DeviceClearance

UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES— 510(k) K000688

Substantially Equivalent

N.S. Uni-Gloves Sdn. Bhd.

FDA 510(k) clearance K000688 for UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES, Substantially Equivalent on 2000-04-12. Applicant: N.S. Uni-Gloves Sdn. Bhd..

Clearance details

Applicant
N.S. Uni-Gloves Sdn. Bhd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Torrance, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.