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FDA 510(k)

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

N.º K: K162491 · 2017-02-08

SolicitanteHartalega Sdn Bhd
Fecha de decisión2017-02-08
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K162491. 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 Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K162491.

When did Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) received FDA 510(k) clearance on 2017-02-08, under 510(k) number K162491.

Who is the listed applicant for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?

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

What is the FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?

The FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is LZA.

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Otros registros que enlistan a Hartalega Sdn Bhd como solicitante

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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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