FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Blue Color

N.º K: K211860 · 2021-08-13

SolicitanteAnhui Powerguard Technology Co., Ltd.

Fecha de decisión2021-08-13

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Nitrile Patient Examination Gloves, Blue Color is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Powerguard Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211860. 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 Powder Free Nitrile Patient Examination Gloves, Blue Color?

Powder Free Nitrile Patient Examination Gloves, Blue Color is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Anhui Powerguard Technology Co., Ltd.. The 510(k) number is K211860.

When did Powder Free Nitrile Patient Examination Gloves, Blue Color receive FDA 510(k) clearance?

Powder Free Nitrile Patient Examination Gloves, Blue Color received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211860.

Who is the listed applicant for Powder Free Nitrile Patient Examination Gloves, Blue Color?

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

What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color?

The FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color is LZA.

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

K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl K191292Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

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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