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FDA 510(k)

Guantes de Examen de Paciente A1 Glove Sin Polvo de Latex con Etiqueta de Contenido de Proteínas (Contiene 50 Microgramos por dm2 de guante o Menos de Proteína Extractable con Agua)

N.º K: K153744 · 2016-08-04

SolicitanteA1 Glove Sdn Bhd
Fecha de decisión2016-08-04
Código de productoLYY
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) is the device name listed in this FDA 510(k) record. The listed applicant is A1 Glove Sdn Bhd. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153744. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)?

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is A1 Glove Sdn Bhd. The 510(k) number is K153744.

When did A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) receive FDA 510(k) clearance?

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153744.

Who is the listed applicant for A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)?

The FDA 510(k) record lists A1 Glove Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)?

The FDA product code for A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) is LYY.

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Dispositivos relacionados (Código: LYY)

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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Fuente oficial

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