Device type
Non-Surgical Gown
Product code OEA · Class I · 21 CFR 878.4040 · General, Plastic Surgery
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
Recent 510(k)s
No 510(k) clearances in the archive for OEA.
Recent recalls
Sep 30, 2026
Z-3259-2026
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gown…
New York Embroidery Studio, Inc.
- OEA
- Class II
- Ongoing