Home › Device types › FYC
Gown, Isolation, Surgical
FDA product code FYC · Class 2 · General, Plastic Surgery
146
Registered devices
28
Adverse events
2
Recalls
68
510(k) clearances
Devices with this code
Medline — MEDLINE INDUSTRIES, INC.Paneffort — Paneffort, LLCPlus Medical Isolation Gown Level 3 — Foshan Nanhai Plus Medical Co., LtdMedline — MEDLINE INDUSTRIES, INC.Essentials — HENRY SCHEIN, INC.Tronex International, Inc. — TRONEX INTERNATIONAL, INC.PRIMED — priMED Medical Products IncHalyard — O&M HALYARD, INC.PremierPro — PRESTIGE AMERITECH, LTD.CALICO — Calico Medical Group LLCCALICO — Calico Medical Group LLCFull Coverage Isolation Gown #RR-300FC — ICP MEDICAL, LLCPRIMED — priMED Medical Products IncCoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown — MEDTECS (TAIWAN) CORP.CARDINAL HEALTH — Cardinal Health 200, LLCRITMED VERSAGOWN — AMD Medicom IncCopioumed — COPIOUMED INTERNATIONAL INC.PRIMED — priMED Medical Products IncMediChoice — OWENS & MINOR DISTRIBUTION, INC.Plus Medical Isolation Gown Level 3 — Foshan Nanhai Plus Medical Co., LtdHENRY SCHEIN — HENRY SCHEIN, INC.CARDINAL HEALTH — Cardinal Health 200, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-01 | Cardinal Health 200, LLC | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Associat |
| 2024-11-01 | Cardinal Health 200, LLC | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Associat |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.