FDA 510(k)

Nitrile Glove Powder Free Blue

N.º K: K210145 · 2021-04-21

SolicitanteChangzhou Universal Medical Equipment Co., Ltd.

Fecha de decisión2021-04-21

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Glove Powder Free Blue is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210145. 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 Blue?

Nitrile Glove Powder Free Blue is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K210145.

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

Nitrile Glove Powder Free Blue received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210145.

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

The FDA 510(k) record lists Changzhou Universal Medical Equipment 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 Blue?

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

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Otros registros que enlistan a Changzhou Universal Medical Equipment Co., Ltd. como solicitante

K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

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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