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FDA 510(k)

Gammex PI Breach Detect Powder Free Surgical Glove

Número K: K171375 · 2018-02-06

RequerenteAnsell Healthcare Products, LLC
Data da decisão2018-02-06
Código do produtoKGO
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Gammex PI Breach Detect Powder Free Surgical Glove 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 2018-02-06 under 510(k) number K171375. 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 Breach Detect Powder Free Surgical Glove?

Gammex PI Breach Detect Powder Free Surgical Glove is a medical device that received FDA 510(k) clearance on 2018-02-06. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171375.

When did Gammex PI Breach Detect Powder Free Surgical Glove receive FDA 510(k) clearance?

Gammex PI Breach Detect Powder Free Surgical Glove received FDA 510(k) clearance on 2018-02-06, under 510(k) number K171375.

Who is the listed applicant for Gammex PI Breach Detect Powder Free Surgical Glove?

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 Breach Detect Powder Free Surgical Glove?

The FDA product code for Gammex PI Breach Detect Powder Free Surgical Glove is KGO.

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Outros registros que listam Ansell Healthcare Products, LLC como candidato(a)

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K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialK213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsK212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy DrugsK210401Microflex 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 CitrateK200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forK190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Ver todos os 14 dispositivos →

Dispositivos Relacionados (Código: KGO)

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.

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 LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene 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

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