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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 9-67: ASTM D7661-10, standard test method for determining compatibility of personal lubricants with natural rubber latex condoms. (ObGyn/Gastroenterology)

Date of Standard: 2010. 
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 COMPLIANCE (OC)
(2)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD)
(3)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
Devices Affected:
Personal lubricants; Condoms
Processes Affected:
510(k), IDE, PMA, Design Control Input, QSR
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete Standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§884.5330 Condom, Female, Single-Use Class 3 MBU
§884.5300 Condom Class 2 HIS
§884.5300 Condom, Synthetic Class 2 MOL
§884.5300 Lubricant, Personal Class 2 NUC
§884.5300 Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Class 2 PEB
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
FDA Technical Contact:
 Donna L. Walsh
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2126
  Silver Spring MD 20993
  301/796-2498
  email: donna.walsh@fda.hhs.gov
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