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SKORE Natural
TTK HEALTHCARE LIMITED · Model SKORE Natural · UDI-DI 08906007135757
1
510(k) clearances
408
Adverse events (3 deaths)
7
Recalls
77
Facilities
Description
The SKORE Natural condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE NATURAL natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-26 | GOLD STAR DISTRIBUTION INC | Potential exposure of rodents and rodent activity in the distribution center. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2016-11-22 | Reckitt Benckiser LLC | Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine. |
| 2013-01-14 | Ansell Healthcare Products LLC | Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards req |
| 2012-11-05 | Ansell Healthcare Products LLC | One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. |
| 2007-09-11 | Global Protection Corp. | Condoms fail the water leak test and package integrity |
| 2002-11-25 | Ansell Healthcare Inc | The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.