FDA 510(k)

Edma Synthetic Nitrile Examination Gloves

N.º K: K211540 · 2021-08-09

Fecha de decisión2021-08-09

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Edma Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Edma Group, LLC. It received FDA 510(k) clearance on 2021-08-09 under 510(k) number K211540. 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 Edma Synthetic Nitrile Examination Gloves?

Edma Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-09. The listed applicant is Edma Group, LLC. The 510(k) number is K211540.

When did Edma Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

Edma Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-09, under 510(k) number K211540.

Who is the listed applicant for Edma Synthetic Nitrile Examination Gloves?

The FDA 510(k) record lists Edma Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edma Synthetic Nitrile Examination Gloves?

The FDA product code for Edma Synthetic Nitrile Examination Gloves is LZA.

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Otros registros que enlistan a Edma Group, LLC como solicitante

K211547Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

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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