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FDA 510(k)

VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)

K-Number: K083600 · 2009-02-19

ApplicantQuantum Co., Ltd.
Decision Date2009-02-19
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Co., Ltd.. It received FDA 510(k) clearance on 2009-02-19 under 510(k) number K083600. 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 VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)?

VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) is a medical device that received FDA 510(k) clearance on 2009-02-19. The listed applicant is Quantum Co., Ltd.. The 510(k) number is K083600.

When did VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) receive FDA 510(k) clearance?

VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) received FDA 510(k) clearance on 2009-02-19, under 510(k) number K083600.

Who is the listed applicant for VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)?

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

What is the FDA product code for VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)?

The FDA product code for VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) 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 Quantum 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.

K083931SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE

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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