Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
FDA 510(k) clearance K232849 · decided 2024-05-16
Clearance details
- K-number
- K232849
- Device name
- Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-14
- Decision date
- 2024-05-16
- Days to decision
- 245 days
- Clearance type
- Abbreviated
- Product code
- FYC
- 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
No recalls on record reference this clearance.