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)

Vinyl Powder Free Examination Glove

K-Number: K212011 · 2022-02-14

ApplicantTop Glove Vietnam Company Limited
Decision Date2022-02-14
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Vietnam Company Limited. It received FDA 510(k) clearance on 2022-02-14 under 510(k) number K212011. 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 Powder Free Examination Glove?

Vinyl Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-02-14. The listed applicant is Top Glove Vietnam Company Limited. The 510(k) number is K212011.

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

Vinyl Powder Free Examination Glove received FDA 510(k) clearance on 2022-02-14, under 510(k) number K212011.

Who is the listed applicant for Vinyl Powder Free Examination Glove?

The FDA 510(k) record lists Top Glove Vietnam Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Powder Free Examination Glove?

The FDA product code for Vinyl Powder Free Examination Glove is LYZ.

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.

↑