Recognition List Number: 027 Publication Date: 08/02/2011
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 Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD) |
|
| (2) | OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
|
| (3) | OFFICE OF COMPLIANCE (OC) |
|
|
| 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
Note: Manufacturers should be prepared to justify a drop of >10% for any of the measured condom properties. (Calculation described in Section 11.)
Note: The results of the testing per this Standard will affect lubricant labeling with respect to condom use.
Note: Although this Standard is directed towards compatibility of personal lubricants and non-lubricated natural rubber latex male condoms, FDA encourages manufacturers to adapt this Standard to evaluate personal lubricant compatibility with pre-lubricated natural rubber latex male condoms, synthetic male condoms, male condoms with nonoxynol-9, male condoms with microbicides, and female condoms, as standardized methods do not currently exist to evaluate personal lubricant compatibility with these other condom types. Manufacturers are welcome to share their test methodology with FDA for comment. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5330 |
Condom, Female, Single-Use |
Class 3 |
MBU |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5300 |
Condom |
Class 2 |
HIS |
| §884.5300 |
Condom, Synthetic |
Class 2 |
MOL |
| §884.5300 |
Lubricant, Personal |
Class 2 |
NUC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5310 |
Condom With Nonoxynol-9 |
Class 2 |
LTZ |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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 |
|
|
