FDA 510(k)

Powder Free Polychloroprene Examination Glove Green

N.º K: K153510 · 2016-03-21

Fecha de decisión2016-03-21

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Polychloroprene Examination Glove Green is the device name listed in this FDA 510(k) record. The listed applicant is Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K153510. 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 Powder Free Polychloroprene Examination Glove Green?

Powder Free Polychloroprene Examination Glove Green is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K153510.

When did Powder Free Polychloroprene Examination Glove Green receive FDA 510(k) clearance?

Powder Free Polychloroprene Examination Glove Green received FDA 510(k) clearance on 2016-03-21, under 510(k) number K153510.

Who is the listed applicant for Powder Free Polychloroprene Examination Glove Green?

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

What is the FDA product code for Powder Free Polychloroprene Examination Glove Green?

The FDA product code for Powder Free Polychloroprene Examination Glove Green is LZA.

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Otros registros que enlistan a Terang Nusa Sdn Bhd como solicitante

K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink

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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