Home › Device types › OEA
Non-Surgical Gown
FDA product code OEA · Class 1 · General, Plastic Surgery
2,132
Registered devices
42
Adverse events
17
Recalls
0
510(k) clearances
Devices with this code
Britedent — Bright Supply, Inc.EMSRUN — Wuxi Emsrun Technology Co., Ltd.Cypress — MCKESSON MEDICAL-SURGICAL INC.MEDLINE — MEDLINE INDUSTRIES, INC.Halyard — O&M HALYARD, INC.Alleset — GRI Medical & Electronic Technology Co., Ltd.Maytex — MAYTEX CORPORATIONReversible Isolation Gown — STANDARD TEXTILE CO., INC.CARDINAL HEALTH — Cardinal Health 200, LLCHenry Schein — HENRY SCHEIN, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Henry Schein — HENRY SCHEIN, INC.Precaution/Isolation Gown — STANDARD TEXTILE CO., INC.Alleset — GRI Medical & Electronic Technology Co., Ltd.CARDINAL HEALTH — Cardinal Health 200, LLCDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCRegard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.VR — POLYCONVERSIONS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCSpecial Plus model gown (length 112 cm) size S — OMNIA SRLDisposable Isolation Gown — TNG INVESTMENT AND TRADING JOINT STOCK COMPANYPrecept® — PRECEPT MEDICAL PRODUCTS, INC.CARDINAL HEALTH — CARDINAL HEALTH 200, LLCPrecept® — PRECEPT MEDICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 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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