NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE— 510(k) K984311

Substantially Equivalent

Sumirubber Industries (Kedah) Sdn. Bhd.

FDA 510(k) clearance K984311 for NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE, Substantially Equivalent on 1999-02-09. Applicant: Sumirubber Industries (Kedah) Sdn. Bhd..

Clearance details

Applicant: Sumirubber Industries (Kedah) Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1998-12-02
Decision date: 1999-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungai Petani, Kedah, 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.