American Threshold Industries, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | June 24, 1997 |
| K953879 | SURGEON'S CAP | January 5, 1996 |
| K953878 | BOUFFANT CAP | January 5, 1996 |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | September 25, 1995 |
| K952114 | KOOL GARD SINGLES GOWN | September 25, 1995 |
| K952116 | COVER GOWN | September 5, 1995 |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | November 12, 1993 |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | August 17, 1992 |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | June 22, 1992 |
| K912110 | DISPOSABLE O.R. TOWEL | July 25, 1991 |
| K894383 | DISPOSABLE SHOE COVER | September 12, 1989 |
| K851823 | DISPOSABLE ISOLATION GOWN | May 17, 1985 |
| K832487 | DRAW SHEET, ANTI-MICROBIAL | February 13, 1984 |
| K832486 | PILLOW COVER, ANTI-MICROBIAL | February 13, 1984 |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | February 4, 1984 |
| K830473 | NOVA GAUZE | April 15, 1983 |
| K831062 | ISOLATION MASK I.C.S. | April 13, 1983 |
| K822484 | INFECTION CONTROL TOWEL | September 30, 1982 |
| K810646 | OR/CS WRAP | March 20, 1981 |
| K801036 | SURGICAL MASK | June 4, 1980 |