FDA 510(k)

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

Número K: K220541 · 2022-06-02

Data da decisão2022-06-02

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220541. 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 PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K220541.

When did PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves receive FDA 510(k) clearance?

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220541.

Who is the listed applicant for PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

The FDA 510(k) record lists O&M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

The FDA product code for PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves is LZA.

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Outros registros que listam O&M Halyard, Inc. como candidato(a)

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