C2 MEDICAL GLOVES— 510(k) K113639

Substantially Equivalent

Amercare, Inc.

FDA 510(k) clearance K113639 for C2 MEDICAL GLOVES, Substantially Equivalent on 2012-05-08. Applicant: Amercare, Inc..

Clearance details

Applicant: Amercare, Inc.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2011-12-09
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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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.