K260867

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

510(k) number: K260867
Device name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
Applicant: Hartalega NGC Sdn. Bhd. MY
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2026-06-17
Date received: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K260867.pdf

Official FDA record: K260867

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