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FDA 510(k)

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Número K: K213373 · 2022-03-10

RequerenteSmart Glove Corporation Sdn. Bhd.
Data da decisão2022-03-10
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corporation Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213373. 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 Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Smart Glove Corporation Sdn. Bhd.. The 510(k) number is K213373.

When did Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213373.

Who is the listed applicant for Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

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

What is the FDA product code for Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is LZA.

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Outros registros que listam Smart Glove Corporation Sdn. Bhd. como candidato(a)

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Dispositivos Relacionados (Código: LZA)

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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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fonte oficial

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