Definition: A Gown Intended To Protect Health Care Patients And Personnel From The Transfer Of Microorganisms, Body Fluids And Particulate Material
| Device Type ID | 2832 |
| Device Name | Non-surgical Isolation Gown |
| Physical State | An Isolation Gown Is Made Of Fabric Material, Either Non-woven Or Woven |
| Technical Method | Serves As Physical Barrier To The Transfer Of Microorganisms, Body Fluids And Particulate Material. Level Of Barrier Protection Is Nonspecific. |
| Target Area | An Isolation Gown Covers The Torso And Clothing And Poses A Physical Barrier To The Transfer Of Microorganisms, Body Fluids And Particulate Material |
| Regulation Description | Surgical Apparel. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4040 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OEA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2832 |
| Device | Non-surgical Isolation Gown |
| Product Code | OEA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cardinal Health | II | Sep-30-2016 |