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FDA 510(k)

SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE

K-Number: K111857 · 2011-09-21

ApplicantInmed Gloves Factory
Decision Date2011-09-21
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Gloves Factory. It received FDA 510(k) clearance on 2011-09-21 under 510(k) number K111857. 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 SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE?

SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE is a medical device that received FDA 510(k) clearance on 2011-09-21. The listed applicant is Inmed Gloves Factory. The 510(k) number is K111857.

When did SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE receive FDA 510(k) clearance?

SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE received FDA 510(k) clearance on 2011-09-21, under 510(k) number K111857.

Who is the listed applicant for SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE?

The FDA 510(k) record lists Inmed Gloves Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE?

The FDA product code for SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE is LYZ.

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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

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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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