FDA 510(k)

POWDERFREE LATEX EXAMINATION GLOVES

K-Number: K980167 · 1998-03-13

Decision Date1998-03-13

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERFREE LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Besglove Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K980167. 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 POWDERFREE LATEX EXAMINATION GLOVES?

POWDERFREE LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Besglove Medicare Sdn. Bhd.. The 510(k) number is K980167.

When did POWDERFREE LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDERFREE LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1998-03-13, under 510(k) number K980167.

Who is the listed applicant for POWDERFREE LATEX EXAMINATION GLOVES?

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

What is the FDA product code for POWDERFREE LATEX EXAMINATION GLOVES?

The FDA product code for POWDERFREE LATEX EXAMINATION GLOVES is LYY.

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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.

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Other records listing Besglove Medicare Sdn. Bhd. as applicant

K994082POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)K993500POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)K993502POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)K993495POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)K981877NITRILE POWDERFREE EXAMINATION GLOVES K982286POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)

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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.