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
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190950 | Date4 Jul 2019 | StatusActive |
Recalls
-
- Ongoing Z-2129-2026
- Ongoing Z-1424-2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FYA
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
This device is a surgical gown, as defined by its device type and nomenclature authority. It is designed to provide barrier protection during surgical procedures, with specific models offering AAMI Level 2 or Level 3 protection based on fabric construction and reinforcement. The gowns are available in non-reinforced and fabric-reinforced variants across multiple product lines including Eclipse, Sirus, and Aurora.
The gowns are supplied as single-use, sterile devices intended for use in healthcare settings such as operating rooms. They are cleared under FDA 510(k) authorization (K190950) with product code FYA and are classified as substantially equivalent. Sizes include XL (47 in) as referenced in the web context, and they are distributed in cases of 30 units. Storage and handling should follow standard practices for sterile single-use medical devices.
Other devices from Medline Industries, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the intended use of these Medline surgical gowns?
These surgical gowns are designed to provide barrier protection during surgical procedures, with specific models offering AAMI Level 2 or Level 3 protection based on fabric construction and reinforcement, as defined by their device type and nomenclature authority.
How are these gowns supplied and are they reusable?
The gowns are supplied as single-use, sterile devices intended for use in healthcare settings such as operating rooms, and are distributed in cases of 30 units; they are not designed for reuse due to their sterile, single-use nature.
What sizes are available for these Medline surgical gowns?
Sizes include XL (47 in) as referenced in the web context, with the gowns available across multiple product lines including Eclipse, Sirus, and Aurora in both non-reinforced and fabric-reinforced variants.
What regulatory pathway was used for these gowns?
The gowns are cleared under FDA 510(k) authorization (K190950) with product code FYA and are classified as substantially equivalent, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.