FDA 510(k)

Medical Examination Gloves

N.º K: K212078 · 2021-10-08

SolicitanteGuangdong Gymda Medical Technology Co.,Ltd

Fecha de decisión2021-10-08

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Gymda Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K212078. 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 Medical Examination Gloves?

Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Guangdong Gymda Medical Technology Co.,Ltd. The 510(k) number is K212078.

When did Medical Examination Gloves receive FDA 510(k) clearance?

Medical Examination Gloves received FDA 510(k) clearance on 2021-10-08, under 510(k) number K212078.

Who is the listed applicant for Medical Examination Gloves?

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

What is the FDA product code for Medical Examination Gloves?

The FDA product code for Medical Examination Gloves is LZA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Guangdong Gymda Medical Technology Co.,Ltd como solicitante

K212506Medical Examination Gloves (Tested for Use with Chemotherapy)

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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