Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)— 510(k) K250578

Substantially Equivalent

Careglove Global Sdn. Bhd.

FDA 510(k) clearance K250578 for Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), Substantially Equivalent on 2025-04-01. Applicant: Careglove Global Sdn. Bhd..

Clearance details

Applicant: Careglove Global Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2025-02-27
Decision date: 2025-04-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Seremban, MY

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.