FDA 510(k)

SUPERGLOVES POWDERED NITRILE

K-Number: K980966 · 1998-07-22

Decision Date1998-07-22

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SUPERGLOVES POWDERED NITRILE 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 1998-07-22 under 510(k) number K980966. 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 POWDERED NITRILE?

SUPERGLOVES POWDERED NITRILE is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Supermax Sdn Bhd. The 510(k) number is K980966.

When did SUPERGLOVES POWDERED NITRILE receive FDA 510(k) clearance?

SUPERGLOVES POWDERED NITRILE received FDA 510(k) clearance on 1998-07-22, under 510(k) number K980966.

Who is the listed applicant for SUPERGLOVES POWDERED NITRILE?

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 POWDERED NITRILE?

The FDA product code for SUPERGLOVES POWDERED NITRILE is LZA.

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Other records listing Supermax Sdn Bhd as applicant

K013774CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA K993865GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES K993864COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES K993258SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES K991415SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES K980494SUPERGLOVES

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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.