K232252

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

510(k) number: K232252
Device name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
Applicant: Dehai (Shandong) Medical Gloves, Co., Ltd. CN
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2023-11-28
Date received: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain

Also available from FDA: K232252.pdf

Official FDA record: K232252

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