Maximum Control Gown
by Ulti-Med Intl., Inc. 510(k)
Active
510(k) K874318
Overview
This is a surgical isolation gown, classified as a Class II medical device under FDA regulation 878.4040, with product code FYC. It is substantially equivalent to a legally marketed device and was cleared via the traditional 510(k) pathway under K874318.
The gown is supplied by Ulti-Med Intl., Inc. and is intended for use in general and plastic surgery settings. It is a non-sterile, reusable device unless otherwise specified in labeling, and its use, storage, and handling should follow the manufacturer’s instructions. No MRI safety information or specific sizes are provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874318 | Date2 Dec 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FYC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent