FDA 510(k)

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Numéro K : K211547 · 2021-07-15

Date de décision2021-07-15

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Edma Group, LLC. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K211547. 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 Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Edma Group, LLC. The 510(k) number is K211547.

When did Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211547.

Who is the listed applicant for Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

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

What is the FDA product code for Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) 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 NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Edma Group, LLC en tant que demandeur

K211540Edma Synthetic Nitrile Examination Gloves

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.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.

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.