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FDA 510(k)

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

Número K: K230217 · 2023-05-13

RequerenteGrand Work Plastic Products Co., Ltd.
Data da decisão2023-05-13
Código do produtoKGO
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2023-05-13 under 510(k) number K230217. 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 Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-05-13. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K230217.

When did Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-05-13, under 510(k) number K230217.

Who is the listed applicant for Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Grand Work Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is KGO.

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Outros registros que listam Grand Work Plastic Products Co., Ltd. como candidato(a)

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K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsK232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK222892Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy DrugsK213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black)K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

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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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