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FDA 510(k)

Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

N.º K: K213574 · 2022-07-12

SolicitanteGrand Work Plastic Products Co., Ltd.
Fecha de decisión2022-07-12
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-07-12 under 510(k) number K213574. 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 Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K213574.

When did Nitrile Vinyl Blend Powder Free Examination Gloves (Black) receive FDA 510(k) clearance?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) received FDA 510(k) clearance on 2022-07-12, under 510(k) number K213574.

Who is the listed applicant for Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

The FDA 510(k) record lists Grand Work Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

The FDA product code for Nitrile Vinyl Blend Powder Free Examination Gloves (Black) 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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