FDA 510(k)

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

N.º K: K223298 · 2023-02-22

SolicitanteShandong Intco Medical Products Co, Ltd.

Fecha de decisión2023-02-22

Código de productoLYY

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K223298. 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 Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)?

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K223298.

When did Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) receive FDA 510(k) clearance?

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) received FDA 510(k) clearance on 2023-02-22, under 510(k) number K223298.

Who is the listed applicant for Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)?

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

What is the FDA product code for Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)?

The FDA product code for Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is LYY.

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Otros registros que enlistan a Shandong Intco Medical Products Co, Ltd. como solicitante

K233042Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K231408Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile K213509Latex Examination Gloves, Powder Free

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 K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.

Fuente oficial

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