FDA 510(k)

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)

Numéro K : K232064 · 2023-10-02

Date de décision2023-10-02

Code produitLZA

Comité consultatifPolitique : medical-regulatory-v1. Politique : medical-regulatory-v1. Politique : medical-regulatory-v1.

DécisionSubstantially Equivalent

Résumé du dispositif

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is the device name listed in this FDA 510(k) record. The listed applicant is Isikel Manufacturing, LLC. It received FDA 510(k) clearance on 2023-10-02 under 510(k) number K232064. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)?

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a medical device that received FDA 510(k) clearance on 2023-10-02. The listed applicant is Isikel Manufacturing, LLC. The 510(k) number is K232064.

When did Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) receive FDA 510(k) clearance?

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) received FDA 510(k) clearance on 2023-10-02, under 510(k) number K232064.

Who is the listed applicant for Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)?

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

What is the FDA product code for Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)?

The FDA product code for Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Gant de gynécologie en poudre gratuite en nitrile biodégradable, vert ; Gant de gynécologie en nitrile biodégradable en poudre gratuite testé pour utilisation avec 32 médicaments de chimiothérapie, Fentanyl et résistance à la perméation de l'acide gastriqueTop 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 Gants d'examen en nitrile bleu testés pour l'utilisation avec les médicaments de chimiothérapie et le citrate de fentanylCardinalhealth 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.

Source officielle

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