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FDA 510(k)

Gammex Cut-Resistant Glove Liner

K-Number: K160974 · 2016-10-28

Decision Date2016-10-28
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gammex Cut-Resistant Glove Liner 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 2016-10-28 under 510(k) 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. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K160974.

When did Gammex Cut-Resistant Glove Liner receive FDA 510(k) clearance?

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

Who is the listed applicant for Gammex Cut-Resistant Glove Liner?

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 Gammex Cut-Resistant Glove Liner?

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

Other records listing Ansell Healthcare Products, LLC as applicant

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.

View all 14 devices →

Related Devices (Code: KGO)

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.

Official Source

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