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FDA 510(k)

Polyisoprene Surgical Gloves

Número K: K230304 · 2023-08-09

RequerentePuyang Linshi Medical Supplies Co., Ltd.
Data da decisão2023-08-09
Código do produtoKGO
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Polyisoprene Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Puyang Linshi Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K230304. 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 Polyisoprene Surgical Gloves?

Polyisoprene Surgical Gloves is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Puyang Linshi Medical Supplies Co., Ltd.. The 510(k) number is K230304.

When did Polyisoprene Surgical Gloves receive FDA 510(k) clearance?

Polyisoprene Surgical Gloves received FDA 510(k) clearance on 2023-08-09, under 510(k) number K230304.

Who is the listed applicant for Polyisoprene Surgical Gloves?

The FDA 510(k) record lists Puyang Linshi Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyisoprene Surgical Gloves?

The FDA product code for Polyisoprene Surgical Gloves is KGO.

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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.

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Fonte oficial

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