**Date: 23 June, 2003**

**FROM: Malaysian Rubber Glove Manufacturers Association (MARGMA)**

**A2-20 PJ Industrial Park,**

**Jalan Kemajuan, Sec.13,**

**46200 Petaling Jaya**

##  Selangor, Malaysia

**Tel: 603-7957 8362**

**E-mail: <margma@tm.net.my>**

**TO: Dockets Management Branch (HFA-305),**

> **Food and Drug Administration,**
>
> **5630 Fishers Lane, Rm. 1061,**
>
> **Rockville, MD 20852.**

Reference : Docket: No. 00D-1384.

Subject: Import Alert IA 80-04

The Malaysian Rubber Glove Manufacturers Association (MARGMA) is an
association of 52 manufacturers of medical gloves. See Attachment 1 for
a list of current glove manufacturers who are members of MARGMA.

MARGMA manufacturers shipped about 1.2 billion pairs surgeons' gloves
and 8.7 billion pairs examination gloves to the Unites States in year
2002.

The following comments are submitted by MARGMA, representing 52
manufacturers, and were developed with the collaboration of our US
Regulatory Affairs Consultant, Mr. Andrew Lowery.

MARGMA notes that the present or proposed 800.20 is implemented with 21
CFR Part 820 GMP/QS and Import Alert #80-04. Therefore, MARGMA
respectfully requests that FDA review the current Import Alert #80-04
guidance, "Surveillance and Detention without Physical Examination"
\[DWPE\] together with the new proposed rule identified immediately
below:

800.20 Medical Devices; Patient Examination and Surgeons' Gloves; Test
Procedures and Acceptance Criteria.

Reference: Docket No. 03N-0056.

Federal Register: March 31, 2003 (Volume 68, Number 61) (Proposed Rules)
(Page 15404-15417) 21 CFR Part 800

Sincerely Yours,

President

**Malaysian Rubber Glove Manufacturers\' Association**

COMMENTS ON IA 80-04

MARGMA has submitted two proposed changes/approaches for Level 3:

> one, delete Level 3 and enhance Level 2; and,
>
> two, modify Level 3.

If the first one is not accepted, then MARGMA respectfully requests that
FDA consider the second request.

GENERAL COMMENTS

FDA Review IA 80-04 with 800.20

In view of the lowering of AQL levels for both surgeon and examination
glove, MARGMA wishes to propose that FDA review the current Import Alert
#80-04 guidance, \"Surveillance and Detention without Physical
Examination\" together with the new proposed rule 800.20.

Rationale: 21 CFR 800.20 is not a standalone regulation. It is
implemented in conjunction with IA 80-04. Therefore, in order to be
synergistic, avoid conflicts, and not be overly burdensome, the two
documents should be reviewed together.

FDA Inform Manufacturers of Sampling

MARGMA requests that FDA make appropriate changes in IA 80-04 and
associated import and analyst forms so that manufacturer contact
information is collected. MARGMA manufacturers request that FDA, in a
timely manner, inform them by letter, Fax, or email when one of their
shipments is detained and inform them of the results of the sampling and
testing.

**Rationale**: Manufacturers wish to be informed/notified directly by
the FDA whenever one of their containers is held for sampling and
examination; and, we wish to be directly informed of the outcome of the
visual inspection and water leak testing. Currently, often after
significant delays, MARGMA manufacturers learn about the detention of
their gloves from their customers or shippers or sometimes in the OASIS
webpage. This delay, in turn, delays initiation of our CAPA activities.

**IA 80-04 Accept Enhanced Test Passes**

MARGMA requests that reconditioned gloves that do not undergo physical
reworking and that pass the testing under the tightened sampling plan be
allowed to be distributed as passed; and, the passed lot be classified
as a passed lot under IA 80-04.

**Rationale**: The gloves have passed enhanced sampling and testing and
have enhanced assurance of meeting quality requirements. Also, this
change would make IA 80-04 consistent with the Food, Drug, and Cosmetic
Act.

Classification Versus 510(k)

When a manufacturer has one type of examination glove detained, all of
their various examination gloves are detained because detention is
presently performed based on one classification regulation for all
examination gloves. The same is true for surgeons' gloves. MARGMA
requests that detention be applied per glove 510(K) instead of per glove
classification regulation.

Rationale: Detention should be applied per glove 510(K) instead of per
classification regulation. Gloves are not manufactured per a
classification regulation. Gloves are manufactured according to the
specifications and information in the 510(k) submission.

For example, under the classification approach, a detention of Nitrile
powdered gloves results in NRL powder-free gloves being detained.
Nitrile and NRL gloves are made with:

-   different materials,

-   different formulations,

-   different process parameters, and

-   usually with different equipment.

A failure with one glove type usually has little or no relationship to
the quality of another glove type with a different 510(k) clearance.

Detention by classification regulation instead of by glove 510(k)
results in extremely unfair punishment to glove manufacturers. After a
failure for one type of glove, this classification approach can force a
manufacturer into bankruptcy and/or out of medical glove production when
all of their [other]{.underline} various types of medical gloves
[meet]{.underline} all regulatory and quality requirements. MARGMA is
not aware of FDA routinely applying the same "per classification
treatment" to manufacturers of other medical devices.

IA 80-04 Incompatible with QS/GMP

IA 80-04 Time Element

IA 80-04 is based on quality-related events and time. The GMP is based
only on quality-related events. MARGMA recommends that IA 80-04 be
modified to be more related to quality events rather than time. The
addition of the reconditioning enhanced sampling and testing program is
a step in the right direction because it is a quality event-related
program. Likewise the 5 and 10 good shipments criteria are quality
events. MARGMA also requests that the detention probation period be
reduced from 24 to 12 months.

Rationale: IA 80-04 contains time elements whereas the GMP is based on
events. The time element makes IA 80-04 a very complex policy and very
punitive for medical glove manufacturers. Changing IA 80-04 to be based
more on quality events and less related to time would make it more
compatible with the GMP and less punitive.

IA 80-04 Has Late CAPA; GMP Requires Early CAPA

IA 80-04 needs to emphasize CAPA at Level 1 rather than at Levels 2 and
3.

Rationale: The emphasis on corrective action in IA 80-04 occurs at Level
2 and 3.

CAPA in the GMP regulation emphasizes corrective action when the
manufacturer becomes aware of a problem which would be Level 1.

COMMENT BY TOPIC

The *REASON FOR REISSUANCE* states that "A new procedure was developed
for detention without physical examination of gloves manufactured by
firms who repeatedly import non-compliant products."

In contrast, the *NOTE* under *Guidance* states that, "Because the
presence of defects in medical gloves represents a potential hazard to
health, only one (1) violative sample is needed to submit a
recommendation for detention without physical examination to the
Division of Import Operations & Policy (DIOP).

Recommendation: The *REASON FOR REISSUANCE* and the *NOTE* under
*Guidance* need to be rewritten so that they become compatible
statements.

Rationale: "Repeatedly import non-compliant products" and "only one (1)
violative sample is needed to submit a recommendation for detention" are
incompatible statements. That is, one violation is not repeated
violations.

Level 1 Detention(INDICATED BY \* IN ATTACHMENT A)

We recommend that the above heading be changed to:

'Level 1 [DWPE and Probation']{.underline}(INDICATED BY \* IN ATTACHMENT
A).

\[Where DWPE is detention without physical examination\]

MARGMA recommends that this section be re-written as identified by the
following underlined text:

When a district encounters a shipment of medical gloves which is found
violative for defects by FDA analysis, the shipment should be detained
and a recommendation for detention without physical examination (DWPE)
should be forwarded to DIOP, HFC-170.

If the recommendation meets current guidance, the manufacturer/shipper
will be placed on [Level 1 DWPE for the specific type of glove and
510(k),]{.underline} attachment \"A\" with a single asterisk(\*), [and
placed on 12 months probation. The 12 months of probation starts on the
date the firm was placed on DWPE.]{.underline} Subsequent medical glove
shipments from that manufacturer/shipper may be detained without
physical examination under this import alert. The manufacturer/ shipper
may obtain admission of subsequently detained shipments of medical
gloves by presenting evidence that the individual shipments are not
adulterated, such as sample analyses performed by an independent testing
laboratory, following the sampling plan and test method contained in FDA
[current]{.underline} guidance [or current regulation.]{.underline}

In order for the responsible manufacturer\'s/shipper\'s name to be
removed from [Level 1]{.underline} [DWPE]{.underline} and attachment
\"A,\" documentation should be provided with sufficient evidence that
their [specific type]{.underline} of medical glove [as identified by a
510(k) number is]{.underline} not adulterated (for example, five
consecutive non-violative shipments analyzed as described in the
preceding paragraph may be considered adequate evidence for
manufacturers/shippers to be removed from Level 1 [DWPE for the specific
type \[specific 510(k)\] of glove. The manufacturer/shipper remains on
Level 1 probation for 12 months]{.underline}).

Rationale:

IA 80-04 needs to make it clear that the end of Level 1 or 2 DWPE is not
the same as the end of Level 1 or 2 "probation." IA 80-04 is not clear
with respect to the end of Level 1 DWPE after 5 consecutive good
shipments and the end of Level 1 "probation" after 24 months with no
entry failures. For example, IA 80-04 states:

> In order for the responsible manufacturer\'s/shipper\'s name to be
> removed from attachment \"A,\" documentation should be provided with
> sufficient evidence that their medical gloves are not adulterated (for
> example, five consecutive non-violative shipments analyzed as
> described in the preceding paragraph may be considered adequate
> evidence for manufacturers/shippers to be removed from Level 1
> detention).

This statement appears to state that 5 good shipments removes the firm
from Level 1 detention when the firm is actually on 'Level 1
detention-probation' for 24 months.

IA 80-04 and the GMP/QS Regulation

We further recommend that the following be added to the Level 1 section:

[Without regard to the status of the 5 consecutive good shipments,
during the 12 months probation FDA may ask the manufacturer to submit to
CDRH an outline and schedule of the CAPA activities proposed or underway
per 21 CFR 820.100 that are intended to identify and correct the cause
of the deficiency. The cover letter or document to FDA shall state that
the manager with executive responsibility is aware of the deficiency or
deficiencies and CAPA activities. FDA may or may not reply to the
manufacturers documents.]{.underline}

Rationale: IA 80-04 is not consistent with 21 CFR §820.100 of the GMP/QS
regulation. The corrective actions in the present IA 80-04 are too late
-- corrective action in §820.100 CAPA are intended to start as soon as
the manufacturer becomes aware of a quality or system problem. The
change recommended above is intended to help make IA 80-04 more
consistent with the GMP regulation.

Level 2 Detention

We recommend that the heading be changed to: [Level 2 DWPE and
Probation]{.underline}

We recommend that this section be re-written for the same reasons
(rationale) given above for Level 1. The revised text is as follows:

**[Level 2 DWPE and Probation]{.underline}** \-- (Recidivist firms which
are currently on Level 1 [DWPE]{.underline}, or which have been removed
from Level 1 [DWPE)]{.underline} (INDICATED BY \*\* IN ATTACHMENT A)

If a manufacturer/shipper, while on Level 1 [DWPE]{.underline}, has a
violative sample analyzed by a private laboratory, the district should
notify DIOP and submit supporting documentation. DIOP will place the
firm on Level 2 [DWPE and 12 months probation for the one or more
specific violative glove types with specific 510(k) numbers]{.underline}
and identify the manufacturer/shipper on attachment \"A\" with two
asterisks (\*\* ). [The manufacturer/shipper goes to Level 2 DWPE if the
glove type is the same or different from the glove type that triggered
the Level 1 status. Level 2 is based on the **sum** of failures of all
glove types; for example, 1failure of textured pink powdered NRL, and 1
failure of purple powder-free Nitrile results in Level 2 status.
However, Level 2 DWPE does not apply to gloves types that have not
failed \[are not violative\].]{.underline}

Similarly, if a manufacturer/shipper that has been removed from Level 1
[DWPE]{.underline} has a violative sample analyzed by FDA within 12
months from the date they were removed from Level 1 [DWPE]{.underline},
the district should notify DIOP and submit supporting documentation.
DIOP will verify the manufacturer/shipper was listed under Level 1
detention [probation]{.underline} during the past [12]{.underline}
months and if confirmed will place the manufacturer/shipper on Level 2
[DWPE and 12 months probation]{.underline} and identify the
manufacturer/shipper on attachment \"A\" with two asterisks(\*\* ).

DIOP will bring this action to the attention of CDRH.

Delete the paragraph below because CAPA is started under Level 1 and
continues under Level 2. CAPA is more detailed and, therefore, is more
effective than this following paragraph.

> Based on this second listing within 24 months, CDRH has agreed to
> notify the foreign firm in writing of FDA\'s concerns about potential
> deficiencies in the manufacturing practices and process controls which
> may be affecting the quality of the medical gloves shipped to the U.S.
> A copy of the Good Manufacturing Practices (GMP) Regulations will be
> provided with the letter for their information.

[After]{.underline} a manufacturer/shipper is placed on Level 2 [DWPE
and placed on 12 months probation,]{.underline} FDA may need greater
assurance that the medical gloves are not adulterated before removing
the manufacturer/shipper from [DWPE]{.underline} status. For example, 10
consecutive non-violative shipments [for each type \[each 510(k)\] of
glove involved]{.underline}, analyzed by an independent testing
laboratory [and CAPA information as stated below,]{.underline} may be
considered adequate evidence that the manufacturer/ shipper is shipping
medical gloves to the U.S. which are not adulterated. [The firm remains
on detention probation for the remainder of the 12 months]{.underline}.

[FDA will ask the manufacturer to submit an outline and schedule of the
CAPA activities proposed or underway per 21 CFR 820.100 that are
intended to identify and correct the cause of the deficiency or
deficiencies; and, FDA will ask at the same time that follow-up CAPA
reports and summaries of the data for each lot of the subject glove
types be submitted within 6 months. Each cover letter or document to FDA
shall state that the manager with executive responsibility is aware of
the deficiency or deficiencies and CAPA activities. FDA may or may not
reply to the manufacturers document submissions.]{.underline}

[]{.mark}

[Additional and subsequent CAPA data and]{.underline} other types of
evidence to remove the appearance of violations may be requested FDA and
will be evaluated by CDRH on a case-by-case basis.

[Manufacturers may submit additional and subsequent CAPA data and QS
improvement information to FDA and request removal from Level 2 at the
end of 12 months on a case-by-case basis for low volume specialty gloves
or the specific glove type where it would take more than 12 months to
accumulate 10 shipments.]{.underline}

MARGMA requests that Level 3 be removed from IA 80-04 and our rationale
follows. MARGMA proposes that the manufacturers/importers in default
remain under detention Level 2, regardless of additional failures, until
the manufacturers/ importers corrects their glove quality problems. All
shipments of the violative types undergo enhanced sampling and testing
by private independent labs or by FDA. *\[However, if FDA elects to
retain Level 3, MARGMA requests that Level 3 be changed as noted in the
next section with underlined text.\]*

**[Rationale for removal of Level 3 from IA 80-04:]{.underline}** See
comments to docket No. 00D-1384. MARGMA had observed and commented on
the pragmatism of current recidivist policy dated 20 Oct 2000, docket
No. 00D-1384. The policy supports the current QS regulation,
specifically the §820.100 CAPA requirements. When FDA has placed
manufacturers/importers on detention, it is the manufacturer/importers
responsibility to provide greater assurance that they meet the required
AQL. MARGMA proposes that the manufacturers/importers in default remain
under detention Level 2 DWPE, regardless of additional failures, until
the manufacturers/ importers correct their glove quality problems. Then
the manufacturer/shipper requests FDA to remove them from DWPE. The
request must be supported by evidence as set forth in the revised IA
80-04 or in FDA guidance. The recidivist policy should not be punitive
in nature but corrective in practice, allowing the
manufacturers/importers the opportunity to rectify their problems
immediately, especially at the early stages of violation. In all
instances American consumers are fully protected during the
detention period because 100% of the shipments of the violative types
are evaluated by **enhanced sampling and testing** by private
independent laboratories before release/distribution of the gloves into
the US market.

In addition, medical gloves are now commodity products manufactured by a
mature industry; therefore, profit margins are small. Commodity product
manufacturers cannot sustain the cost of continuous testing by private
labs and the disrupted flow of product to their clients. Therefore, they
must immediately solve their quality problems and get off DWPE or face
dire consequences.

If FDA elects to retain Level 3, MARGMA requests that Level 3 be changed
as noted below with underlined text:

Level 3 [No Entry for Failed Types]{.underline} \-- (Recidivist firms
which are currently on Level 2 [DWPE and probation,]{.underline} or
which have been removed from Level 2 [DWPE but still on
probation]{.underline}) (\*\* \* IN ATTACHMENT A DENOTES A WARNING
LETTER IS BEING CONSIDERED BY CDRH[). Level 3 is based on the sum of
failures of all glove types; for example, 1failure of blue powdered NRL,
1 failure of buff textured powder-free polymer-coated NRL and 1 failure
of green powder-free Nitrile results in Level 3 status. However, Level 3
entry denial does not apply to glove types with different 510(k)s where
such glove types have not failed.]{.underline}

If a manufacturer/shipper, while on Level 2 [DWPE or
Probation,]{.underline} has another violative sample analyzed by an
independent testing laboratory, the district should notify DIOP and
submit supporting documentation.

Similarly, if a manufacturer/shipper removed from Level 2
[DWPE]{.underline} has another violative sample analyzed by FDA within
[12]{.underline} months from the date they were removed from Level 1
[DWPE]{.underline}, or the date they were placed on Level 2 detention,
DIOP will bring these instances to the attention of CDRH.

Based on the failure of the manufacturer\'s/shipper\'s medical gloves to
pass FDA analysis \[Section 501(c)\] after being listed on Level 2
detention, or having failed an independent testing laboratory
examination while under Level 2 detention, CDRH may then issue a Warning
Letter to the firm.

Additionally, after reviewing the manufacturer/shipper\'s export and
inspectional history, CDRH may elect to charge the firm for failure to
conform with GMP's \[Section 501(h)\], based on the recurring GMP
deficiencies as revealed by [gross failures]{.underline} (detailed
below) or the repeated failures of analyses.

If CDRH determines a warning letter should issue to the foreign
manufacturer/shipper, DIOP will place the manufacturer/shipper on Level
3 detention (attachment B) [for the specific glove types cleared under
their specific 510(k)s. FDA will deny entry for the specific violative
glove types cleared under their specific 510(k)s.]{.underline}

Non-violative analyses may not be sufficient to remove the appearance of
a violation for manufacturers/shippers on attachment B [for the specific
glove types cleared under the specific 510(k)s]{.underline}.
Manufacturers/shippers [of these specific glove types]{.underline} will
remain on Level 3 detention until evidence is provided to CDRH which
demonstrates that the [specific]{.underline} medical glove
[types]{.underline} are being manufactured in accordance with Good
Manufacturing Practices (for example, an acceptable FDA inspection or a
written certification from the manufacturer/shipper together with the
results of an independent audit performed by a qualified third party).

[After]{.underline} a foreign manufacturer/shipper satisfactorily
demonstrates that the apparent GMP deviations have been corrected, the
manufacturer/shipper will be removed from attachment \"B\" and placed on
attachment \"A\" under the Level 1 detention for individual shipment
analysis [and document submissions]{.underline} to confirm their
[specific medical glove types, cleared under specific
510(k)s,]{.underline} do not contain defects until they provide adequate
evidence to be removed from Level 1 (which see above) DWPE [for each
type of glove. The manufacturer/shipper remains on detention probation
for 12 months from the date they were placed on DWPE]{.underline}

Grossly Defective Gloves

MARGMA recommends that a manufacturer, without regard to previous
detention status, be placed on Level 3 \[or, Level 2 if there is no
level 3\] if a shipment of a specific type of glove is grossly violative
by visual inspection or water leak testing. However, Level 3 entry
denial does not apply to glove types with different 510(k)s where such
glove types have not failed.

Grossly defective gloves usually can be visually identified. Examples of
grossly violative glove conditions are:

-   Large numbers or package of fused/blocked of gloves;

-   Blocked package or large numbers of gloves that cannot be donned;

-   Gloves that have disintegrated into flakes or chips; and

-   Large number of gloves that tear when correctly donned.

> \[A large number can be a number greater than the largest failure
> number for the lot size as established by FDA in the Preamble to
> 800.20 or in the IA 80-04 Policy.\]

Rationale: Such manufacturers need to assure by performing basic life
testing that each type of glove that they produce meet user needs when
delivered. Timely corrective action \[CAPA\] may be delayed by waiting
for the manufacturer to regress through Level 2 and on to Level 3. FDA
needs to be able under IA 80-04, along with other remedies, to
immediately see that CAPA is implemented and that incoming shipments of
the specific glove type are evaluated by enhanced sampling and testing
by a private lab \[or not allowed entry for the specific type of glove
depending on the requirements in the next version IA 80-04\].

Copy of IA 80-04 for reference.

IA #80-04

REVISED 9/11/97, IMPORT ALERT #80-04, \"SURVEILLANCE AND DETENTION
WITHOUT PHYSICAL EXAMINATION OF SURGEON\'S AND OR PATIENT EXAMINATION
GLOVES

ATTACHMENT A - 3/15/01, ATTACHMENT B - 8/1/00

(NOTE: This import alert represents the Agency\'s current guidance to
FDA field personnel regarding the manufacturer(s) and/or product(s) at
issue. It does not create or confer any rights for or on any person, and
does not operate to bind FDA or the public.

REASON FOR REISSUANCE: A new procedure was developed for detention
without physical examination of gloves manufactured by firms who
repeatedly import non-compliant products.

TYPE OF ALERT: Surveillance (Physical Examination), and Detention
Without Physical Examination

PRODUCT: Surgeon\'s and Patient Examination Gloves

PRODUCT CODE: 80LZA, 80FMC, 80LYY, 80LZC, 80LYZ, 79KGO

PAC: 82Z003

PROBLEM: Defective per 21 CFR 800.20 - Leaks, tears, mold, embedded
foreign objects

COUNTRY: Surveillance - All Countries - (ZZ) Detention Without Physical
Examination - See Attachments (A & B)

MANUFACTURER/ SHIPPER: See Attachments (A & B)

MANUFACTURER/ SHIPPER ID#: N/A

IMPORTER\'S ID #: N/A

CHARGE: \"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to contain defects/holes
\[Adulteration, section 501(c).\]\"

When FDA has documented repeated violations, and the
manufacturer/shipper has been issued a Warning Letter and listed in
Attachment B of the Recidivist Policy described below, future shipments
may be detained charging the following:

\"The article is subject to refusal of admission pursuant to section
801(a)(1) in that it appears that the methods used in, or the facilities
and controls used for, the manufacture, packaging, storage, or
installation of the device do not conform with Good Manufacturing
Practices \[Adulteration, section 501(h), Good Manufacturing Practices,
Section 520(f).\]\"

RECOMMENDING OFFICE: Center for Devices and Radiological Health (CDRH)

REASON FOR ALERT: CDRH has determined that many foreign manufacturers
and shippers of medical gloves have failed to consistently provide
medical gloves of adequate quality for distribution in the U. S.
Surgeon\'s and examination gloves are widely used by health care
professionals and others as a barrier to blood-borne diseases and
pathogens. Defective medical gloves present a potential hazard to health
for users as well as patients. Therefore, continuous monitoring of these
medical gloves is needed.

GUIDANCE: Districts may detain without physical examination, all
shipments of surgeon\'s and patient examination gloves from the
manufacturers/shippers listed on the attachments to this alert.

Surveillance sampling of other manufacturers/shipper\'s surgeon\'s and
patient examination gloves per the most recent guidance is indicated.

NOTE: Because the presence of defects in medical gloves represents a
potential hazard to health, only one (1) violative sample is needed to
submit a recommendation for detention without physical examination to
the Division of Import Operations & Policy (DIOP). DIOP has direct
reference authority for detention without physical examination of these
medical gloves. Violative medical gloves are subject to RPM Chapter 9,
Detention Without Physical Examination, subchapter \"Recommendations
Based on One Sample.\"

The following strategy has been established to address those
manufacturers/shippers who are found to repeatedly ship violative
medical gloves to the U.S. (recidivist firms.)

Level 1 Detention (INDICATED BY \* IN ATTACHMENT A)

When a district encounters a shipment of medical gloves which is found
violative for defects by FDA analysis, the shipment should be detained
and a recommendation for detention without physical examination should
be forwarded to DIOP, HFC-170.

If the recommendation meets current guidance, the manufacturer/shipper
will be placed on attachment \"A\" with a single asterisk(\*), and
subsequent medical glove shipments from that manufacturer/shipper may be
detained without physical examination under this import alert. This is
referred to as \"Level 1 detention.\" The manufacturer/ shipper may
obtain admission of subsequently detained shipments of medical gloves by
presenting evidence that the individual shipments are not adulterated,
such as sample analyses performed by an independent testing laboratory,
following the sampling plan and test method contained in FDA guidance.

In order for the responsible manufacturer\'s/shipper\'s name to be
removed from attachment \"A,\" documentation should be provided with
sufficient evidence that their medical gloves are not adulterated (for
example, five consecutive non-violative shipments analyzed as described
in the preceding paragraph may be considered adequate evidence for
manufacturers/shippers to be removed from Level 1 detention).

Level 2 Detention \-- (Recidivist firms which are currently on Level 1
detention, or which have been removed from Level 1 detention) (INDICATED
BY \*\* IN ATTACHMENT A)

If a manufacturer/shipper, while on Level 1 detention, has a violative
sample analyzed by a private laboratory, the district should notify DIOP
and submit supporting documentation. DIOP will place the firm on Level 2
detention and identify the manufacturer/shipper on attachment \"A\" with
two asterisks (\*\* ).

Similarly, if a manufacturer/shipper that has been removed from Level 1
detention has a violative sample analyzed by FDA within 24 months from
the date they were removed from Level 1 detention, the district should
notify DIOP and submit supporting documentation. DIOP will verify the
manufacturer/shipper was listed under Level 1 detention during the past
24 months and if confirmed will place the manufacturer/shipper on Level
2 detention and identify the manufacturer/shipper on attachment \"A\"
with two asterisks(\*\* ).

DIOP will bring this action to the attention of CDRH.

Based on this second listing within 24 months, CDRH has agreed to notify
the foreign firm in writing of FDA\'s concerns about potential
deficiencies in the manufacturing practices and process controls which
may be affecting the quality of the medical gloves shipped to the U.S. A
copy of the Good Manufacturing Practices (GMP) Regulations will be
provided with the letter for their information.

Once a manufacturer/shipper is placed on Level 2 detention, FDA may need
greater assurance that the medical gloves are not adulterated before
removing the manufacturer/shipper from detention without physical
examination status. For example, 10 consecutive non-violative shipments,
analyzed by an independent testing laboratory, may be considered
adequate evidence that the manufacturer/shipper is shipping medical
gloves to the U.S. which are not adulterated. Other types of evidence to
remove the appearance of a violation will be evaluated by CDRH on a
case-by-case basis.

Level 3 Detention \-- (Recidivist firms which are currently on Level 2
detention, or which have been removed from Level 2 detention) (\*\* \*
IN ATTACHMENT A DENOTES A WARNING LETTER IS BEING CONSIDERED BY CDRH)

If a manufacturer/shipper, while on Level 2 detention, has another
violative sample analyzed by an independent testing laboratory, the
district should notify DIOP and submit supporting documentation.

Similarly, if a manufacturer/shipper removed from Level 2 detention has
another violative sample analyzed by FDA within 24 months from the date
they were removed from Level

1 detention, or the date they were placed on Level 2 detention, DIOP
will bring these instances to the attention of CDRH.

Based on the failure of the manufacturer\'s/shipper\'s medical gloves to
pass FDA analysis \[Section 501(c)\] after being listed on Level 2
detention, or having failed an independent testing laboratory
examination while under Level 2 detention, CDRH may then issue a Warning
Letter to the firm.

Additionally, after reviewing the manufacturer/shipper\'s export and
inspectional history, CDRH may elect to charge the firm for failure to
conform with GMP's \[Section 501(h)\], based on the recurring GMP
deficiencies as revealed by the repeated failures of analyses.

If CDRH determines a warning letter should issue to the foreign
manufacturer/shipper, DIOP will place the manufacturer/shipper on Level
3 detention (attachment B).

Non-violative analyses may not be sufficient to remove the appearance of
a violation for manufacturers/shippers on attachment B.
Manufacturers/shippers will remain on Level 3 detention until evidence
is provided to CDRH which demonstrates that the medical gloves are being
manufactured in accordance with Good Manufacturing Practices (for
example, an acceptable FDA inspection or a written certification from
the manufacturer/shipper together with the results of an independent
audit performed by a qualified third party).

Once a foreign manufacturer/shipper satisfactorily demonstrates that the
apparent GMP deviations have been corrected, the manufacturer/shipper
will be removed from attachment \"B\" and placed on attachment \"A\"
under the Level 1 detention for individual shipment analysis to confirm
their medical gloves do not contain defects until they provide adequate
evidence to be removed from Level 1 detention (see above).

For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology, contact
the Division of Field Science at (301)

443-3320 or 3007.

For questions concerning 21 CFR 800.20, CPG 7124.31, medical glove
labeling, or other compliance issues, contact CDRH, Office of
Compliance, Division of Enforcement II at (301)

594-4618.

SAMPLING: See 21 CFR 800.20(c) for sample plans.

All sizes should be represented as closely as feasible to the proportion
which they exist in the shipment, however, exact statistical
representation is not necessary. If the sample is found violative, all
sizes should be detained.

When an entry consists of only one size, attempt to collect as many lot
numbers as possible. For example, if during a random sample collection
three lot numbers are observed, represent them all as subs within one
sample. If the sample is found violative, all lots should be detained.

If a shipment is detained based on the analysis of one lot and
subsequently it is learned that there were 10 lot numbers present, the
detention stands.

**ATTACHMENT 1:**

LIST OF MEMBER COMPANIES

**\[ORDINARY (Manufacturing) MEMBERS\]**

**MALAYSIAN RUBBER GLOVE**

**MANUFACTURERS' ASSOCIATION**

**(MARGMA)**

+-----------------------------------+----------------------------------+
| 1.  Alliance Rubber Products Sdn  | 26. Oon Corp Resources (M) Sdn   |
|     Bhd                           |     Bhd                          |
|                                   |                                  |
| ```{=html}                        | 27. Pan Century Rubber Products  |
| <!-- -->                          |     Sdn Bhd                      |
| ```                               |                                  |
| 1.  Ansell (Kedah) Sdn Bhd        | 28. Perusahaan Getah Asas Sdn    |
|                                   |     Bhd                          |
| 2.  APL Healthcare Sdn Bhd        |                                  |
|                                   | 29. Perusahaan Pelindung         |
| 3.  Apollo Rubber Sdn Bhd         |     Getah (M) Sdn Bhd            |
|                                   |                                  |
| 4.  Brightway Holdings Sdn Bhd    | 30. Protection Gloves (M) Sdn    |
|                                   |     Bhd                          |
| 5.  Comfort Rubber Gloves         |                                  |
|     Industries Sdn Bhd            | 31. Purnabina Sdn Bhd            |
|                                   |                                  |
| 6.  Concept Rubber Products Sdn   | 32. Quality Latex Products       |
|     Bhd                           |     Malaysia Sdn Bhd             |
|                                   |                                  |
| 7.  Contract Latex Dippers Sdn    | 33. Riverstone Resources Sdn Bhd |
|     Bhd                           |                                  |
|                                   | 34. Sanchem Corporation Sdn Bhd  |
| 8.  Cranberry (M) Sdn Bhd         |                                  |
|                                   | 35. Seal Polymer Industries Sdn  |
| 9.  FELDA Rubber Products Sdn Bhd |     Bhd                          |
|                                   |                                  |
| 10. Flexitech Sdn Bhd             | 36. Seltom Pacific Sdn Bhd       |
|                                   |                                  |
| 11. GB Industries Sdn Bhd         | 37. Smart Glove Corporation Sdn  |
|                                   |     Bhd                          |
| 12. Glovco (M) Sdn Bhd            |                                  |
|                                   | 38. Sri Johani Sdn Bhd           |
| 13. Guthrie Medicare Products     |                                  |
|     (NS) Sdn Bhd                  | 39. SSN Gloves (M) Sdn Bhd       |
|                                   |                                  |
| 14. Handsafe Products Sdn Bhd     | 40. Super Latex Sdn Bhd          |
|                                   |                                  |
| 15. Hartalega Sdn Bhd             | 41. Supermax Corporation Berhad  |
|                                   |                                  |
| 16. IGA Overseas Sdn Bhd          | 42. Tekmedic (M) Sdn Bhd         |
|                                   |                                  |
| 17. JB Star Sdn Bhd               | 43. Terang Nusa Sdn Bhd          |
|                                   |                                  |
| 18. KL-Kepong Rubber Products Sdn | 44. TG Medical (M) Sdn Bhd       |
|     Bhd                           |                                  |
|                                   | 45. Top Glove Corporation Berhad |
| 19. Koon Seng Sdn Bhd             |                                  |
|                                   | 46. Ultrawin Sdn Bhd             |
| 20. Kossan Latex Industries (M)   |                                  |
|     Sdn Bhd                       | 47. Wear Safe (Malaysia) Sdn Bhd |
|                                   |                                  |
| 21. Latexx Manufacturing Sdn Bhd  | 48. WRP Asia Pacifc Sdn Bhd      |
|                                   |                                  |
| 22. Longcane Industries Sdn Bhd   | 49. WRP Senetimed Sdn Bhd        |
|                                   |                                  |
| 23. MAPA (gloves) Sdn Bhd         | 50. YTY Industry Sdn Bhd         |
|                                   |                                  |
| 24. Marcon Rubber Industry Sdn    | 51. Bonric Sdn Bhd               |
|     Bhd                           |                                  |
|                                   |                                  |
| 25. N.S. Uni-Gloves Sdn Bhd       |                                  |
+-----------------------------------+----------------------------------+