FDA 510(k)

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

Número K: K222898 · 2022-11-07

Data da decisão2022-11-07

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222898. 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 SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Safesource Direct, LLC. The 510(k) number is K222898.

When did SafeSource Direct Blue Powder-Free Nitrile Exam Gloves receive FDA 510(k) clearance?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222898.

Who is the listed applicant for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

The FDA 510(k) record lists Safesource Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

The FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is LZA.

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Outros registros que listam Safesource Direct, LLC como candidato(a)

K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)K221134Procedure Mask with Ear Loops and Surgical Mask with Ties

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.

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