K250861

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

510(k) number: K250861
Device name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
Applicant: Hartalega NGC Sdn. Bhd. MY
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2025-10-23
Date received: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K250861.pdf

Official FDA record: K250861

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.