FDA 510(k)

Blue Latex Examination Powder Free Gloves

N.º K: K192329 · 2019-11-25

SolicitanteJr Engineering & Medical Technologies (M) Sdn. Bhd.

Fecha de decisión2019-11-25

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Blue Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K192329. 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 Blue Latex Examination Powder Free Gloves?

Blue Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192329.

When did Blue Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Blue Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2019-11-25, under 510(k) number K192329.

Who is the listed applicant for Blue Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Latex Examination Powder Free Gloves?

The FDA product code for Blue Latex Examination Powder Free Gloves is LYY.

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Otros registros que enlistan a Jr Engineering & Medical Technologies (M) Sdn. Bhd. como solicitante

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Dispositivos relacionados (Código: LYY)

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 Limited K230573Powder 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 Bhd K223298Sterile 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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