NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE— 510(k) K033086

Substantially Equivalent

Pt. Medisafe Technologies

FDA 510(k) clearance K033086 for NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE, Substantially Equivalent on 2004-02-26. Applicant: Pt. Medisafe Technologies.

Clearance details

Applicant: Pt. Medisafe Technologies
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2003-09-29
Decision date: 2004-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tanjung Morawa, Medan, ID

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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.