FDA 510(k)

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

Numéro K : K222181 · 2023-01-11

Date de décision2023-01-11

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K222181. 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 Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Iconic Medicare Sdn Bhd. The 510(k) number is K222181.

When did Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate receive FDA 510(k) clearance?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate received FDA 510(k) clearance on 2023-01-11, under 510(k) number K222181.

Who is the listed applicant for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

The FDA 510(k) record lists Iconic Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

The FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is LZA.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Système d'évaluation du cathéter Uro-Cam assisté par intelligence artificielle pour le diagnostic du cancer de la vessieNOT_YET_RECRUITING

Autres dossiers indiquant Iconic Medicare Sdn Bhd en tant que demandeur

K221648Iconic Latex Glove K212182Iconic Nitrile Glove

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.