FDA 510(k)

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

N.º K: K182043 · 2018-09-21

SolicitanteHebei Titans Hongsen Medical Technology Co., Ltd.

Fecha de decisión2018-09-21

Código de productoLYZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K182043. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K182043.

When did Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-09-21, under 510(k) number K182043.

Who is the listed applicant for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA 510(k) record lists Hebei Titans Hongsen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is LYZ.

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Otros registros que enlistan a Hebei Titans Hongsen Medical Technology Co., Ltd. como solicitante

K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)K223895Disposable Medical Nitrile Examination Gloves K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)K212097Disposable medical surgical mask K211229Vinyl compound examination gloves K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

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Dispositivos relacionados (Código: LYZ)

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Fuente oficial

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