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FDA 510(k)

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR

K-Number: K111459 · 2011-06-16

ApplicantJiangsu Alfa Glove Co., Ltd.
Decision Date2011-06-16
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Alfa Glove Co., Ltd.. It received FDA 510(k) clearance on 2011-06-16 under 510(k) number K111459. 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 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR?

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR is a medical device that received FDA 510(k) clearance on 2011-06-16. The listed applicant is Jiangsu Alfa Glove Co., Ltd.. The 510(k) number is K111459.

When did POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR receive FDA 510(k) clearance?

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR received FDA 510(k) clearance on 2011-06-16, under 510(k) number K111459.

Who is the listed applicant for POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR?

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

What is the FDA product code for POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR?

The FDA product code for POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR 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 Jiangsu Alfa Glove 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.

K081658POWDER-FREE VINYL EXAMINATION 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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