FDA 510(k)

Nitrile Glove Powder Free White

N.º K: K183068 · 2018-12-21

SolicitanteHaining Medical Products Co., Ltd.

Fecha de decisión2018-12-21

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Glove Powder Free White is the device name listed in this FDA 510(k) record. The listed applicant is Haining Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K183068. 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 Nitrile Glove Powder Free White?

Nitrile Glove Powder Free White is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Haining Medical Products Co., Ltd.. The 510(k) number is K183068.

When did Nitrile Glove Powder Free White receive FDA 510(k) clearance?

Nitrile Glove Powder Free White received FDA 510(k) clearance on 2018-12-21, under 510(k) number K183068.

Who is the listed applicant for Nitrile Glove Powder Free White?

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

What is the FDA product code for Nitrile Glove Powder Free White?

The FDA product code for Nitrile Glove Powder Free White is LZA.

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Otros registros que enlistan a Haining Medical Products Co., Ltd. como solicitante

K182528Nitrile Glove Powder Free Black K152715HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

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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