Guidance for Industry 

Latex Condoms for Men 
Information for 510(k) Premarket 
Notifications:  Use of Consensus 
Standards for Abbreviated 
Submissions 
Document issued on:  July 23, 1998 
U.S. Department Of Health And Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Obstetric and Gynecology Devices Branch 
Division of Reproductive, Abdominal, Ear, Nose 
and Throat, and Radiological Devices 
Office of Device Evaluation  Preface 
Public Comment 
Comments and suggestions may be submitted at any time for Agency consideration  
to  http://www.regulations.gov. Submit written comments to the Dockets 
Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD 20852. Comments may not be  acted upon by the 
Agency until the document is next revised or updated.  For  questions regarding the 
use or interpretation of this guidance,  contact Susan  Andrews at 870-543-4653 
x4653, or susan.andrews@fda.hhs.gov 
Additional Copies 
Additional copies are available from the Internet. You may also send an  e-mail 
request to CDRH-Guidance@fda.hhs.gov  to receive a copy of the guidance. 
Please use the document number 1250  to identify the guidance you are 
requesting.  Latex Condoms for Men 

Information for 510(k) Premarket Notifications: 

Use of Consensus Standards for Abbreviated Submissions 

Section 510(k) of the Act and the implementing regulation, 21 CFR Part 807, require persons who intend to 
market a new device to submit a premarket notification containing information that enables FDA to determine 
whether the new device is substantially equivalent within the meaning of Section 513(i) of the Act to a legally 
marketed device that does not require premarket approval. Unless exempted from premarket notification 
requirements, persons may not market a new device under Section 510(k) of the Act, unless they receive a 
substantial equivalence order from FDA or an order reclassifying the device into Class I or Class II (section 
513(i) of the Act). Male condoms are classified as Class II devices under 21 CFR 884.5300 and 884.5310 
(Condom with spermicidal lubricant) and are not exempted from 510(k) requirements, therefore, a 510(k) 
premarket notification must be cleared by order of FDA before a new male condom, or one that has been 
significantly changed or modified, is introduced into interstate commerce. 
A person required to submit a 510(k) premarket notification must provide information as required by the statute 
and regulations to allow the Center to make an appropriate decision regarding the clearance of the submission. 
The Center believes that conformance with recognized consensus standards can provide a reasonable assurance 
of safety and/or effectiveness for many aspects of medical devices, including Male Latex Condoms. A 510(k) 
that contains a declaration of conformity to recognized consensus standards, as discussed below, will, in most 
cases, eliminate the need to review the actual test data for those aspects of the device addressed by the 
standards. This, however, does not affect the Center's ability to obtain any information authorized by the statute 
or regulations. Conformance with recognized consensus standards in and of itself may not always be a 
sufficient basis for regulatory decisions. For example, a specific device and/or intended use may raise safety or 
effectiveness issues not addressed by any recognized consensus standard, or a specific FDA regulation may 
require additional information beyond what conformity to recognized consensus standards provide. Under such 
circumstances, conformity with recognized standards will not satisfy all requirements for marketing the latex 
condom in the United States. 
The Center for Devices and Radiological Health has recognized and will use consensus standards pursuant to 
the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), which amends section 514 of the 
Food, Drug, and Cosmetic Act (21 U.S.C. 514(c)). FDA has recognized voluntary consensus standards for 
Latex Condoms for Men, and other relevant standards may also be applicable to the submission of a 510(k) for 
a latex condom, e.g., ISO 10993. A list of recognized standards is maintained on the CDRH website and is 
updated at least annually. Other recognized standards may be applicable for latex condoms and manufacturers 
have the right to make a declaration of conformity to any listed standard.   [FDA Guidance on the 
Recognition and Use of Consensus Standards, February 19, 1998, q.v.] 
Building on FDAs recognition of the ASTM voluntary consensus standard for condoms and the ISO voluntary 
consensus standard for biological evaluation of medical devices, this guidance document provides an outline for 
a 510(k) premarket notification that incorporates a declaration of conformance with these standards. When the 
declaration is combined in a 510(k) which is complete and accurate, it can serve as the basis for an FDA finding 
of substantial equivalence for a Natural Rubber Latex (NRL) Condom. (Other criteria exist for blends and non-
NRL Male Condoms and for Female Condoms.) 
This guidance document represents the agencys current thinking on the use of consensus standards for 
abbreviated submissions for 510(k) Premarket notifications for latex condoms for men. It does not create or 
confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.  Abbreviated 510(k) for Male Latex Condoms  Page 4 of 16 
<< Cover Letter >> 
[Date of Submission] 
Food and Drug Administration 
Center Devices and Radiological Health 
Office of Device Evaluation 
Document Mail Center (HFZ-401) 
9200 Corporate Blvd. 
Rockville, MD   20850 
Re:  Abbreviated 510(k) Notification 
[Brand Name] Male Latex Condom 
Dear Sir or Madam: 
This submission is being made in compliance with Section 510(k) of the Food, Drug and Cosmetic Act as 
amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990 and the Food 
and Drug Administration Modernization Act of 1997, and the Office of Device Evaluation guidance for 
Abbreviated 510(k) requirements for a male latex condom.  The enclosed information is being submitted 
for the [Brand Name] Male Latex Condom, which is made from Natural Rubber Latex.  Two copies of this 
Premarket Notification are being submitted in accordance with 21 CFR 807. 
The purpose of this submission is to notify FDA, in accordance with the 510(k) provisions of the Act, of 
our intent to introduce this [new product, the... /or/ modification of the currently marketed]  [Brand Name] 
Male Condom into commercial distribution. 
If you have any questions regarding this submission, please telephone [contact persons name] at [(area) 
phone number]. 
Sincerely yours, 
[signature] 
[Name] 
[Title]  Abbreviated 510(k) for Male Latex Condoms  Page 5 of 16 
PREMARKET NOTIFICATION 

TRUTHFUL AND ACCURATE STATEMENT 

[Refer to 807.85(j)] 
I certify, in my capacity as [Title], that I believe, to the best of my knowledge, 
that  all  data  and  information  submitted  in  this  510(k)  Premarket  Notification 
Submission is truthful and accurate and that no material fact has been omitted. 
[signature] 
....................................... 
[Name] 
[Title] 
[date] 
.......................................
 Date  Abbreviated 510(k) for Male Latex Condoms 	 Page 6 of 16 
I.	  GENERAL INFORMATION 
A.	  Submitter's Name and Address 
[Company Name] 
[P.O. Box & Street Address] 

[City, State, ZIP] 

B. 	 Contact Person 
[Name]
 
[Title]
 
[Phone]
 
[Fax]
 
C.	  Establishment Registration Number of Submitter 
[Number] 
D.	  Contract Manufacturing Facility 
[Company Name & Address] 

Establishment Registration: [Number]
 
E.	  Device Name 

Proprietary Name: 

Common Name: 

Classification Name: 

F.	  Device Classification 
Class II 884.5300 and/or 884.5310 (Condom with spermicidal lubricant) 
G.	  Action Taken to Comply with Section 514 of the Act 
The  Agency  has  recognized  the  ASTM  Standard  Specifications  for  Rubber 
Contraceptives (Condoms), D3492, and the ISO standard 10993: Biological Evaluation of 
Medical Devices.  Conformance or variance with these standards is described on the 
following pages. 
H. 	 Reason for 510(k) Submission 
  Initial Product Introduction 
  New Model for Product-line Extension 
  Initial Import into the USA 
  Other (Include in Part IV an explanation referenced to Part I.H.) 
I.	  Predicate Device 
[Brand Name of Predicate Device] 

[Company Name] 

510(k) Document Control Number [K######]
  Abbreviated 510(k) for Male Latex Condoms 	 Page 7 of 16 
NOTE: 	 Provide the information required by 21 CFR 807.92,
 Content and format for a 510(k) summary (Option 1), below 
  OR
 the 510(k) Statement (Option 2) on the next page. 
II.   510(k) SUMMARY (Option 1) 
[Refer to 21 CFR 807.92] 
Submitted by: 	 [Company]
 
[Division]
 
[P.O. Box / Street Address]
 
[City, State Zip]
 
[Phone]
 
Contact Person:	  [Individuals Name] 
Date Prepared:	  [Date] 
Proprietary Name:	  [Brand Name of Condom] 
Common Name:	  Latex Condom 
Classification Name:	  Condom (21 CFR 884.5300) 
and / or 
Condom with Spermicidal Lubricant (21 CFR 884.5310) 
Predicate Device:  Latex Lubricated Condom 

510(k) #K[######]
 
and / or
 
Latex Condom with Spermicidal Lubricant 
510(k) #K[######] 
Description of the Device: This condom is made of a natural rubber latex sheath, which 
completely covers the penis with a closely fitted membrane. This condom [include a brief 
description of the condom, such as, a straight-walled, nipple-end, nominal length, nominal 
width, nominal thickness, etc]. 
Intended Use of the Device: This latex condom has the same intended use as the predicate 
condom. The condom is used for contraception and for prophylactic purposes (to help 
prevent pregnancy and the transmission of sexually transmitted diseases.) 
Technological Characteristics: [Indicate whether the condom has the same technological 
characteristics as the predicate condom identified above. Indicate that the design is in 
conformance with ASTM Latex Condom Standard D3492 and that the condom is made of 
natural rubber latex. Summarize the similarities and differences of the features and 
technological characteristics of the condom in comparison to the predicate condom.]  Abbreviated 510(k) for Male Latex Condoms  Page 8 of 16 
II.  510(k) STATEMENT (Option 2) 
[Refer to 807.93] 
I certify that, in my capacity as (the position held in company by person 
required to submit the premarket notification, preferably the official 
correspondent in the firm), of (company name), I will make available all 
information included in this premarket notification on safety and effectiveness 
within 30 days of request by any person if the device described in the premarket 
notification submission is determined to be substantially equivalent.  The 
information I agree to make available will be a duplicate of the premarket 
notification submission, including any adverse safety and effectiveness 
information, but excluding all patient identifiers, and trade secret and 
confidential commercial information, as defined in 21 CFR 20.61. 
. 
Certified:  ________[Signed]________________ 
_________[Date]_________________  Abbreviated 510(k) for Male Latex Condoms 	 Page 9 of 16 
III.  DECLARATION of CONFORMANCE with CONSENSUS STANDARDS 
A.   The condom intended to be introduced conforms in all respects with the 
requirements of the current edition of ASTM* Standard Specification for Rubber 
Contraceptives (Male Condoms), D3492, except as noted at variance: 
Requirement*	  SO STIPULATED    AT VARIANCE   
1.	   Manufactured from good quality natural rubber  1.          
latex.(ammoniated), conforming to Specification 
ASTM D 1076-97 
2.	   Meets criteria that toxic, sensitizing, locally  2.          
irritating, or otherwise harmful substances are 
not released or liberated 
3.	   Minimum length is 160 mm  3.          
4.	   Maximum width is 54 mm  4.          
5.	   Minimum thickness is 0.03 mm  5.          
6.	   Air Burst Test Pressure  6.          
7.	   Air Burst Test Volume  7.          
8.	   Leakage AQL  8.          
9.	   Package integrity AQL  9.          
B.   The condom intended to be introduced has been tested in conformance with the 
following test methods of ISO 10993 Biological Evaluation of Medical Devices 
and ODE Guidance Memorandum G95-1 dated May 1, 1995, for a Device in 
Contact for 24 hours or less with a Skin/Mucosal Membrane Surface, except as 
noted at variance.  When evaluated according to this standard, the condom is 
not toxic (local or systemic), sensitizing, locally irritating or otherwise harmful. 
Requirement*	  SO STIPULATED    AT VARIANCE   
1.	   ISO 10993-5  Cytotoxicity  1.          
2.	   ISO 10993-10  Irritation and Sensitization  2.          
3.	   ISO 10993-11  Systemic Toxicity  3.          
4.	   ISO 10993-12  Sample Preparation and  4.          
Reference Materials 
The ISO 10993 standard describes test methods, but does not specify performance 
limits for each test.  Therefore, data summaries and results of the above safety 
testing are included in Part IV. 
*	  ASTM  American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428; 
(610) 832-9500. Refer to full text of ASTM D3492 for the specific requirements that apply. 
	  Certifying signature required on  next page of this Part. 
	  Include (under a separate section, identified with the item number) information, data, and analyses appropriately 
describing and explaining variance from standard; include rationale for variance and justification why this 
variance does not have a material impact on the substantial equivalence of the condom.  Information for a Male Latex Condom 510(k) Submission 	 Page 10 of 16 
III.  DECLARATION of CONFORMANCE with CONSENSUS STANDARDS 
(continued) 
C.	  This device is certified to comply with the voluntary standards as contained in ASTM D3492 
[insert edition date] and ISO 10993 [insert edition date], as specified and so stipulated above, 
unless and where specifically so indicated to be at variance with the standard specification, in 
which case information, data, and analysis, or justification for non-applicability, are provided to 
fully describe the variance and its impact on the device and to justify said variance. 
[signature] 
[Name] 
[Title] 
[Date]
 Date 
When there is a third-party certifying laboratory or certification body, provide the names and addresses and 
a reference to any accreditation of each laboratory. Certification statements should also be included.  Information for a Male Latex Condom 510(k) Submission 	 Page 11 of 16 
IV.  DESCRIPTION OF DEVICE 
A.	   Description of the Device: This condom is made of a natural rubber latex sheath, which 
completely covers the penis with a closely fitted membrane. This condom [include a diagram(s) 
and a brief description of the condom, such as, a straight-walled, nipple-end, nominal length, 
nominal width, nominal thickness, dusting powder, lubricant systems, and other specifications. If 
a color additive is used, include a citation to the FDA Color Listing Regulation for the color and 
the Color Index Number].  See example, Tabs 1 and 2. 
 
B.  	 Proprietary and Confidential Compounded Latex Formulation: [Provide a listing of the 
component ingredients and the range of quantities used in the preparation of the compounded 
latex.] See example, Tab 2. 
 
C.	   Summary Reports of Safety Testing Results: [Provide a summary of the results obtained from the 
cytotoxicity, irritation and sensitization, and systemic toxicity testing as stipulated under Part III B 
above. See ODE Guidance Memoranda G95-1, May 1, 1995.] 
V.  STATEMENT OF SUBSTANTIAL EQUIVALENCE 
Indicate whether the condom has the same intended use and technological characteristics as the 
predicate condom. Summarize the similarities and differences of the features and technological 
characteristics of the condom in comparison to the predicate condom.  Information for a Male Latex Condom 510(k) Submission 	 Page 12 of 16 
VI.  LABELS, LABELING AND ADVERTISEMENTS 
Provide proposed labels, labeling and advertisements sufficient to describe the device, its intended 
use, and the directions for use. (21 CFR 807.87(e))  For overall labeling guidance, manufacturers 
are encouraged to consult with FDA's manual "Labeling:  Regulatory Requirements for Medical 
Devices, (HHS Publication FDA 89-4203).   (Also see Title 21 CFR 801, 801.435 and 
801.437.) Labeling for latex condoms should include but not be limited to the following: 
A.	  Statement of Identity and Intended Use 
1. 	  The principal display panel as defined in 21 CFR 801.60 and primary package (individual 
condom packet) should identify the device as a male LATEX condom. 
 
2. 	  The principal display panel and primary package should identify the intended use for male 
condoms, i.e., contraception. 
 
3. 	  The principal display panel, and primary package (individual condom packet) should also 
include the following statement: 
 
If used properly, latex condoms will help to reduce the risk of transmission 
of HIV infection (AIDS) and many other sexually transmitted diseases. 
The following expanded statement should be added to the package insert, directions for use: 
If used properly, latex condoms will help to reduce the risk of transmission 
of HIV infection (AIDS) and many other sexually transmitted diseases, 
including chlamydia infections, genital herpes, genital warts, gonorrhea, 
hepatitis B, and syphilis. 
4.	  Special labeling is required for condoms lubricated with a spermicidal lubricant. The 
principal display panel, primary package and any package insert must prominently and 
conspicuously bear a specific contraceptive effectiveness cautionary provision: 
This product combines a latex condom and a spermicidal lubricant.  The 
spermicide, nonoxynol-9, reduces the number of active sperm, thereby 
decreasing the risk of pregnancy if some semen spills or seeps outside the 
condom.  However, the extent of decreased risk has not been established. 
This condom should not be used as a substitute for the combined use of a 
vaginal spermicide and a condom. 
B.  	 The package insert for latex condoms should contain a contraceptive effectiveness table with 
pregnancy rates for all drug and device contraceptives. This information will enable contraceptive 
users to compare their contraceptive to alternatives and make appropriate choices. FDA has 
developed such a table entitled "Pregnancy Rates for Birth Control Methods," that can be used for 
this purpose. This table is the result of an intra-agency effort that included focus studies funded 
by FDAs Office of Womens Health.  Data for this table comes from Contraceptive Technology, 
17th ed., Hatcher et al., and will be updated periodically as new data becomes available. 
 
 See ODE guidance entitled "Uniform Contraceptive Labeling:  Guidance To Industry." 
  Information for a Male Latex Condom 510(k) Submission 	 Page 13 of 16 
VI.  LABELS, LABELING AND ADVERTISEMENTS 
(continued) 
C. 	  The Center has issued specific guidance that established the intended use and suggested directions 
for use for male latex condoms. This guidance provides acceptable and appropriate labeling. The 
following are suggested precautions and directions for use: 
Precautions 
 	  Use a new condom every time you have sexual intercourse or other acts between 
partners that involve contact with the penis. 
 	  Do Not Reuse Condoms. 
 	  Store condoms in a cool, dry place. 
 	  If the rubber material is sticky or brittle or obviously damaged, do not use it. 
 	  If a lubricant is wanted, use water-based lubricants such as [name of product]. DO NOT 
USE OIL-BASED LUBRICANTS, such as those made with petroleum jelly (e.g., 
Vaseline), mineral oil, vegetable oil, or cold cream, as these may damage the condom. 
Directions for Use 
 	  Put the condom on after the penis is fully erect and before intimate contact. Lesions, pre
ejaculate secretions, semen, vaginal secretions, saliva, urine, and feces can all transmit 
disease organisms. 
 
 	  Place the condom on the head of the penis and unroll or pull it all the way to the base. 
 	  Leave an empty space at the end of the condom to collect semen. Remove any air 
remaining in the tip of the condom by gently pressing the air out toward the base of the 
penis. 
 	  After ejaculation and while the penis is still erect, hold onto the rim of the condom so 
that the condom does not slip off as the penis is carefully withdrawn. 
D. 	 The retail and primary package (individual condom packet) must include an expiration date. (See 
21 CFR 801.435, User labeling for latex condom, effective March 25, 1998.) 
 
E. 	  On September 30, 1997, FDA published a Final Rule (62 FR 51021-51030, 1997), codified at 21 
CFR 801.437, which will require all medical device products composed of or containing, natural 
rubber latex and which contact humans, such as latex condoms, to bear the following statement in 
bold print on the device labeling, in conformance with Section 502(c) of the Act: 
CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX 
WHICH MAY CAUSE ALLERGIC REACTIONS 
This statement must appear on all device labels, and other labeling, and shall appear on the 
principal display panel of the device packaging, the outside package, container or wrapper, and the 
immediate device package, container or wrapper. This final rule has an effective date of 
September 30, 1998. This labeling requirement is considered necessary because devices 
composed of, or containing, natural rubber latex, pose a significant health risk to some individuals. 
(See also, FDA's March 29, 1991, FDA Medical Alert, Allergic Reactions to Latex-Containing 
Medical Devices. MDA91-1.)  Information for a Male Latex Condom 510(k) Submission 	 Page 14 of 16
 VII.  INDICATIONS FOR USE STATEMENT 
510(k) Number:	  (if known) 
Device Name:	  [Brand Name] Male Natural Rubber Latex Condom 
Indications For Use:	  The [Brand Name] condom is used for contraception and for 
prophylactic purposes (to help prevent pregnancy and the 
transmission of sexually transmitted diseases). 
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 
Concurrence of CDRH, Office of Device Evaluation (ODE) 
Prescription Use  	                        OR        Over-The-Counter Use____________                            
(Per 21 CFR 801.109)  Information for a Male Latex Condom 510(k) Submission  Page 15 of 16 
Tab 1 - Device Description 
Provide a diagram (or diagrams) of  the subject latex condom.  The diagram should show key 
dimensions, as well as relevant contours. 
Provide all relevant product specifications that adequately characterize the condom.  Given 
below is an example of how this information should be given. 
Typical (Average) Product Characteristics 
   Nominal length (mm) 
   Nominal width (mm) 
   Nominal thickness (mm) 
   Air burst test pressure 
   Air burst test volume 
   Materials of the primary package (individual condom packet) 
   Lubricant system (include viscosity)  Information for a Male Latex Condom 510(k) Submission  Page 16 of 16 
Tab 2 - Compounded Latex Formulation 
Provide a complete summary of the compounded latex formulation and other materials used 
in the manufacture of the condom.  Given below is an example to illustrate how this 
information should be given. 
TABLE 1 - Compounded Latex Formulation Summary 
GENERIC NAME & CHEMICAL COMPOSITION  CAS NO  PERCENTAGE  FUNCTION 
RANGE 
PPH 
LATEX 
Natural Rubber Latex (cis-1,4-polyisoprene)  100.00 
Diisopropyl xanthogen polysulfide  - Vulcanizing agent (cross-linking) 
Sulfur  - Vulcanizing agent (cross-linking) 
Zinc Oxide  - Activator 
Zinc-N-diethyl-dithio-carbomate  - Accelerator 
Zinc-N-dibutyl-dithio-carbomate  - Accelerator 
Potassium Hydroxide  - Stabilizing agent 
Sodium lauryl sulfate  - Emulsifier 
Naphthalene sulfonic acid-formaldehyde  - Emulsifier 
condensate, sodium salt 
Ammonia  Preservative 
Formaldehyde  Preservative 
- Antioxidant 
- Anti-ozonants 
TABLE 2 - Compounded Formulation Condom Additives 
GENERIC NAME & CHEMICAL COMPOSITION  SUPPLIER  CAS  NO.  AMOUNT (MG) 
DUSTING AGENTS 
U.S.P. Corn Starch 
LUBRICANTS 
Silicone (polydimethylsiloxane) 
Nonoxynol-9 
TABLE 3 - Condom Composition Summary - Colors 
COLOR  PIGMENT  C.I. NO.  CAS REG. NO.  21 CFR  AMOUNT 
CITATION  PPH 
LATEX 
Red  C.I. Pigment Red 48:2  C.I.#12490  73.100 
Permanent Carmine 
Blue  C.I. Pigment Blue 15:2/Copper  C.I. #74160  CAS Reg No.147-14-8  178.3297(e) 
Phthalocyanine Blue 
Green  C.I. Pigment Green 7/Polychloro  C.I. #74260  CAS Reg No.1328-53-6  178.3297(e) 
Copper Phthalocyanine Green 
Yellow  C.I. Pigment Yellow 74  C.I. #11741  CAS Reg No.6358-31-2  177.2600 
Azo Yellow