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FDA 510(k)

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

Número K: K250496 · 2025-07-07

RequerenteZibo Shengkun Chemical Industry Co., Ltd.
Data da decisão2025-07-07
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Shengkun Chemical Industry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-07 under 510(k) number K250496. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)?

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is a medical device that received FDA 510(k) clearance on 2025-07-07. The listed applicant is Zibo Shengkun Chemical Industry Co., Ltd.. The 510(k) number is K250496.

When did Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) receive FDA 510(k) clearance?

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) received FDA 510(k) clearance on 2025-07-07, under 510(k) number K250496.

Who is the listed applicant for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)?

The FDA 510(k) record lists Zibo Shengkun Chemical Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)?

The FDA product code for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is LZA.

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Dispositivos Relacionados (Código: LZA)

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Fonte oficial

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