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FDA 510(k)

Single-Use Latex Sterile Surgical Gloves (SG100)

N.º K: K231446 · 2023-09-22

SolicitanteFitone Latex Products Co., Ltd. Guangdong
Fecha de decisión2023-09-22
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-Use Latex Sterile Surgical Gloves (SG100) is the device name listed in this FDA 510(k) record. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231446. 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 Single-Use Latex Sterile Surgical Gloves (SG100)?

Single-Use Latex Sterile Surgical Gloves (SG100) is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K231446.

When did Single-Use Latex Sterile Surgical Gloves (SG100) receive FDA 510(k) clearance?

Single-Use Latex Sterile Surgical Gloves (SG100) received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231446.

Who is the listed applicant for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA 510(k) record lists Fitone Latex Products Co., Ltd. Guangdong as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100) 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 Fitone Latex Products Co., Ltd. Guangdong 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.

K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsK222693Single-use medical latex examination gloves (LG100)K211927Nitrile examination gloves

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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