if any one of those applies, not all four. Is that correct?

Terrell Cunningham: It's - it would just so happen I don't have Page 8. But I do recall our 

discussion. And it - for the purpose of determining classification if - all of 

those apply.

(Winging): Okay. And I think this goes to the previous questions that were asked so it's 

almost like I'm...

Terrell Cunningham: No. It's just - if you could let me just clarify that. It's not all, it's any of 

those or. (Lawrence), are you going to speak to it? There's an “or. If labeled as 

such, if it's described.

And it's labeled as such, if it has a statement relating to moderate or high 

levels barrier protection. Or, if there is a statement that is intended for use 

during sterile procedure. So if any of those apply it would be considered a 

Class 2 gown.

(Winging): Okay. Thank you for that clarification. I have a follow up question to that. So 

the third bullet says if it has a statement relating to moderate or high level 

barrier protection.

And in the last question that you answered, you talked about this guidance 

documents being applicable to the health care setting. So, if there were, kind 
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of, a nonsurgical application for a specific gown that was used in the health 

care setting for let's say, mixing personal protective equipment for mixing 

caustic drugs.

Or other types of chemicals, but it was still in the health care setting, is that, 

would that put those products within the scope of Class 2 surgical gowns if it 

had the statement of moderate to high level barrier protection?

Terrell Cunningham: Yes, it would. And if you recall there was one of the slides, I don't have 

the number, that actually addressed some of the intended uses that went 

beyond the scope that we recommend that you use the pre-submission process 

to obtain greater or more information.

We are concerned with gowns that are labeled to provide protection against 

chemical agents or chemo therapy agents. There is an expectation that you 

have actual performance test data that demonstrate that performance and that 

that product be labeled accordingly. So I would encourage you to use an 

avenue for follow up discussion as it relates to that.

(Winging): Great. Thank you very much.

Coordinator: Our next question comes from (Earla Clark). Your line is now open.

(Earla Clark): Yes. Thank you so much for your presentation today. My question has to do 

with understanding whether you have guidance available for hospital 

equipment vendors.

On the correct gowns or coveralls for engineering where when servicing 

equipment in the hospital oncology compounding area. I've read a number of 
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comments that the most defective and protective gowns are the ones that are 

the hottest.

They don't dissipate heats, moisture. So, it sounds as though that's not what's 

covered here today, but I'm wondering if you have alternate guidance 

available somewhere?

Terrell Cunningham: Well, I thank you for the question, but at the point I am not knowledgeable 

on any such guidance as it relates to that product. But we would encourage 

you to forward your question to our - the address on the slide and we will give 

you a follow up response to that.

(Earla Clark): Thank you so much.

Terrell Cunningham: Thank you.

Coordinator: Our next question comes from (Caroline Netelli). You may ask your question.

(Caroline Netelli): Hi. This is (Caroline Netelli) from Cardinal Health. We have a couple 

questions for you and we appreciate this presentation today. It's been very 

helpful. The first question that we have is, will the FDA accept submissions 

for surgical isolation gowns that do not include an AAMI rating assignment to 

the gowns?

Terrell Cunningham: Repeat that question, please? Just for clarity, let me just repeat it to tell me 

if I understood it correctly.

(Caroline Netelli): Okay.
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Terrell Cunningham: Am I understanding you correct in - your intent is to submit a 510(k) for a 

gown that would be under the classification of a surgical isolation gown.

However, there would be no reference to PB70 classification. Meaning, there 

would be an expectation of a Level 3 or a Level 4. And you're questioning 

whether or not we would review that?

(Caroline Netelli): Yes.

Terrell Cunningham: Now, I will simply make this as an initial response. While it's a voluntary 

standard, you don't have to comply. However, given the fact that it is a 

medical device, the agency expects you to have evidence that that product will 

perform as a barrier as expected.

Whether or not you make a choice to put it in your labeling that it's a Level 3 

or a Level 4, I believe that could actually be at the discretion of management.

Your product line manager.

However, I'll question whether or not that product would be as competitive on 

the market as those other products that would be clearly labeled with that level 

of effectiveness.

But however, to answer your question, there is no requirement that it be 

labeled as such. However, you would have to have testing data to support that 

function and that is claimed. I wouldn't say claim, but that it performs at that 

level.

(Caroline Netelli): Okay. Thank you. And then my second question is, the AAMI standard PB70 

described only isolation gowns with backs. But there are many products on 

the market marketed as isolation gowns that don't have backs. So, would FDA 
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consider a garment used for high fluid protection in medical settings without a 

back to be considered an isolation gown?

Terrell Cunningham: I have my thoughts. But rather than I tell you what I think, I think it would 

be best that we actually discuss that question within the agency and give your

firm a response.

So again, if you would email that question to us and we will get back with 

you. Because when you look at our understanding of an isolation gown, that 

gown should provide you full coverage front and back.

That would be FDA's expectation of such a product. That is how surgical 

gowns and isolation gowns differ in terms of full coverage as well as the level 

of various protection.

(Caroline Netelli): Okay. The reason that we ask this question, it kind of goes back to the first 

question about includes the AAMI rating with the gown. But we'll submit it to 

you in writing.

Terrell Cunningham: I can understand that - yes. Thank you very much.

Coordinator: The next question is from Mr. (Sole). You may ask your question.

(Sole): Hi. Good afternoon. Thank you for your presentation. With related to the 

isolation gowns that would be considered now a Class 2 medical device, if 

you had an existing product which you were calling a fluid resistant gown 

which would be under the original classification, does that now fall under the 

Class 2 classification and require a 510(k)?
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Terrell Cunningham: It is my understanding that it would. It would be - what, the term you 

referenced would be equivalent to a Level 3 Classification if I'm 

understanding your terminology correct.

(Sole): Yes. So, it would be a fluid resistant would be considered moderate to high 

and record the 510(k)?

Terrell Cunningham: And it should. That is what we would expect that it would be a Level 3.

And any moderate or Level 3 or higher would be subject to 510(k) review.

(Sole): Okay. If you have products, you know, that you had in infantry, is there a 

period time given to slash those out before the 510(k) comes in product with 

510(k) which would be classified with the, you know, Class 2?

Terrell Cunningham: We do have the office of compliance in the room if you would be so kind 

as to repeat the question, please.

(Sole): Okay. If you have products which, you know, have the fluid resistant claim 

which are isolation gowns which would have been, you know, previously 

considered Class 1 are now considered Class 2, is there a period of time to 

flush those out of infantry before, you know, the gowns with the 510(k) is 

Class 2 come in.

(Erin Keith): Yes. This would be a good conversation to have more offline since we would 

have to really get into some discussions in terms of timing to rework your 

product.

And having an understanding that you have in fact submitted a 510(k) and 

have a clear understanding of where things are with the application to market.
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But yes, we would be happy to actually work with you on the phase out, if you 

would, or how to relabel or, you know, reconfigure your product.

(Sole): Right.

(Erin Keith): So that you wouldn't necessarily lose inventory.

(Sole): Okay. And there's no, sort of, sunrise date where those have to be completely, 

you know, out of the system?

Terrell Cunningham: Well, I refer you to Page 9 of the guidance document. And that is where 

we clearly communicate what our expectations are.

(Erin Keith): Right.

(Sole): Right. That would be the June - having to have everything in place by June the 

6th?

(Erin Keith): That's about right. Yes.

(Sole): Yes. Okay. And these particular products, you know, would be tested. In 

manufacture we would have to, if asked, provide evidence that we're doing, 

you know, 32 tests, you know, to the PB70 with an AQL of 4%.

Terrell Cunningham: You appear to have gone into great detail. So, if you would have a follow 

up question that you would want a response, I would exercise the option of 

emailing the question and we will get back to you.

(Sole): Okay.
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Terrell Cunningham: Thank you.

(Sole): All right. And that's to DICE at fda.hhs.gov?

Terrell Cunningham: Yes.

(Sole): Okay. All right. Well, thank you.

Terrell Cunningham: You're welcome.

Coordinator: Our next question comes from (Josh Uller). You may ask your question.

(Josh Uller): Hi. Thank you for the session today. We have a couple of questions to clarify 

just because it seemed a little ambiguous. So, for a single use product there is 

no shelf life claim required? I just want to confirm that that's the case.

Terrell Cunningham: That is true.

(Josh Uller): Okay. With that in mind, for the 510(k) submission, are you expecting us to 

submit aging data as well?

Terrell Cunningham: When you look at - A, is it - what are you referencing? A sterile?

Nonsterile?

(Josh Uller): Nonsterile.

Terrell Cunningham: What are your claims? If in fact, you're looking at a nonsterile surgical 

isolation gown, then that's your question, there's no requirement for sterility, 

nor is there aging requirement.
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Because there - the concerns about aging is related to products that would be 

sterile or products that would have other types of claims. Products that would 

be reprocessed. That's when we start looking at our concerns of aging. And -

on top of...

(Josh Uller): You know what? Appreciate it. My next question is, can you recommend a 

predicate device to look at? We're looking specifically at a nonsterile AAMI 3 

gown, isolation gown. And because these haven't been approved in the past 

we've been having some difficulty finding predicates.

Terrell Cunningham: That is totally beyond the scope of today's presentation. What I would 

recommend you, is look at the 510(k) summaries that are present on the Web.

(Josh Uller): Okay.

Terrell Cunningham: The some senior type of product.

(Josh Uller): Okay. Now that - so you've clarified too that isolation...

(Erin Keith): Hi. Hi.

(Josh Uller): Oh, go ahead.

(Erin Keith): Hi. I'm sorry. This is (Erin Keith) again. I wanted to say that you could also, 

for some of these more product specific questions, there is also a presubmission process that has its own guidance document on the FDA website.

That describes the process where you can ask us more directive and specific 

questions about your product and what sort of testing requirements would be 

necessary for the design features and the claims that you want to make.
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(Josh Uller): Okay. I just have one last question that you may defer to that as well, but I 

should probably ask while I'm here. For a gown made with a material that 

meets any three requirements, but does not meet the seam requirements and 

know any three claim is made, is that considered a Class 2 device? So it's 

made at any close with that detail.

Terrell Cunningham: That is Terrell again. What you're posing is a very product specific type 

of question. I think that would be best handled via our pre-submission process 

as a worst case scenario, or by direct contact with me in the office and we can 

just - we can actually look at your question.

(Josh Uller): Perfect. Thank you very much. I think there's one other person who might 

maybe - oh, no. Never mind. Thank you very much for your time. Appreciate 

it.

Coordinator: Our next question comes from (John Salt). You may ask your question.

(John Salt): Good afternoon. This is (John Salt) here at Precept. And my question is 

similar to Cardinal's question. And right now, roughly based on market data 

for non-surgical gowns used, whatever they're called in a hospital, let's say 

approximately 40% of those gowns used, nearly half are where nurses are 

using an isolation gown called something other than a surgical gown.

They're using an isolation gown, and for comfort they have an open back. For 

protection it varies. According to your guidance, if somebody seeks moderate 

or high protection, they can't have a product. Are you proposing to eliminate 

that 40% of the market and have it change?
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Or is this some confusion factor given its public knowledge that right now the 

F23 ASTM Committee is now trying to figure out a new isolation gown 

standard. So, in that sense, I'm saying the 510(k) is being issued at the same 

time that the F23 Committee is trying to grapple with, you know, issues.

Terrell Cunningham: Well...

(John Salt): And maybe this relates to, on your 510(k) guidance on Page 9 under .3, it's a 

representative drawings et cetera, et cetera, and include the mentions and 

location of the critical and noncritical zones.

So, for an isolation gown, the way the standard was developed, you know, 12 

or 14 years ago, the whole gown is, you know, considered to be a critical 

zone, but as anybody would know looking at the back of the gown, all of 

those gowns will fail the PB70 test because it's open in the back no matter 

how you cut it.

Terrell Cunningham: Well, again, this is a question that goes beyond the scope or the 

expectation of today's presentation. Because what we are actually discussing 

is a product that has newly evolved and it is...

(John Salt): This product's been around forever. This product's been around for 20 years.

These types of products. Open back, over the head gowns have been around 

for a long time.

Terrell Cunningham: Well, just to my knowledge, having been here at FDA for 20 years, I am 

totally unaccustomed to having reviewed, and we're talking about 20 years of 

review, I'm not accustomed to having reviewed an isolation gown with an 

open back because the device design would have been confirmed.
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(John Salt): And I think that's because until these guides came out they were not subject to 

review. I think that's what the buy is in...

Terrell Cunningham: Well, I think...

(John Salt): In that sense, whether I'm right or wrong, I feel like my question, kind of, fits 

with Cardinal's question.

Terrell Cunningham: Well, I think your question...

(John Salt): It may be - if I could be, you know, a precept could be included in that, that 

may help us. We're just trying to understand what the agency's intent here is 

with, based on GHX, kind of, information.

I may be off. It could be 30% or just 1/3. There's a huge amount of gowns 

being used with an open back called isolation gowns, and the clinical workers 

do care about the protection level as well.

Terrell Cunningham: Well I, again, I recommend that you forward that question to DICE using 

the slide that's posted. And also that we can openly address this question in 

F23.

(John Salt): Okay. And our representative (Shane) will be there to talk with you Terrell.

Thank you.

Terrell Cunningham: Because I think that would - and it's not so much talk with me, it's 

something that we need to speak to as a committee, because that's...
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(John Salt): Okay. I do believe that the - this is something that the committee should be 

able to clarify, or that if they have a role to play, they should have already 

clarified this by now and actually I would think.

Terrell Cunningham: And I think...

(John Salt): But the half of it's been out many years in a committee, so and the name of the 

lady is - the state too. I guess, well, (Shane) will speak to you Terrell, or 

whoever else he needs to. We cannot see our slides today, so that's why I'm 

not sure how to spell the name AAMI. Thank you.

Terrell Cunningham: You're welcome.

Coordinator: Our next question comes from Donna Swenson. You may ask your question.

Donna Swenson: Hi. This is Donna Swenson. I'm the coach here at PB70. And I have a 

question on where do the decontamination gowns that are used in sterile 

processing departments fall in this new guidance?

Are - they're definitely protective attire, and my personal opinion is they 

should be Level 3, or Level 4 protective attire. So, but they typically are not 

isolation gowns in that they're not total protection back and front. So, do you 

need - are these considered isolation gowns? Are they considered surgical 

gowns where you have critical zone? Not clear where these really fall then.

Terrell Cunningham: Donna, you pose a very good question, and neither am I at this time 

because in their absence of a clear indication for use, in the absence of product 

labeling.
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Those are all issues that we would have to look at to make a determination.

So, for formal review and to address it, again, what you would forward that 

question and concern for DICE at fdahhs.gov and we will get back to you.

Donna Swenson: Okay. Thank you.

Terrell Cunningham: Our next question comes from (Josh Uller). You may ask your question.

(Josh Uller): One of my coworkers just had a quick question to get some clarification.

Man: Hello. My question falls very in line with (Precepts) and Cardinal's around our 

group trying to understand the applicability of gowns sold into the markets.

So, based on our knowledge, about 48% of what we would call gowns used in 

health care setting have - are marketed either as fluid resistant, impervious, 

impermeable, any of those descriptors that you used before.

Out of those 48%, less than 2% are AAMI compliant. So you would only have 

2% of the gowns that would actually meet AAMI 3 or AAMI 4 based on the 

standards due to either the product not passing it to seams due to the fact that a 

lot of fluid resistant gowns have sewn seams.

Or, due to the fact that the largest gown style in the market have an open back.

So we're really grappling with half of the gowns that are currently sold into 

health care, how we would fit those into your guidance.

So that's the first question. The second one would be all of these questions, 

we're just hoping we can also get the feedback if Cardinal or Precept or 

anyone has asked that question that's applicable to get the industry knowledge 

to understand that feedback because, you know, we are struggling with how to 

classify these gowns.
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Terrell Cunningham: Well, from a regulatory perspective, if I'm hearing you correct, you'll have 

gowns that are labeled as fluid proof, fluid resistant. However, you question 

whether or not they would pass PB70? And it's in fact, that is the clarity that is 

the question that I have a concern about accuracy promotional product in the 

market.

Man: I think that the concern would be that the material used would be referred to 

as a test so that fluid resistant would be a term that's used for a product that's, 

say it's a film.

But either has an open back or the technology to close the seams is a sewn 

technology. So, I would agree that ANSI is looking at adjusting their 

standards to more reflect what's happening in the market.

But it is a challenge for us when the gown coming into the market is marketed 

as fluid proof, and more - half of the gowns today are, but that doesn't 

necessarily correlate to the AAMI standards.

It might correlate to a cap within the standard for the material, but the gown 

itself, the whole gown; the whole critical zone doesn't meet it. So we're trying 

to understand if we need to take fluid resistant off our labeling. It's a challenge 

for us to really understand how to react. And specifically on a very tight 

timeline.

(Erin Keith): Hi. This is (Erin Keith). So, I would say at a high level in answering your 

question, this is the sort of situation where the part of the guidance document 

talks about or equivalent tests to the PB70 test.
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That the standard has its scope and it deals with what it defines. And when 

you have a product that falls within the scope of that, then it's easy to meet the 

requirements, the test requirements of the standard to be able to have it match 

up with your claims and, sort of, develop the data that you need to support 

your marketing applications.

It's harder when you have a design variation what the standard is covering.

And this is where talking with INCV during the pre-submission process about 

the types of information to submit in order to substantiate the claims you want 

to make for your specific device would be the best place to have this 

conversation.

Because it would require the technical people in the branch to have a little bit 

better understanding about the device and that's going to involve some trade 

secret confident information I'm quite certain you don't necessarily want to 

discuss in this webinar.

And so I think that the pre-submission process for an offline phone call with 

the Infection Control Devices branch would be the best way to get some of 

that information to you.

Man: Okay. Perfect. I think just, our main concern is that a macro level half the 

gown is going into the market have a fluid claim. And we just don't 

understand. This is not specifically just for our company or, you know, it's 

consistent across the entire market.

So our concern is with the timelines, if it's a gown that comes in the market on 

June the 6th or even exists in the market no longer are allowed to be sold, 

there could be a big disruption to what's going on right now in the health care 

marketing that day.
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(Erin Keith): Okay. That's a fair point. And so, what I would suggest that you then do is that 

you have a conversation also with the Office of Compliance about the 

logistics and the implications of me being the currently established grace 

periods that are in the guidance document to see how the office feels about an 

extension of those.

Man: Okay. Well, hope - yes. We appreciate your time, and hopefully through the 

direct emails we can get more direct clarity on how to proceed.

Coordinator: Our next question comes from (Mike Shola). You may ask your question.

(Mike Shola): Hello. I'm sorry to interrupt again. Protective apparel to protect against 

biological agents is used outside of health care. And as such, it migrates into 

health care.

For instance, in a crime scene or accident situation where somebody has to 

pull dead bodies out of a car, people wear protective apparel, and it needs to 

be impervious, or AAMI Level 3 or 4.

And I just want to make sure that I understand that the agency is not trying to 

regulate those garments that are used outside of health care. Because, you 

know, if you were a sewage worker in Philadelphia and a sewage line broke, 

you would probably want the same protection that a health care worker would.

(Erin Keith): Hi. This is...

(Mike Shola): To go in that sewage line and repair it.
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(Erin Keith): This is (Erin Keith). We - the guidance document only applies to things that 

are medical devices that meets the specific scope of what the guidance 

document is dealing with.

If you have questions about other applications or other products, there are 

different mechanisms in which to receive feedback on that. One of them 

would be the 513G process where you could submit for clarity on the standing 

of other products.

(Mike Shola): I'm sorry. What was that process again?

(Erin Keith): It's referred to as the 513G submission process. And you can send a question 

related to that to the DICE email address and we can get you linkages to 

information about how to go about doing that.

(Mike Shola): Okay. Thank you.

Irene Aihie: I believe that was our last question. Thank you. This is Irene Aihie. We 

appreciate your participation and thoughtful questions. Today's presentation 

and transcript will be made available on the CDRH Learn Web page at 

www.fda.gov/training/cdrhlearn by Thursday January 28.

If you have additional questions about the final guidance document, please use 

the contact information provided at the end of this slide presentation. As 

always, we appreciate your feedback. Again, thank you for participating. This 

concludes today's webinar.

Coordinator: Thank you. This concludes today's conference. Participants, you may 

disconnect at this time.
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END