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SKORE Smooth Condoms - SKORE (Colors & Flavors)

TTK HEALTHCARE LIMITED · Model SKORE Banana · UDI-DI 08906007135191

HIS

510(k) clearances

408

Adverse events (3 deaths)

Recalls

Facilities

Description

The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, smooth, teat ended, yellow colored, banana flavored 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 Smooth Condoms - SKORE (Colors & Flavors) 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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Data 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.