Recognized standard
D7661-10 (Reapproved 2017)
FDA recognition 9-67 · ASTM · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-67 |
|---|---|
| Designation | D7661-10 (Reapproved 2017) |
| Title | Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| Standards developer | ASTM International |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | 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. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: