FDA 510(k)

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

Número K: K182948 · 2019-03-22

RequerenteAnsell Healthcare Products, LLC

Data da decisão2019-03-22

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K182948. 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 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs?

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K182948.

When did Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182948.

Who is the listed applicant for Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs 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 Ansell Healthcare Products, LLC como candidato(a)

K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Ver todos os 14 dispositivos →

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.