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FDA 510(k)

Disposable Sterilized Latex Surgical Gloves

K-Number: K211953 · 2022-05-25

ApplicantJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Decision Date2022-05-25
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Sterilized Latex Surgical Gloves is a medical device manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under approval number K211953. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Sterilized Latex Surgical Gloves?

Disposable Sterilized Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K211953.

When was Disposable Sterilized Latex Surgical Gloves approved by the FDA?

Disposable Sterilized Latex Surgical Gloves received FDA 510(k) clearance on 2022-05-25, under approval number K211953.

What company makes Disposable Sterilized Latex Surgical Gloves?

Disposable Sterilized Latex Surgical Gloves is manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd..

What is the FDA product code for Disposable Sterilized Latex Surgical Gloves?

The FDA product code for Disposable Sterilized Latex Surgical Gloves is KGO.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Other Devices by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K212290Examination gloves -Type C (Nitrile gloves) K214017Examination gloves-Type A(Latex gloves)

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, Inc.

Official Source

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

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