FDA 510(k)

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

N.º K: K252075 · 2025-10-17

Fecha de decisión2025-10-17

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Program Insite, LLC. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K252075. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Program Insite, LLC. The 510(k) number is K252075.

When did Program insite® Powder-Free, Disposable Nitrile Exam Gloves receive FDA 510(k) clearance?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves received FDA 510(k) clearance on 2025-10-17, under 510(k) number K252075.

Who is the listed applicant for Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

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

What is the FDA product code for Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

The FDA product code for Program insite® Powder-Free, Disposable Nitrile Exam Gloves is LZA.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.