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FDA 510(k)

POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI

K-Number: K992870 · 1999-10-15

ApplicantAlliance Rubber Products Sdn. Bhd.
Decision Date1999-10-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 1999-10-15 under 510(k) number K992870. 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 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI?

POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI is a medical device that received FDA 510(k) clearance on 1999-10-15. The listed applicant is Alliance Rubber Products Sdn. Bhd.. The 510(k) number is K992870.

When did POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI receive FDA 510(k) clearance?

POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI received FDA 510(k) clearance on 1999-10-15, under 510(k) number K992870.

Who is the listed applicant for POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI?

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

What is the FDA product code for POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI?

The FDA product code for POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI is LYY.

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Other records listing Alliance Rubber Products Sdn. Bhd. as applicant

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.

K002701POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)K991981NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLORK990427ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREEK990485NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLORK990486NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.K990453NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR

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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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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