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FDA 510(k)

JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING

K-Number: K964845 · 1997-02-27

ApplicantJinhua Latex Products Factory
Decision Date1997-02-27
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING is the device name listed in this FDA 510(k) record. The listed applicant is Jinhua Latex Products Factory. It received FDA 510(k) clearance on 1997-02-27 under 510(k) number K964845. 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 JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING?

JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING is a medical device that received FDA 510(k) clearance on 1997-02-27. The listed applicant is Jinhua Latex Products Factory. The 510(k) number is K964845.

When did JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING receive FDA 510(k) clearance?

JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING received FDA 510(k) clearance on 1997-02-27, under 510(k) number K964845.

Who is the listed applicant for JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING?

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

What is the FDA product code for JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING?

The FDA product code for JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING 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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