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FDA 510(k)

COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)

K-Number: K936295 · 1995-02-24

ApplicantWembley Rubber Products
Decision Date1995-02-24
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) is the device name listed in this FDA 510(k) record. The listed applicant is Wembley Rubber Products. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K936295. 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 BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)?

COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Wembley Rubber Products. The 510(k) number is K936295.

When did COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) receive FDA 510(k) clearance?

COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) received FDA 510(k) clearance on 1995-02-24, under 510(k) number K936295.

Who is the listed applicant for COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)?

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

What is the FDA product code for COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)?

The FDA product code for COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) is LYY.

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK230573Powder 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 BhdK223298Sterile 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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