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FDA 510(k)

VINYL EXAMINATION GLOVES STERILE POWEDERED

K-Number: K020044 · 2002-02-26

ApplicantPrimus Gloves Private , Ltd.
Decision Date2002-02-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL EXAMINATION GLOVES STERILE POWEDERED is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Private , Ltd.. It received FDA 510(k) clearance on 2002-02-26 under 510(k) number K020044. 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 GLOVES STERILE POWEDERED?

VINYL EXAMINATION GLOVES STERILE POWEDERED is a medical device that received FDA 510(k) clearance on 2002-02-26. The listed applicant is Primus Gloves Private , Ltd.. The 510(k) number is K020044.

When did VINYL EXAMINATION GLOVES STERILE POWEDERED receive FDA 510(k) clearance?

VINYL EXAMINATION GLOVES STERILE POWEDERED received FDA 510(k) clearance on 2002-02-26, under 510(k) number K020044.

Who is the listed applicant for VINYL EXAMINATION GLOVES STERILE POWEDERED?

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

What is the FDA product code for VINYL EXAMINATION GLOVES STERILE POWEDERED?

The FDA product code for VINYL EXAMINATION GLOVES STERILE POWEDERED 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 Primus Gloves Private , 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.

K030444PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVESK030445POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAMK021065PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM

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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