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FDA 510(k)

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

K-Number: K090513 · 2009-05-08

ApplicantShandong Huayue Glove Co., Ltd.
Decision Date2009-05-08
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 Shandong Huayue Glove Co., Ltd.. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K090513. 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 2009-05-08. The listed applicant is Shandong Huayue Glove Co., Ltd.. The 510(k) number is K090513.

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 2009-05-08, under 510(k) number K090513.

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

The FDA 510(k) record lists Shandong Huayue Glove 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Shandong Huayue Glove 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.

K090520STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (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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