FDA 510(k)

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

N.º K: K162381 · 2017-01-31

Fecha de decisión2017-01-31

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Healthy Glove Co., Ltd.. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K162381. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs?

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Healthy Glove Co., Ltd.. The 510(k) number is K162381.

When did HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-01-31, under 510(k) number K162381.

Who is the listed applicant for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Healthy Glove Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs is LZA.

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Otros registros que enlistan a Healthy Glove Co., Ltd. como solicitante

K152479HG Pro Nitrile Powder Free Examination Gloves

Dispositivos relacionados (Código: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fuente oficial

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