POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)— 510(k) K972177

Substantially Equivalent

Absolute Synthetic Technologies Malaysia Sdn. Bhd.

FDA 510(k) clearance K972177 for POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED), Substantially Equivalent on 1997-07-29. Applicant: Absolute Synthetic Technologies Malaysia Sdn. Bhd..

Clearance details

Applicant: Absolute Synthetic Technologies Malaysia Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1997-06-10
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamunting, Taiping, Perak, MY

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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.