FDA 510(k)

SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)

K-Number: K010297 · 2001-02-16

Decision Date2001-02-16

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 2001-02-16 under 510(k) number K010297. 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 SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)?

SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) is a medical device that received FDA 510(k) clearance on 2001-02-16. The listed applicant is Maxxim Medical. The 510(k) number is K010297.

When did SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) receive FDA 510(k) clearance?

SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) received FDA 510(k) clearance on 2001-02-16, under 510(k) number K010297.

Who is the listed applicant for SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)?

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

What is the FDA product code for SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)?

The FDA product code for SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) is LZA.

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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.