Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Vinyl Examination Glove

K-Number: K220469 · 2022-06-16

ApplicantChifeng Huawei Medical Science&Technology Co., Ltd.
Decision Date2022-06-16
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Vinyl Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Chifeng Huawei Medical Science&Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K220469. 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 Vinyl Examination Glove?

Disposable Vinyl Examination Glove is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Chifeng Huawei Medical Science&Technology Co., Ltd.. The 510(k) number is K220469.

When did Disposable Vinyl Examination Glove receive FDA 510(k) clearance?

Disposable Vinyl Examination Glove received FDA 510(k) clearance on 2022-06-16, under 510(k) number K220469.

Who is the listed applicant for Disposable Vinyl Examination Glove?

The FDA 510(k) record lists Chifeng Huawei Medical Science&Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Vinyl Examination Glove?

The FDA product code for Disposable Vinyl Examination Glove is LYZ.

Other records listing Chifeng Huawei Medical Science&Technology 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.

K212833Disposable Nitrile 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑