Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)— 510(k) K190950

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K190950 for Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced), Substantially Equivalent on 2019-07-04. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2019-04-11
Decision date: 2019-07-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.