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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 FR Publication Date 01/30/2014 
FR Recognition Number 9-67
Standard
ASTM D7661-10
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§884.5310 Condom With Nonoxynol-9 Class 2 LTZ
§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
Unclassified Condom, Female, Single-Use Class 3 MBU
FDA Technical Contact
 Sharon Andrews
  FDA/OMPT/CDRH/ODE/DRGUD/OGDB/
  301-796-6529
  sharon.andrews@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
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