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FDA 510(k)

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES

K-Number: K032616 · 2003-10-02

ApplicantElite International, Inc.
Decision Date2003-10-02
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Elite International, Inc.. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K032616. 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?

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Elite International, Inc.. The 510(k) number is K032616.

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

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES received FDA 510(k) clearance on 2003-10-02, under 510(k) number K032616.

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

The FDA 510(k) record lists Elite International, Inc. 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?

The FDA product code for DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES is LYZ.

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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 Elite International, 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.

K040071ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLINK031113DISPOSABLE POWDER FREE VINYL EXAM GLOVESK031134DISPOSABLE POWDERED VINYL EXAM GLOVES

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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