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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 9-82: ISO 4074 First edition 2002-12-01, natural latex rubber condoms - requirements and test methods [including: technical corrigendum 1 (2002) & technical corrigendum 2 (2002)]. (ObGyn/Gastroenterology)

Date of Standard: 2002. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Latex Condoms and Latex Condoms with Spermicidal Lubricant
Processes Affected:
510(k), Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Clause 5.3 Dimensions and Annex L.3 Testing for holes, Electrical test are not recognized.
Related CFR Citations and Product Codes:
Device Name Device
§884.5300 Condom Class 2 HIS
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
Relevant Guidance:
Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions (July 23, 1998)

Compliance Policy Guide and FDA Test Methods (Sub Chapter 345 Obstetrics and Gynecology Sec. 345.100 Condoms; Defects- Criteria for Direct Reference Seizure (CPG 7124.21) Revised March 1995.

Guidance for Industry and FDA Staff Surveillance and Detention without Physical Examination of Condoms Document issued on: July 11, 2008

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300. Document issued December 23, 2008

Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide Document issued on: January 5, 2009

Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry Document issued on April 1, 2003
FDA Technical Contacts:
 Elaine Blyskun
  10903 New Hampshire Avenue Building 66, Room G202
  Silver Spring MD 20993
  email: elaine.blyskun@fda.hhs.gov
 Sharon Andrews
  10903 New Hampshire Avenue Building 66, Room G110
  Silver Spring MD 20993
  email: sharon.andrews@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036