FDA 510(k)

Nitrile Examination Gloves (Model: ZMG1351)

N.º K: K213688 · 2022-02-18

SolicitanteWuhan Zonsen Medical Products Co., Ltd.

Fecha de decisión2022-02-18

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Examination Gloves (Model: ZMG1351) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213688. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nitrile Examination Gloves (Model: ZMG1351)?

Nitrile Examination Gloves (Model: ZMG1351) is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K213688.

When did Nitrile Examination Gloves (Model: ZMG1351) receive FDA 510(k) clearance?

Nitrile Examination Gloves (Model: ZMG1351) received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213688.

Who is the listed applicant for Nitrile Examination Gloves (Model: ZMG1351)?

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

What is the FDA product code for Nitrile Examination Gloves (Model: ZMG1351)?

The FDA product code for Nitrile Examination Gloves (Model: ZMG1351) is LZA.

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Otros registros que enlistan a Wuhan Zonsen Medical Products Co., Ltd. como solicitante

K223600Sterilization Wrap K213601Surgical Mask K212357Surgical isolation gown K212861Surgical Gown, Reinforced Surgical Gown K202191Surgical Mask

Dispositivos relacionados (Código: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fuente oficial

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