FDA 510(k)

SAFESKIN

K-Number: K962139 · 1996-12-19

Decision Date1996-12-19

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFESKIN is the device name listed in this FDA 510(k) record. The listed applicant is Safeskin Corp.. It received FDA 510(k) clearance on 1996-12-19 under 510(k) number K962139. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFESKIN?

SAFESKIN is a medical device that received FDA 510(k) clearance on 1996-12-19. The listed applicant is Safeskin Corp.. The 510(k) number is K962139.

When did SAFESKIN receive FDA 510(k) clearance?

SAFESKIN received FDA 510(k) clearance on 1996-12-19, under 510(k) number K962139.

Who is the listed applicant for SAFESKIN?

The FDA 510(k) record lists Safeskin Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFESKIN?

The FDA product code for SAFESKIN is LZA.

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Other records listing Safeskin Corp. as applicant

K993117SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG K994081SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES K992830SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE K992210SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES K992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM K992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES

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Related Devices (Code: LZA)

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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.