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FDA 510(k)

Ivory Glove Powder-Free Nitrile Examination Gloves

N.º K: K213681 · 2022-04-21

SolicitanteIvory Gloves Sdn. Bhd.
Fecha de decisión2022-04-21
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Ivory Glove Powder-Free Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Gloves Sdn. Bhd.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213681. 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 Ivory Glove Powder-Free Nitrile Examination Gloves?

Ivory Glove Powder-Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Ivory Gloves Sdn. Bhd.. The 510(k) number is K213681.

When did Ivory Glove Powder-Free Nitrile Examination Gloves receive FDA 510(k) clearance?

Ivory Glove Powder-Free Nitrile Examination Gloves received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213681.

Who is the listed applicant for Ivory Glove Powder-Free Nitrile Examination Gloves?

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

What is the FDA product code for Ivory Glove Powder-Free Nitrile Examination Gloves?

The FDA product code for Ivory Glove Powder-Free Nitrile Examination Gloves is LZA.

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Dispositivos relacionados (Código: LZA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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