FDA 510(k)

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs

N.º K: K152222 · 2016-04-21

Fecha de decisión2016-04-21

Código de productoLZC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn Bhd (F25). It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152222. 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 NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Gmp Medicare Sdn Bhd (F25). The 510(k) number is K152222.

When did NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs receive FDA 510(k) clearance?

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152222.

Who is the listed applicant for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

The FDA 510(k) record lists Gmp Medicare Sdn Bhd (F25) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

The FDA product code for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is LZC.

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Otros registros que enlistan a Gmp Medicare Sdn Bhd (F25) como solicitante

K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink K172867Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange

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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