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FDA 510(k)

Powder Free Latex Examination Glove, Non-Sterile

N.º K: K211601 · 2022-08-22

SolicitanteWrp Asia Pacific Sdn. Bhd.
Fecha de decisión2022-08-22
Código de productoLYY
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Latex Examination Glove, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2022-08-22 under 510(k) number K211601. 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 Powder Free Latex Examination Glove, Non-Sterile?

Powder Free Latex Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K211601.

When did Powder Free Latex Examination Glove, Non-Sterile receive FDA 510(k) clearance?

Powder Free Latex Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-08-22, under 510(k) number K211601.

Who is the listed applicant for Powder Free Latex Examination Glove, Non-Sterile?

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

What is the FDA product code for Powder Free Latex Examination Glove, Non-Sterile?

The FDA product code for Powder Free Latex Examination Glove, Non-Sterile is LYY.

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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 FentanylK232538DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYLK230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylK222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantK210330Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantK203030POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

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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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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