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FDA 510(k)

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

K-Number: K021961 · 2002-07-02

ApplicantCopioumed Intl., Inc.
Decision Date2002-07-02
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Copioumed Intl., Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021961. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE?

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Copioumed Intl., Inc.. The 510(k) number is K021961.

When did POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE receive FDA 510(k) clearance?

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021961.

Who is the listed applicant for POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE?

The FDA 510(k) record lists Copioumed Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE?

The FDA product code for POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE is LYZ.

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Other records listing Copioumed Intl., Inc. as applicant

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.

K030927POWDERED VINYL EXAM GLOVES, WHITEK021743(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOWK972624POLY (VINYL) EXAM GLOVE, POWDER-FREEK965237NURSES BOUFFANT CAPK971316POLY (VINYL) EXAM GLOVE, POWDEREDK960999ISOLATION GOWN

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Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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