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FDA 510(k)

Medical PVC Examination Gloves

K-Number: K210821 · 2021-07-09

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.
Decision Date2021-07-09
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical PVC Examination Gloves is a medical device manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-07-09 under approval number K210821. 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 Medical PVC Examination Gloves?

Medical PVC Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K210821.

When was Medical PVC Examination Gloves approved by the FDA?

Medical PVC Examination Gloves received FDA 510(k) clearance on 2021-07-09, under approval number K210821.

What company makes Medical PVC Examination Gloves?

Medical PVC Examination Gloves is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd..

What is the FDA product code for Medical PVC Examination Gloves?

The FDA product code for Medical PVC Examination Gloves is LYZ.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Jiangxi Hongda Medical Equipment Group , Ltd.

K163160Sterile Single-use Infusion Set K163162Sterile Hypodermic Safety Syringes for Single Use K163161Sterile Single-use Syringe with Needle K211753Sterile Syringe With Safety Needle K210578Medical Nitrile Examination Gloves (Power free, Blue)

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.

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