FDA 510(k)

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)

N.º K: K162146 · 2017-01-05

Fecha de decisión2017-01-05

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K162146. 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 Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)?

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K162146.

When did Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) receive FDA 510(k) clearance?

Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) received FDA 510(k) clearance on 2017-01-05, under 510(k) number K162146.

Who is the listed applicant for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)?

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

What is the FDA product code for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)?

The FDA product code for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) is LZA.

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Otros registros que enlistan a Brightway Holdings Sdn. Bhd. como solicitante

K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM K163267NITRILE EXAMINATION GLOVE K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

Ver todos los 7 dispositivos →

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