Home › Device types › OEA
Non-Surgical Gown
FDA product code OEA · Class 1 · General, Plastic Surgery
2,224
Registered devices
49
Adverse events
18
Recalls
0
510(k) clearances
Devices with this code
AMXOR Imperative 3-Layer SMS Jacket — Amxor Healthcare LLCRITMED ASSUREWEAR — AMD Medicom IncPrecept® — PRECEPT MEDICAL PRODUCTS, INC.PremierPro — PRESTIGE AMERITECH, LTD.Maytex — MAYTEX CORPORATIONPolyWear — POLYCONVERSIONS, INC.GCB Medical Supply — GCB MEDICAL LLCPremierPro — PRESTIGE AMERITECH, LTD.McKesson — MCKESSON MEDICAL-SURGICAL INC.Essential Cares — Essential Cares Supplies, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCPrecept® — PRECEPT MEDICAL PRODUCTS, INC.3D Dental-Essentials — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC212NY — Two One Two New York, Inc.CARDINAL HEALTH — CARDINAL HEALTH 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — CARDINAL HEALTH 200, LLCPrecept® — PRECEPT MEDICAL PRODUCTS, INC.Henry Schein — HENRY SCHEIN, INC.CARDINAL HEALTH — Cardinal Health 200, LLCTronex International, Inc. — TRONEX INTERNATIONAL, INC.Halyard — O&M HALYARD, INC.MEDICOM SAFEWEAR — AMD Medicom IncRITMED — AMD Medicom Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | New York Embroidery Studio, Inc. | Gowns do not consistently meet the minimum liquid-barrier performance required. |
| 2024-06-03 | Stryker Corporation | Expired Products distributed to customers |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
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