FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

N.º K: K210755 · 2021-05-07

Fecha de decisión2021-05-07

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K210755. 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, Non-Sterile (Blue)?

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Meditech Gloves Sdn Bhd. The 510(k) number is K210755.

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

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) received FDA 510(k) clearance on 2021-05-07, under 510(k) number K210755.

Who is the listed applicant for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

The FDA 510(k) record lists Meditech Gloves Sdn Bhd 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, Non-Sterile (Blue)?

The FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is LZA.

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Otros registros que enlistan a Meditech Gloves Sdn Bhd como solicitante

K213408BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

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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