POWDER FREE NITRILE EXAMINATION GLOVE— 510(k) K011012

Substantially Equivalent

Contract Latex Dippers Sdn Bhd

FDA 510(k) clearance K011012 for POWDER FREE NITRILE EXAMINATION GLOVE, Substantially Equivalent on 2001-05-01. Applicant: Contract Latex Dippers Sdn Bhd.

Clearance details

Applicant
Contract Latex Dippers Sdn Bhd
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Batang Kali, Selangor, MY
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.