FDA 510(k)

COMFIT STERILE LATEX EXAMINATION GLOVE

K-Number: K922513 · 1992-08-20

ApplicantWembley Rubber Products (M) Sdn Bhd

Decision Date1992-08-20

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

COMFIT STERILE LATEX EXAMINATION GLOVE 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 1992-08-20 under 510(k) number K922513. 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 STERILE LATEX EXAMINATION GLOVE?

COMFIT STERILE LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1992-08-20. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K922513.

When did COMFIT STERILE LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

COMFIT STERILE LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1992-08-20, under 510(k) number K922513.

Who is the listed applicant for COMFIT STERILE LATEX EXAMINATION GLOVE?

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 STERILE LATEX EXAMINATION GLOVE?

The FDA product code for COMFIT STERILE LATEX EXAMINATION GLOVE 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)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.