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FDA 510(k)

POWDER-FREE VINYL EXAMINATION GLOVES

K-Number: K033693 · 2004-01-16

ApplicantShen Wei (Usa), Inc.
Decision Date2004-01-16
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE VINYL EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei (Usa), Inc.. It received FDA 510(k) clearance on 2004-01-16 under 510(k) number K033693. 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 VINYL EXAMINATION GLOVES?

POWDER-FREE VINYL EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K033693.

When did POWDER-FREE VINYL EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDER-FREE VINYL EXAMINATION GLOVES received FDA 510(k) clearance on 2004-01-16, under 510(k) number K033693.

Who is the listed applicant for POWDER-FREE VINYL EXAMINATION GLOVES?

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

What is the FDA product code for POWDER-FREE VINYL EXAMINATION GLOVES?

The FDA product code for POWDER-FREE VINYL EXAMINATION GLOVES is LYZ.

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Other records listing Shen Wei (Usa), 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.

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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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