ELASTYREN(R) PATIENT EXAMINATION GLOVES— 510(k) K946291

Substantially Equivalent

Eci Medical Technologies, Inc.

FDA 510(k) clearance K946291 for ELASTYREN(R) PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1995-02-14. Applicant: Eci Medical Technologies, Inc..

Clearance details

Applicant: Eci Medical Technologies, Inc.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1994-12-27
Decision date: 1995-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmondhill, Ontario, CA

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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.