| ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| Recognition Number | ObGyn/Gastroenterology/Urology |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 9-67 |
| 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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies
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.
| 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 |
| There is no relevant guidance developed at this time. |