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FDA 510(k)

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

K-Number: K032272 · 2003-08-26

ApplicantEst International Corporation
Decision Date2003-08-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Est International Corporation. It received FDA 510(k) clearance on 2003-08-26 under 510(k) number K032272. 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 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR?

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR is a medical device that received FDA 510(k) clearance on 2003-08-26. The listed applicant is Est International Corporation. The 510(k) number is K032272.

When did DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR receive FDA 510(k) clearance?

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR received FDA 510(k) clearance on 2003-08-26, under 510(k) number K032272.

Who is the listed applicant for DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR?

The FDA 510(k) record lists Est International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR?

The FDA product code for DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR 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 Est International Corporation 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.

K040108OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLINK041325DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREEK032236DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

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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