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FDA 510(k)

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

N.º K: K160781 · 2017-05-02

SolicitanteSemperit Investments Asia Pte , Ltd.
Fecha de decisión2017-05-02
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Investments Asia Pte , Ltd.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K160781. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Semperit Investments Asia Pte , Ltd.. The 510(k) number is K160781.

When did Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves receive FDA 510(k) clearance?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves received FDA 510(k) clearance on 2017-05-02, under 510(k) number K160781.

Who is the listed applicant for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

The FDA 510(k) record lists Semperit Investments Asia Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

The FDA product code for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is KGO.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Otros registros que enlistan a Semperit Investments Asia Pte , Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy DrugsK171378Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs

Dispositivos relacionados (Código: KGO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Fuente oficial

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