FDA 510(k)

POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE

K-Number: K983721 · 1998-12-07

ApplicantKossan Latex Industries(M)Sdn Bhd

Decision Date1998-12-07

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Kossan Latex Industries(M)Sdn Bhd. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K983721. 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 PATIENT EXAMINATION GLOVE?

POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Kossan Latex Industries(M)Sdn Bhd. The 510(k) number is K983721.

When did POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE receive FDA 510(k) clearance?

POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983721.

Who is the listed applicant for POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE?

The FDA 510(k) record lists Kossan Latex Industries(M)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 PATIENT EXAMINATION GLOVE?

The FDA product code for POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE is LYY.

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Other records listing Kossan Latex Industries(M)Sdn Bhd as applicant

K123749POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE K120066POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL K111772POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE K062764POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED K062965CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM K060775POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF

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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.