ASTM D7661-10 (Reapproved 2017)

Standard Test Method For Determining Compatibility Of Personal Lubricants With Natural Rubber Latex Condoms

D7661-10 (Reapproved 2017)

Standard Organization: ASTM

ASTM D7661-10 (Reapproved 2017)
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Recognition NumberObGyn/Gastroenterology/Urology
Recognition Date2018-09-17
Recognition List050
Recognition Number9-67
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG ObGyn/Gastroenterology/Urology
FDA Tech  Sharon Andrews   FDA/OMPT/CDRH/ODE/DRGUD/OGDB/   301-796-6529   sharon.andrews@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies

Scope:

This test method covers procedures used to detect a shiftin physical properties of non-lubricated natural rubber latex(NRL) condoms after immersion in a personal lubricant."Personal lubricants" are lubricants such as liquids or gels thatare applied by the consumer at the time of condom use.

Code of Federal Regulations:

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
§884.5340 Single-Use Internal Condom Class 2 MBU

FDA Guidance:

There is no relevant guidance developed at this time.


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