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FDA 510(k)

Single-use medical poly (vinyl chloride) examination glove

K-Number: K201504 · 2021-05-10

ApplicantAnhui Bytech Medical Supplies Co., Ltd.
Decision Date2021-05-10
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Single-use medical poly (vinyl chloride) examination glove is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Bytech Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-05-10 under 510(k) number K201504. 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 Single-use medical poly (vinyl chloride) examination glove?

Single-use medical poly (vinyl chloride) examination glove is a medical device that received FDA 510(k) clearance on 2021-05-10. The listed applicant is Anhui Bytech Medical Supplies Co., Ltd.. The 510(k) number is K201504.

When did Single-use medical poly (vinyl chloride) examination glove receive FDA 510(k) clearance?

Single-use medical poly (vinyl chloride) examination glove received FDA 510(k) clearance on 2021-05-10, under 510(k) number K201504.

Who is the listed applicant for Single-use medical poly (vinyl chloride) examination glove?

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

What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove is LYZ.

Other records listing Anhui Bytech Medical Supplies 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.

K222442DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)

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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