FDA 510(k)

MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE

K-Number: K020837 · 2002-12-02

ApplicantShanghai Motex Healthcare Co., Ltd.

Decision Date2002-12-02

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Motex Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2002-12-02 under 510(k) number K020837. 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 MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE?

MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE is a medical device that received FDA 510(k) clearance on 2002-12-02. The listed applicant is Shanghai Motex Healthcare Co., Ltd.. The 510(k) number is K020837.

When did MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE receive FDA 510(k) clearance?

MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE received FDA 510(k) clearance on 2002-12-02, under 510(k) number K020837.

Who is the listed applicant for MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE?

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

What is the FDA product code for MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE?

The FDA product code for MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE is LYY.

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Other records listing Shanghai Motex Healthcare Co., Ltd. as applicant

K122557MOTEX POWDER-FREE NITRILE SURGICAL GLOVES K063757MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES K041276POWDER-FREE NITRILE EXAMINATION GLOVES K030207NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 K013261MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE

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.