KGQ · Cream, Gloving, Surgeon'S
General, Plastic Surgery · 21 CFR 878.4470 · Class 1
Overview
| Product Code | KGQ |
|---|---|
| Device Name | Cream, Gloving, Surgeon'S |
| Regulation | 21 CFR 878.4470 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910687 | GUARDIAN GEL, SURGEON'S GLOVING CREAM | Guardian Angel Products, Inc. | Oct 11, 1991 | SESE |
Top Applicants
- Guardian Angel Products, Inc. — 1 clearance
