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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 9-43: ISO 16038 First edition 2005-11-01, rubber condoms -- guidance on the use of iso 4074 in the quality management of natural rubber latex condoms. (ObGyn/Gastroenterology/Urology)

Date of Standard: 2005. 
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
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.

FDA Laboratory Information Bulletion #3970. Issued July 1995

Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex

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
FDA Technical Contact:
 Sharon Andrews
  10903 New Hampshire Avenue WO66, RMG110
  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