FDA 510(k)

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE

N.º K: K171093 · 2017-07-19

SolicitanteSanrea Healthcare Products Pvt, Ltd.

Fecha de decisión2017-07-19

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is the device name listed in this FDA 510(k) record. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K171093. 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 STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171093.

When did STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE receive FDA 510(k) clearance?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE received FDA 510(k) clearance on 2017-07-19, under 510(k) number K171093.

Who is the listed applicant for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

The FDA 510(k) record lists Sanrea Healthcare Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

The FDA product code for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is LZA.

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Otros registros que enlistan a Sanrea Healthcare Products Pvt, Ltd. como solicitante

K171550Sterile Latex Surgical Gloves, Powder Free K171367SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX 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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