FDA 510(k)

SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE

K-Number: K022146 · 2002-09-03

ApplicantSyntex Healthcare Products Co., Ltd.

Decision Date2002-09-03

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Healthcare Products Co., Ltd.. It received FDA 510(k) clearance on 2002-09-03 under 510(k) number K022146. 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 SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE?

SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2002-09-03. The listed applicant is Syntex Healthcare Products Co., Ltd.. The 510(k) number is K022146.

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

SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 2002-09-03, under 510(k) number K022146.

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

The FDA 510(k) record lists Syntex Healthcare Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE?

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

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Other records listing Syntex Healthcare Products Co., Ltd. as applicant

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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.