FDA 510(k)

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Número K: K252075 · 2025-10-17

Data da decisão2025-10-17

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Program Insite, LLC. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K252075. 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 Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Program Insite, LLC. The 510(k) number is K252075.

When did Program insite® Powder-Free, Disposable Nitrile Exam Gloves receive FDA 510(k) clearance?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves received FDA 510(k) clearance on 2025-10-17, under 510(k) number K252075.

Who is the listed applicant for Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

The FDA 510(k) record lists Program Insite, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

The FDA product code for Program insite® Powder-Free, Disposable Nitrile Exam Gloves is LZA.

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Dispositivos Relacionados (Código: LZA)

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