FDA 510(k)

Sterile Surgical Powder Free Latex Glove

Número K: K221424 · 2023-01-26

Data da decisão2023-01-26

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Surgical Powder Free Latex Glove is the device name listed in this FDA 510(k) record. The listed applicant is New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K221424. 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 Surgical Powder Free Latex Glove?

Sterile Surgical Powder Free Latex Glove is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is New Era Medicare Sdn. Bhd.. The 510(k) number is K221424.

When did Sterile Surgical Powder Free Latex Glove receive FDA 510(k) clearance?

Sterile Surgical Powder Free Latex Glove received FDA 510(k) clearance on 2023-01-26, under 510(k) number K221424.

Who is the listed applicant for Sterile Surgical Powder Free Latex Glove?

The FDA 510(k) record lists New Era Medicare Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Surgical Powder Free Latex Glove?

The FDA product code for Sterile Surgical Powder Free Latex Glove is KGO.

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Outros registros que listam New Era Medicare Sdn. Bhd. como candidato(a)

K230314Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)K221667Non Sterile Powder Free Latex Examination Glove

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

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