Definition: A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potential
| Device Type ID | 2721 |
| Device Name | Powder-free Polychloroprene Patient Examination Glove |
| Physical State | A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potential |
| Technical Method | A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potential |
| Target Area | Glove |
| Regulation Description | Non-powdered Patient Examination Glove. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OPC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2721 |
| Device | Powder-free Polychloroprene Patient Examination Glove |
| Product Code | OPC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Patient Examination Glove. |
| CFR Regulation Number | 880.6250 [🔎] |