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FDA 510(k)

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)

N.º K: K223235 · 2022-10-26

SolicitantePt. Sintong Unigolden Glove
Fecha de decisión2022-10-26
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Sintong Unigolden Glove. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K223235. 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 Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)?

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Pt. Sintong Unigolden Glove. The 510(k) number is K223235.

When did Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-10-26, under 510(k) number K223235.

Who is the listed applicant for Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)?

The FDA 510(k) record lists Pt. Sintong Unigolden Glove as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)?

The FDA product code for Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) 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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