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FDA 510(k)

PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL

K-Number: K091471 · 2009-10-15

ApplicantCartagloves S.A.
Decision Date2009-10-15
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL is the device name listed in this FDA 510(k) record. The listed applicant is Cartagloves S.A.. It received FDA 510(k) clearance on 2009-10-15 under 510(k) number K091471. 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 PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL?

PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL is a medical device that received FDA 510(k) clearance on 2009-10-15. The listed applicant is Cartagloves S.A.. The 510(k) number is K091471.

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

PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL received FDA 510(k) clearance on 2009-10-15, under 510(k) number K091471.

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

The FDA 510(k) record lists Cartagloves S.A. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL 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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