Skyn Original Polyisoprene Lubricated Male Condom - Flavored

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K171172 ↗

FDA Product Code

MOL

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ansell Healthcare Products LLC →

• What material is the Skyn Original condom made from and why is it chosen?

  It is made from synthetic polyisoprene, which mimics the elasticity of latex while reducing the risk of latex allergy. Polyisoprene provides a strong, thin barrier that maintains comfort and reliable protection during intercourse.

• How is the condom supplied and what features does it include?

  The condom is supplied sterile, in a single‑use package. Each unit includes a lubricated sheath, an integral ring at the open end to aid placement, and a reservoir tip at the closed end to collect semen, helping to prevent breakage and improve safety.

• Is the flavored version intended for any different use than the standard condom?

  The flavored variant is intended for the same over‑the‑counter, single‑use contraception and STI prophylaxis as the standard model. The flavor is added solely for user preference and does not alter the device’s protective performance.

• What regulatory classification does this condom have and what does that mean for clinicians?

  It is classified as a Class II medical device under FDA 510(k) clearance (product code MOL). This classification indicates that the device is considered moderate risk and must meet specific performance standards, providing clinicians with assurance of its safety and efficacy when used as directed.