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FDA 510(k)

Skyn Original Polyisoprene Lubricated Male Condom - Flavored

K-Number: K171172 · 2017-08-02

ApplicantAnsell Healthcare Products, LLC
Decision Date2017-08-02
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-08-02 under approval number K171172. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is a medical device that received FDA 510(k) clearance on 2017-08-02. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K171172.

When was Skyn Original Polyisoprene Lubricated Male Condom - Flavored approved by the FDA?

Skyn Original Polyisoprene Lubricated Male Condom - Flavored received FDA 510(k) clearance on 2017-08-02, under approval number K171172.

What company makes Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

The FDA product code for Skyn Original Polyisoprene Lubricated Male Condom - Flavored is MOL.

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Related Devices (Code: MOL)

K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC K171639Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC K203541Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc. K23190845 Micron Polyisoprene CondomSuretex Limited K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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