FDA 510(k)

SBG Black Nitrile Powder Free Medical Examination Glove

N.º K: K180468 · 2018-10-10

Fecha de decisión2018-10-10

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

SBG Black Nitrile Powder Free Medical Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K180468. 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 SBG Black Nitrile Powder Free Medical Examination Glove?

SBG Black Nitrile Powder Free Medical Examination Glove is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Showa Best Glove, Inc.. The 510(k) number is K180468.

When did SBG Black Nitrile Powder Free Medical Examination Glove receive FDA 510(k) clearance?

SBG Black Nitrile Powder Free Medical Examination Glove received FDA 510(k) clearance on 2018-10-10, under 510(k) number K180468.

Who is the listed applicant for SBG Black Nitrile Powder Free Medical Examination Glove?

The FDA 510(k) record lists Showa Best Glove, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SBG Black Nitrile Powder Free Medical Examination Glove?

The FDA product code for SBG Black Nitrile Powder Free Medical Examination Glove is LZA.

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Otros registros que enlistan a Showa Best Glove, Inc. como solicitante

K211003SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove K190159Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove K180467SBG Blue Nitrile Powder Free Medical Examination Glove

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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