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FDA 510(k)

Gammex Cut-Resistant Glove Liner

K-Number: K160974 · 2016-10-28

ApplicantAnsell Healthcare Products, LLC
Decision Date2016-10-28
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gammex Cut-Resistant Glove Liner is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2016-10-28 under approval number K160974. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gammex Cut-Resistant Glove Liner?

Gammex Cut-Resistant Glove Liner is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K160974.

When was Gammex Cut-Resistant Glove Liner approved by the FDA?

Gammex Cut-Resistant Glove Liner received FDA 510(k) clearance on 2016-10-28, under approval number K160974.

What company makes Gammex Cut-Resistant Glove Liner?

Gammex Cut-Resistant Glove Liner is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Gammex Cut-Resistant Glove Liner?

The FDA product code for Gammex Cut-Resistant Glove Liner is KGO.

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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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