Definition: A Powder-free Surgeon's Glove Is A Disposable Device Made Of Non-natural Rubber That May Bear A Trace Amount Of Residual Powder And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infecti
| Device Type ID | 2838 |
| Device Name | Powder-free Non-natural Rubber Latex Surgeon's Gloves |
| Physical State | A Powder-free Surgeon's Glove Is A Disposable Device Made Of Non-natural Rubber That May Bear A Trace Amount Of Residual Powder And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infecti |
| Technical Method | A Powder-free Surgeon's Glove Is A Disposable Device Made Of Non-natural Rubber That May Bear A Trace Amount Of Residual Powder And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infecti |
| Target Area | Glove |
| Regulation Description | Non-powdered Surgeon's Glove. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4460 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OPA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2838 |
| Device | Powder-free Non-natural Rubber Latex Surgeon's Gloves |
| Product Code | OPA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Surgeon's Glove. |
| CFR Regulation Number | 878.4460 [🔎] |