FDA 510(k)

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove

N.º K: K190159 · 2019-05-06

Fecha de decisión2019-05-06

Código de productoLZC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile 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 2019-05-06 under 510(k) number K190159. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is Showa Best Glove, Inc.. The 510(k) number is K190159.

When did Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove receive FDA 510(k) clearance?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190159.

Who is the listed applicant for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile 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 Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

The FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is LZC.

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

K211003SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove K180468SBG Black Nitrile Powder Free Medical Examination Glove K180467SBG Blue Nitrile Powder Free Medical Examination Glove

Dispositivos relacionados (Código: LZC)

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealth K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

Fuente oficial

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