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FDA 510(k)

NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)

K-Number: K091422 · 2009-07-30

ApplicantNovapro Co., Ltd.
Decision Date2009-07-30
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) is the device name listed in this FDA 510(k) record. The listed applicant is Novapro Co., Ltd.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K091422. 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 NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)?

NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Novapro Co., Ltd.. The 510(k) number is K091422.

When did NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) receive FDA 510(k) clearance?

NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) received FDA 510(k) clearance on 2009-07-30, under 510(k) number K091422.

Who is the listed applicant for NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)?

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

What is the FDA product code for NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)?

The FDA product code for NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) 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 Novapro 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.

K091421NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)

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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