FDA 510(k)

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

N.º K: K220232 · 2022-02-20

Fecha de decisión2022-02-20

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is the device name listed in this FDA 510(k) record. The listed applicant is Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-02-20 under 510(k) number K220232. 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 Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is a medical device that received FDA 510(k) clearance on 2022-02-20. The listed applicant is Megine Industries Sdn Bhd. The 510(k) number is K220232.

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

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange received FDA 510(k) clearance on 2022-02-20, under 510(k) number K220232.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

The FDA 510(k) record lists Megine Industries Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

The FDA product code for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is LZA.

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Otros registros que enlistan a Megine Industries Sdn Bhd como solicitante

K211310AMADEX - Guantes de examen sin látex de nitrilo (Azul, Negro, Naranja)

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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