Dress, Surgical
A surgical dress is a garment worn by surgical or clinical personnel in the operating room environment as part of the sterile attire required to maintain infection control standards during procedures. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FYE, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- FYE
- Device Class
- FDA class 1
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932731 | BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN | Apr 11, 1994 | Substantially Equivalent | Johnson & Johnson Medical, Inc. |
| K912790 | SURGICAL GOWN | Sep 19, 1991 | Substantially Equivalent | Unicor Federal Dept. of Justice |
| K910920 | PROTEKT GLOVES | May 15, 1991 | Substantially Equivalent | Intermedics Orthopedics |
| K910941 | LIFELINER SURGICAL GLOVE | May 09, 1991 | Substantially Equivalent | Depuy-Raynham |
| K895667 | STERILE SURGICAL GOWN | Oct 13, 1989 | Substantially Equivalent | Clinitech, Inc. |
| K895235 | VARIOUS DISPOSABLE SURGICAL GARMENTS | Sep 19, 1989 | Substantially Equivalent | Protect Corp. of Indiana, Inc. |
| K894760 | CLOTHINGUARD | Aug 18, 1989 | Substantially Equivalent | Barrier Concepts, Inc. |
FEI Numbers
This FDA classification entry is associated with 114 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 114 registration numbers. Click on an entry to view related FDA registrations.