Niomed Barrier Gowns
by Amerasia Corp. 510(k)
Active
510(k) K954747
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954747 | Date6 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The NIOMED BARRIER GOWNS are isolation and surgical gowns classified under product code FYC and device class 2. They are substantially equivalent to a legally marketed device and were cleared via the traditional 510(k) pathway.
The gowns were manufactured by Amerasia Corp. in Riverside, California, and received FDA 510(k) clearance on March 6, 1996, under K954747. They are intended for use in general and plastic surgery settings as isolation and surgical gowns.
Other devices from Amerasia Corp.
Questions
AI-generated answers, 1 Oct 2026
What are NIOMED BARRIER GOWNS used for?
NIOMED BARRIER GOWNS are intended for use in general and plastic surgery settings as isolation and surgical gowns, providing a barrier during procedures to protect both patient and healthcare worker.
How were NIOMED BARRIER GOWNS cleared for market?
NIOMED BARRIER GOWNS received FDA 510(k) clearance on March 6, 1996, under K954747, as they were determined to be substantially equivalent to a legally marketed device via the traditional 510(k) pathway.
Who manufactures NIOMED BARRIER GOWNS and where are they made?
NIOMED BARRIER GOWNS are manufactured by Amerasia Corp. at their facility located at 4121 Tigris Way, Riverside, California, 92503, United States.