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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 the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-08-02 under 510(k) 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. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171172.

When did Skyn Original Polyisoprene Lubricated Male Condom - Flavored receive FDA 510(k) clearance?

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

Who is the listed applicant for Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ansell Healthcare Products, LLC as applicant

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Related Devices (Code: MOL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLCK240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited

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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