K210330

Substantially Equivalent

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

Applicant: Wrp Asia Pacific Sdn. Bhd.
Product code: LZA
Advisory panel: General Hospital
Date received: 2021-02-04
Decision date: 2022-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, 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.