FDA 510(k)

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

N.º K: K180646 · 2018-06-27

Fecha de decisión2018-06-27

Código de productoLZC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180646. 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 Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-06-27. The listed applicant is Halyard Health. The 510(k) number is K180646.

When did Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-06-27, under 510(k) number K180646.

Who is the listed applicant for Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

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 Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is LZC.

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Otros registros que enlistan a Halyard Health como solicitante

K181360ON-Q* Pump with Bolus K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves 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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