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

FDA 510(k)

Synthetic Vinyl Examination Gloves

K-Number: K211045 · 2021-06-23

ApplicantJiangsu Huayuan Medical Technology Co., Ltd.
Decision Date2021-06-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synthetic Vinyl Examination Gloves is a medical device manufactured by Jiangsu Huayuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-23 under approval number K211045. 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 Synthetic Vinyl Examination Gloves?

Synthetic Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-06-23. It is manufactured by Jiangsu Huayuan Medical Technology Co., Ltd.. The 510(k) number is K211045.

When was Synthetic Vinyl Examination Gloves approved by the FDA?

Synthetic Vinyl Examination Gloves received FDA 510(k) clearance on 2021-06-23, under approval number K211045.

What company makes Synthetic Vinyl Examination Gloves?

Synthetic Vinyl Examination Gloves is manufactured by Jiangsu Huayuan Medical Technology Co., Ltd..

What is the FDA product code for Synthetic Vinyl Examination Gloves?

The FDA product code for Synthetic Vinyl Examination Gloves is LYZ.

Related Clinical Trials

NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Jiangsu Huayuan Medical Technology Co., Ltd.

K213044Nitrile Examination Gloves

Related Devices (Code: LYZ)

K162259DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Zibo Daiyang Plastic Company K161390Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. K160675Powder free vinyl patient examination glove, colored (yellow)Kaixing Plastic Products Co., Litd. K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingCardinal Health, Inc. K161072Powder Free Grey Vinyl Examination GlovesZibo Flourish Trading Co., Ltd. K160468Synthetic Vinyl Examination Gloves, Powder-Free, YellowInpro Technology Device Factory

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.

↑