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FDA 510(k)

PRE-POWDERED VINYL EXAM GLOVE, NON STERILE

K-Number: K994036 · 1999-12-20

ApplicantShanghai Champion Plastic Products Co., Ltd.
Decision Date1999-12-20
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED VINYL EXAM GLOVE, NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Champion Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K994036. 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 PRE-POWDERED VINYL EXAM GLOVE, NON STERILE?

PRE-POWDERED VINYL EXAM GLOVE, NON STERILE is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Shanghai Champion Plastic Products Co., Ltd.. The 510(k) number is K994036.

When did PRE-POWDERED VINYL EXAM GLOVE, NON STERILE receive FDA 510(k) clearance?

PRE-POWDERED VINYL EXAM GLOVE, NON STERILE received FDA 510(k) clearance on 1999-12-20, under 510(k) number K994036.

Who is the listed applicant for PRE-POWDERED VINYL EXAM GLOVE, NON STERILE?

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

What is the FDA product code for PRE-POWDERED VINYL EXAM GLOVE, NON STERILE?

The FDA product code for PRE-POWDERED VINYL EXAM GLOVE, NON STERILE is LYZ.

Related Clinical Trials

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.

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Other records listing Shanghai Champion Plastic Products Co., Ltd. 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.

K002220NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUEK002218NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUEK002217NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITEK002216NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITEK994136POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES

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

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

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