FDA 510(k)

Iconic Nitrile Glove

Número K: K212182 · 2021-12-11

Data da decisão2021-12-11

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Iconic Nitrile Glove is the device name listed in this FDA 510(k) record. The listed applicant is Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2021-12-11 under 510(k) number K212182. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Iconic Nitrile Glove?

Iconic Nitrile Glove is a medical device that received FDA 510(k) clearance on 2021-12-11. The listed applicant is Iconic Medicare Sdn Bhd. The 510(k) number is K212182.

When did Iconic Nitrile Glove receive FDA 510(k) clearance?

Iconic Nitrile Glove received FDA 510(k) clearance on 2021-12-11, under 510(k) number K212182.

Who is the listed applicant for Iconic Nitrile Glove?

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

What is the FDA product code for Iconic Nitrile Glove?

The FDA product code for Iconic Nitrile Glove is LZA.

Ensaios clínicos relacionados

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Outros registros que listam Iconic Medicare Sdn Bhd como candidato(a)

K222181Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate K221648Iconic Latex Glove

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.

Fonte oficial

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