FDA 510(k)

Disposable Sterilized Latex Surgical Gloves

Número K: K211953 · 2022-05-25

RequerenteJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Data da decisão2022-05-25

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K211953.

When did Disposable Sterilized Latex Surgical Gloves receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Sterilized Latex Surgical Gloves?

The FDA 510(k) record lists Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. como candidato(a)

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

Dispositivos Relacionados (Código: KGO)

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH K240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.