FDA 510(k)

MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS

K-Number: K000985 · 2000-04-24

Decision Date2000-04-24

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS is the device name listed in this FDA 510(k) record. The listed applicant is Matang Mfg. Sdn. Bhd.. It received FDA 510(k) clearance on 2000-04-24 under 510(k) number K000985. 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 MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS?

MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS is a medical device that received FDA 510(k) clearance on 2000-04-24. The listed applicant is Matang Mfg. Sdn. Bhd.. The 510(k) number is K000985.

When did MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS receive FDA 510(k) clearance?

MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS received FDA 510(k) clearance on 2000-04-24, under 510(k) number K000985.

Who is the listed applicant for MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS?

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

What is the FDA product code for MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS?

The FDA product code for MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS is LYY.

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Other records listing Matang Mfg. Sdn. Bhd. as applicant

K122131POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)K121368NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)K072614MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE K032549MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES K012558POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS K982877MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE

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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.