FDA 510(k)

LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING

K-Number: K973664 · 1998-03-13

ApplicantEvergrade Healthcare Products Sdn Bhd

Decision Date1998-03-13

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING is the device name listed in this FDA 510(k) record. The listed applicant is Evergrade Healthcare Products Sdn Bhd. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K973664. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING?

LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Evergrade Healthcare Products Sdn Bhd. The 510(k) number is K973664.

When did LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING receive FDA 510(k) clearance?

LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING received FDA 510(k) clearance on 1998-03-13, under 510(k) number K973664.

Who is the listed applicant for LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING?

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

What is the FDA product code for LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING?

The FDA product code for LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING is LYY.

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Other records listing Evergrade Healthcare Products Sdn Bhd as applicant

K942855NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES K932116PATIENT EXAMINATION GLOVES (POWDER FREE)

Related Devices (Code: LYY)

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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.