FDA 510(k)

SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES

K-Number: K993258 · 1999-10-27

Decision Date1999-10-27

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Supermax Sdn Bhd. It received FDA 510(k) clearance on 1999-10-27 under 510(k) number K993258. 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 SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES?

SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Supermax Sdn Bhd. The 510(k) number is K993258.

When did SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1999-10-27, under 510(k) number K993258.

Who is the listed applicant for SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES?

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

What is the FDA product code for SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES?

The FDA product code for SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Supermax Sdn Bhd as applicant

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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.