Powder Free Nitrile Examination Gloves (Blue)— 510(k) K220284

Substantially Equivalent

Kgm Gloves Sdn. Bhd.

FDA 510(k) clearance K220284 for Powder Free Nitrile Examination Gloves (Blue), Substantially Equivalent on 2022-07-08. Applicant: Kgm Gloves Sdn. Bhd..

Clearance details

Applicant: Kgm Gloves Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2022-02-01
Decision date: 2022-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamunting, 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.