POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE— 510(k) K041913

Substantially Equivalent

Pt. Medisafe Technologies

FDA 510(k) clearance K041913 for POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE, Substantially Equivalent on 2004-12-01. Applicant: Pt. Medisafe Technologies.

Clearance details

Applicant: Pt. Medisafe Technologies
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2004-07-15
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tanjung Morawa, Medan, ID

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.