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FDA 510(k)

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)

Número K: K222349 · 2022-10-21

RequerenteJr Engineering & Medical Technologies (M) Sdn. Bhd.
Data da decisão2022-10-21
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) 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 2022-10-21 under 510(k) number K222349. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)?

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222349.

When did JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) receive FDA 510(k) clearance?

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222349.

Who is the listed applicant for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)?

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 JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)?

The FDA product code for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is LZA.

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Outros registros que listam Jr Engineering & Medical Technologies (M) Sdn. Bhd. como candidato(a)

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K222350Sterile Nitrile Surgical Gloves Powder FreeK221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl CitrateK222348JR MEDICK221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackK221157JR MedicK212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: LZA)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fonte oficial

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