NUGARD NITILE GREY COLOR— 510(k) K102230

Substantially Equivalent

Terang Nusa Sdn Bhd

FDA 510(k) clearance K102230 for NUGARD NITILE GREY COLOR, Substantially Equivalent on 2010-09-10. Applicant: Terang Nusa Sdn Bhd.

Clearance details

Applicant: Terang Nusa Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2010-08-09
Decision date: 2010-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Kota Bharu, Kelantan, 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.