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FDA 510(k)

NEEDLESTICK PROTECTIVE GLOVE

K-Number: K905527 · 1991-03-22

ApplicantMedev Corp.
Decision Date1991-03-22
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLESTICK PROTECTIVE GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Medev Corp.. It received FDA 510(k) clearance on 1991-03-22 under 510(k) number K905527. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLESTICK PROTECTIVE GLOVE?

NEEDLESTICK PROTECTIVE GLOVE is a medical device that received FDA 510(k) clearance on 1991-03-22. The listed applicant is Medev Corp.. The 510(k) number is K905527.

When did NEEDLESTICK PROTECTIVE GLOVE receive FDA 510(k) clearance?

NEEDLESTICK PROTECTIVE GLOVE received FDA 510(k) clearance on 1991-03-22, under 510(k) number K905527.

Who is the listed applicant for NEEDLESTICK PROTECTIVE GLOVE?

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

What is the FDA product code for NEEDLESTICK PROTECTIVE GLOVE?

The FDA product code for NEEDLESTICK PROTECTIVE GLOVE is LZC.

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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.

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