Panels › General, Plastic Surgery › Product code FYC · Class 2
Gown, Isolation, Surgical
Regulation 878.4040
0510(k)s in 12 months (68 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FYC
| Company | 510(k)s | Recalls |
|---|---|---|
| American Threshold Industries, Inc. | 4 | 0 |
| American Hospital Supply Corp. | 3 | 0 |
| Amsco Sterile Recoveries, Inc. | 2 | 0 |
| Cardinal Health 200, LLC | 0 | 2 |
| Dynatech Medical Products | 2 | 0 |
| Hubei Xinxin Non-Woven Co., Ltd. | 2 | 0 |
| Kentron Health Care, Inc. | 2 | 0 |
| Medtek Development Corp. | 2 | 0 |
| A Plus International, Inc. | 1 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 1992 | K921058 | DISPOSABLE ISOLATION GOWN Nat'L Surtex Corp. | FYC |
| Apr 25, 1991 | K910410 | SURGICAL GOWNS, EXTRA-LARGE SIZE Dawn of Hope Development Center | FYC |
| Apr 20, 1989 | K891677 | COATED ISOLATION GOWN Durante Intl., Inc. | FYC |
| Jun 27, 1988 | K880484 | SURGICAL GARMENTS Greene International Corp., TW | FYC |
| Jun 23, 1988 | K882281 | GOWN, ISOLATION, SURGICAL (FYC) A Plus International, Inc. | FYC |
| Dec 30, 1987 | K874888 | ISOLATION GOWN Sage Products, Inc. | FYC |
| Dec 10, 1987 | K874766 | INTERPRO INT'L, INC. ISOLATION GOWN Interpro Intl., Inc. | FYC |
| Dec 2, 1987 | K874318 | MAXIMUM CONTROL GOWN Ulti-Med Intl., Inc. | FYC |
| Dec 9, 1986 | K864479 | CARETEX ISOLUTION GOWNS James River Corp. | FYC |
| May 17, 1985 | K851823 | DISPOSABLE ISOLATION GOWN American Threshold Industries, Inc. | FYC |
| Jan 18, 1985 | K844786 | NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR Durawear | FYC |
| Mar 19, 1984 | K840229 | CONTROL COVER GOWN Kimberly-Clark Corp. | FYC |
| May 23, 1980 | K801162 | BARRIER PLUS SURGEON GOWNS American Hospital Supply Corp. | FYC |
| May 20, 1980 | K801069 | STERILE ISOLATION GOWN Medspec Corp. | FYC |
| May 9, 1978 | K780605 | ISOLATION GOWN Abco Dealers, Inc. | FYC |
| May 23, 1977 | K770488 | ISOLATION GOWN General Medical Co. | FYC |
| Jan 28, 1977 | K761080 | ISOLATION GOWN PACK American Hospital Supply Corp. | FYC |
| Dec 30, 1976 | K760904 | CLEANING AND ISOLATION ROOM KIT American Hospital Supply Corp. | FYC |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.