Skyn Original Polyisoprene Lubricated Male Condom
FDA 510(k) clearance K160399 · decided 2016-07-25
Clearance details
- K-number
- K160399
- Device name
- Skyn Original Polyisoprene Lubricated Male Condom
- Applicant
- Ansell Healthcare Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-02-12
- Decision date
- 2016-07-25
- Days to decision
- 164 days
- Clearance type
- Abbreviated
- Product code
- MOL
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, S recall (Z-1530-2022) | Family Dollar Stores, Llc. | 2022-08-17 |