Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl— 510(k) K192954

Substantially Equivalent

Comfort Rubber Gloves Industries Sdn. Bhd.

FDA 510(k) clearance K192954 for Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Substantially Equivalent on 2020-06-19. Applicant: Comfort Rubber Gloves Industries Sdn. Bhd..

Clearance details

Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2019-10-21
Decision date: 2020-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Matang, 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.