Definition: A Disposable Medical Glove (examination Or Surgeons) That Is Worn On The Examiner's Hand To Prevent Contamination Between Patient And Examiner. In Addition, These Gloves Have Been Tested For Permeation And Breakthrough Resistance Against Various Conc
| Device Type ID | 2724 |
| Device Name | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Physical State | A Disposable Medical Glove (examination Or Surgeons) That Is Worn On The Examiner's Hand To Prevent Contamination Between Patient And Examiner. In Addition, These Gloves Have Been Tested For Permeation And Breakthrough Resistance Against Various Conc |
| Technical Method | A Disposable Medical Glove (examination Or Surgeons) That Is Worn On The Examiner's Hand To Prevent Contamination Between Patient And Examiner. In Addition, These Gloves Have Been Tested For Permeation And Breakthrough Resistance Against Various Conc |
| 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 | OPJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2724 |
| Device | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Product Code | OPJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Patient Examination Glove. |
| CFR Regulation Number | 880.6250 [🔎] |