FDA 510(k)

ComfortPro Blue Nitrile Examination Gloves Powder Free

N.º K: K212850 · 2021-12-10

SolicitanteThai Rubber Industry Company Limited

Fecha de decisión2021-12-10

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

ComfortPro Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Thai Rubber Industry Company Limited. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K212850. 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 ComfortPro Blue Nitrile Examination Gloves Powder Free?

ComfortPro Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Thai Rubber Industry Company Limited. The 510(k) number is K212850.

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

ComfortPro Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2021-12-10, under 510(k) number K212850.

Who is the listed applicant for ComfortPro Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Thai Rubber Industry Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComfortPro Blue Nitrile Examination Gloves Powder Free?

The FDA product code for ComfortPro Blue Nitrile Examination Gloves Powder Free is LZA.

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Otros registros que enlistan a Thai Rubber Industry Company Limited como solicitante

K212438Comfortpro

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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.