FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Blue

N.º K: K163553 · 2017-05-22

SolicitanteHebei Titans Medical Supply Technology Group., Ltd.

Fecha de decisión2017-05-22

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Nitrile Patient Examination Gloves, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Medical Supply Technology Group., Ltd.. It received FDA 510(k) clearance on 2017-05-22 under 510(k) number K163553. 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?

Powder Free Nitrile Patient Examination Gloves, Blue is a medical device that received FDA 510(k) clearance on 2017-05-22. The listed applicant is Hebei Titans Medical Supply Technology Group., Ltd.. The 510(k) number is K163553.

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

Powder Free Nitrile Patient Examination Gloves, Blue received FDA 510(k) clearance on 2017-05-22, under 510(k) number K163553.

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

The FDA 510(k) record lists Hebei Titans Medical Supply Technology Group., 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?

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

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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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