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FDA 510(k)

VINYL PATIENT EXAMINATION GLOVE, POWDERED

K-Number: K981360 · 1998-10-15

ApplicantGlormed Intl., Inc.
Decision Date1998-10-15
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL PATIENT EXAMINATION GLOVE, POWDERED 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 1998-10-15 under 510(k) number K981360. 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 PATIENT EXAMINATION GLOVE, POWDERED?

VINYL PATIENT EXAMINATION GLOVE, POWDERED is a medical device that received FDA 510(k) clearance on 1998-10-15. The listed applicant is Glormed Intl., Inc.. The 510(k) number is K981360.

When did VINYL PATIENT EXAMINATION GLOVE, POWDERED receive FDA 510(k) clearance?

VINYL PATIENT EXAMINATION GLOVE, POWDERED received FDA 510(k) clearance on 1998-10-15, under 510(k) number K981360.

Who is the listed applicant for VINYL PATIENT EXAMINATION GLOVE, POWDERED?

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 PATIENT EXAMINATION GLOVE, POWDERED?

The FDA product code for VINYL PATIENT EXAMINATION GLOVE, POWDERED 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 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, YELLOWK983494VINYL EXAM GLOVES, POWDER FREE

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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