Aero Blue Performance Surgical Gowns
FDA 510(k) clearance K192362 · decided 2019-12-13
Clearance details
- K-number
- K192362
- Device name
- Aero Blue Performance Surgical Gowns
- Applicant
- O&M Halyard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-30
- Decision date
- 2019-12-13
- Days to decision
- 105 days
- Clearance type
- Abbreviated
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mechanicsville, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 recall (Z-0343-2023) | Owens & Minor Distribution, Inc. | 2022-12-06 |