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FDA 510(k)

VINYL EXAM GLOVES, POWDER FREE

K-Number: K983494 · 1998-11-05

ApplicantGlormed Intl., Inc.
Decision Date1998-11-05
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL EXAM GLOVES, POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Glormed Intl., Inc.. It received FDA 510(k) clearance on 1998-11-05 under 510(k) number K983494. 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 EXAM GLOVES, POWDER FREE?

VINYL EXAM GLOVES, POWDER FREE is a medical device that received FDA 510(k) clearance on 1998-11-05. The listed applicant is Glormed Intl., Inc.. The 510(k) number is K983494.

When did VINYL EXAM GLOVES, POWDER FREE receive FDA 510(k) clearance?

VINYL EXAM GLOVES, POWDER FREE received FDA 510(k) clearance on 1998-11-05, under 510(k) number K983494.

Who is the listed applicant for VINYL EXAM GLOVES, POWDER FREE?

The FDA 510(k) record lists Glormed Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VINYL EXAM GLOVES, POWDER FREE?

The FDA product code for VINYL EXAM GLOVES, POWDER FREE 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 Glormed Intl., Inc. 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.

K041945POWDER-FREE BLUE VINYL EXAM GLOVESK031104POWDERED VINYL EXAM GLOVES, WHITEK021353POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITEK002340VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOWK981360VINYL PATIENT EXAMINATION GLOVE, POWDERED

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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