FDA 510(k)

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs

N.º K: K213325 · 2022-01-28

SolicitanteAnhui Xinyisheng Medical Technology Co.,Ltd

Fecha de decisión2022-01-28

Código de productoLZC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Xinyisheng Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213325. 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 Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs?

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Anhui Xinyisheng Medical Technology Co.,Ltd. The 510(k) number is K213325.

When did Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213325.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs?

The FDA 510(k) record lists Anhui Xinyisheng Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs?

The FDA product code for Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs is LZC.

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Otros registros que enlistan a Anhui Xinyisheng Medical Technology Co.,Ltd como solicitante

K213371Disposable Medical Nitrile Examination Gloves (Model:XYS-001)

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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