ELASTYREN - EXAMINATION AND DENTAL GLOVES— 510(k) K901394

Substantially Equivalent

Danpren Gloves A/S

FDA 510(k) clearance K901394 for ELASTYREN - EXAMINATION AND DENTAL GLOVES, Substantially Equivalent on 1990-08-10. Applicant: Danpren Gloves A/S.

Clearance details

Applicant: Danpren Gloves A/S
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1990-03-26
Decision date: 1990-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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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.