FDA 510(k)

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

N.º K: K160709 · 2016-09-06

Fecha de decisión2016-09-06

Código de productoLZC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K160709. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Halyard Health. The 510(k) number is K160709.

When did HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves receive FDA 510(k) clearance?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves received FDA 510(k) clearance on 2016-09-06, under 510(k) number K160709.

Who is the listed applicant for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

The FDA product code for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is LZC.

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Otros registros que enlistan a Halyard Health como solicitante

K181360ON-Q* Pump with Bolus K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K153708Halyard Black-Orange Powder-Free Nitrile Exam Glove

Dispositivos relacionados (Código: LZC)

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealth K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

Fuente oficial

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