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)

Powder Free Vinyl Patient Examination Gloves

K-Number: K210799 · 2021-05-14

ApplicantYunnan Huazhiyuan Medical Technology Co., Ltd.
Decision Date2021-05-14
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K210799. 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?

Powder Free Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. The 510(k) number is K210799.

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

Powder Free Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2021-05-14, under 510(k) number K210799.

Who is the listed applicant for Powder Free Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Yunnan Huazhiyuan Medical Technology 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?

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

Other records listing Yunnan Huazhiyuan Medical 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.

K213051Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)K212002Synthetic Vinyl Examination GlovesK210686Nitrile Patient Examination Glove

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.

↑