K251319

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff

510(k) number: K251319
Device name: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff
Applicant: Hartalega NGC Sdn. Bhd. MY
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2025-07-30
Date received: 2025-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K251319.pdf

Official FDA record: K251319

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