FDA 510(k)

COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

K-Number: K962189 · 1996-07-26

ApplicantWembley Rubber Products (M) Sdn Bhd

Decision Date1996-07-26

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) is the device name listed in this FDA 510(k) record. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1996-07-26 under 510(k) number K962189. 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 COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)?

COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) is a medical device that received FDA 510(k) clearance on 1996-07-26. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K962189.

When did COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) receive FDA 510(k) clearance?

COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) received FDA 510(k) clearance on 1996-07-26, under 510(k) number K962189.

Who is the listed applicant for COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)?

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

What is the FDA product code for COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)?

The FDA product code for COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) is LYY.

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Other records listing Wembley Rubber Products (M) Sdn Bhd as applicant

K982600PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)K972616ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)K953213COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)K962188COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

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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.