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FDA 510(k)

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential

N.º K: K191860 · 2020-03-31

SolicitanteSemperit Technische Produkte Gesellchaft M.B.H.
Fecha de decisión2020-03-31
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Technische Produkte Gesellchaft M.B.H.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K191860. 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 Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Semperit Technische Produkte Gesellchaft M.B.H.. The 510(k) number is K191860.

When did Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential receive FDA 510(k) clearance?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential received FDA 510(k) clearance on 2020-03-31, under 510(k) number K191860.

Who is the listed applicant for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

The FDA 510(k) record lists Semperit Technische Produkte Gesellchaft M.B.H. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

The FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is KGO.

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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.

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Fuente oficial

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