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FDA 510(k)

DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES

K-Number: K040828 · 2004-04-19

ApplicantZibo Borui Plastic & Rubber Products Co., Ltd.
Decision Date2004-04-19
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Borui Plastic & Rubber Products Co., Ltd.. It received FDA 510(k) clearance on 2004-04-19 under 510(k) number K040828. 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 POWDERED VINYL PATIENT EXAMINATION GLOVES?

DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2004-04-19. The listed applicant is Zibo Borui Plastic & Rubber Products Co., Ltd.. The 510(k) number is K040828.

When did DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 2004-04-19, under 510(k) number K040828.

Who is the listed applicant for DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists Zibo Borui Plastic & Rubber Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES?

The FDA product code for DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES 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 Zibo Borui Plastic & Rubber Products Co., 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.

K042028VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE

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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