Device Type ID | 2823 |
Device Name | Cream, Gloving, Surgeon's |
Regulation Description | Surgeon's Gloving Cream. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.4470 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KGQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2823 |
Device | Cream, Gloving, Surgeon's |
Product Code | KGQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Surgeon's Gloving Cream. |
CFR Regulation Number | 878.4470 [🔎] |