FDA 510(k)

NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735

K-Number: K030207 · 2003-05-02

ApplicantShanghai Motex Healthcare Co., Ltd.

Decision Date2003-05-02

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 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 2003-05-02 under 510(k) number K030207. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735?

NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 is a medical device that received FDA 510(k) clearance on 2003-05-02. The listed applicant is Shanghai Motex Healthcare Co., Ltd.. The 510(k) number is K030207.

When did NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 receive FDA 510(k) clearance?

NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 received FDA 510(k) clearance on 2003-05-02, under 510(k) number K030207.

Who is the listed applicant for NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735?

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 NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735?

The FDA product code for NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 is LZA.

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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 K020837MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE K013261MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE

Related Devices (Code: LZA)

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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.