FDA 510(k)

Powder free nitrile examination glove- blue, non-sterile

N.º K: K212804 · 2021-12-01

Fecha de decisión2021-12-01

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder free nitrile examination glove- blue, non-sterile is the device name listed in this FDA 510(k) record. The listed applicant is Hong Seng Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K212804. 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 examination glove- blue, non-sterile?

Powder free nitrile examination glove- blue, non-sterile is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Hong Seng Gloves Sdn Bhd. The 510(k) number is K212804.

When did Powder free nitrile examination glove- blue, non-sterile receive FDA 510(k) clearance?

Powder free nitrile examination glove- blue, non-sterile received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212804.

Who is the listed applicant for Powder free nitrile examination glove- blue, non-sterile?

The FDA 510(k) record lists Hong Seng 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 examination glove- blue, non-sterile?

The FDA product code for Powder free nitrile examination glove- blue, non-sterile is LZA.

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Otros registros que enlistan a Hong Seng Gloves Sdn Bhd como solicitante

K221164Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl K212801Powder free nitrile examination glove- black, non sterile K212802powder free nitrile examination glove - white, non-sterile

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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