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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 9-56: ASTM D3492-08, standard specification for rubber contraceptives (male condoms). (ObGyn/Gastroenterology)

Date of Standard: 2008. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(3)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Natural Rubber Latex Condoms and Natural Rubber Latex Condoms with Spermicidal Lubricant
Processes Affected:
510(k), IDE, Design Control Input, QSR, Surveillance testing (water leakage)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard with the following exception:

Table 2 Dimensional Requirements is not recognized.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§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 Notification: 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
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G202
  Silver Spring MD 20993
  301/796-6533
  email: elaine.blyskun@fda.hhs.gov
 Sharon Andrews
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G110
  Silver Spring MD 20993
  301/796-6529
  email: sharon.andrews@fda.hhs.gov
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