Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Skyn Original Polyisoprene Lubricated Male Condom

K-Number: K160399 · 2016-07-25

ApplicantAnsell Healthcare Products, LLC
Decision Date2016-07-25
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Skyn Original Polyisoprene Lubricated Male Condom is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2016-07-25 under approval number K160399. 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?

Skyn Original Polyisoprene Lubricated Male Condom is a medical device that received FDA 510(k) clearance on 2016-07-25. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K160399.

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

Skyn Original Polyisoprene Lubricated Male Condom received FDA 510(k) clearance on 2016-07-25, under approval number K160399.

What company makes Skyn Original Polyisoprene Lubricated Male Condom?

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

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

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

Other Devices by Ansell Healthcare Products, LLC

K160974Gammex Cut-Resistant Glove Liner K151694Gammex PI Hybrid Surgical Gloves K171737Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves K171172Skyn Original Polyisoprene Lubricated Male Condom - Flavored K163107Lifestyles Zero Lubricated Latex Male Condom K171375Gammex PI Breach Detect Powder Free Surgical Glove

View all 14 devices →

Related Devices (Code: MOL)

K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell 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.

↑