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FDA 510(k)

Vinyl Exam Gloves

K-Number: K213019 · 2022-01-05

ApplicantHebei Astro Medical Supply Co., Ltd.
Decision Date2022-01-05
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Astro Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K213019. 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 Vinyl Exam Gloves?

Vinyl Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Hebei Astro Medical Supply Co., Ltd.. The 510(k) number is K213019.

When did Vinyl Exam Gloves receive FDA 510(k) clearance?

Vinyl Exam Gloves received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213019.

Who is the listed applicant for Vinyl Exam Gloves?

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

What is the FDA product code for Vinyl Exam Gloves?

The FDA product code for Vinyl Exam Gloves is LYZ.

Other records listing Hebei Astro Medical Supply 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.

K221143Nitrile Exam Gloves (Blue, Black)

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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