Definition: A Disposable Latex Examination Glove Is A Device Made Of Natural Rubber Latex Or Synthetic Rubber That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Provide A Barrie
| Device Type ID | 2667 |
| Device Name | Patient Examination Glove, Specialty |
| 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 | LZC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2667 |
| Device | Patient Examination Glove, Specialty |
| Product Code | LZC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Patient Examination Glove. |
| CFR Regulation Number | 880.6250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREPLUS (M) SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GMP MEDICARE SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GOLDEN WOODS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HALYARD HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WRP ASIA PACIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WRP ASIA PACIFIC SDN. BHD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Hole In Material | 7 |
Protective Measures Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 9 |