Panels › General, Plastic Surgery › Product code FYA · Class 2
Gown, Surgical
Regulation 878.4040
10510(k)s in 12 months (298 all time)
5recalls in 12 months (129 all time)
106recalls that name a 510(k)
Top companies in FYA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 6, 1991 | K910515 | FREEDOM MARK III SURGICAL HELMET SYSTEM Stackhouse Assoc. | FYA |
| Apr 22, 1991 | K911568 | GOWN, OPERATING SURGICAL Huntsville Rehabilitation Foundation | FYA |
| Nov 29, 1990 | K901536 | STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV Depuy, Inc. | FYA |
| Sep 6, 1990 | K902348 | SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* Futuristic Medical Concepts, Inc. | FYA |
| Feb 16, 1990 | K896935 | CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE Baxter Healthcare Corp | FYA |
| Aug 11, 1989 | K894599 | SHIRT, OPERATING, SURGICAL Miroz Industries Co. | FYA |
| Jul 14, 1989 | K894284 | GOWN, OPERATING, SURGICAL Miroz Industries Co. | FYA |
| Apr 20, 1989 | K892118 | NON-STERILE MASKS AND CAPS Paramount Products, Inc. | FYA |
| Apr 14, 1989 | K891211 | SURGICAL GOWN #2001 Pro-Safe Professional Linens, Inc. | FYA |
| Apr 12, 1989 | K891058 | DENTAL GOWN Dispomed, Inc. | FYA |
| Feb 23, 1989 | K890474 | SURGICAL GOWNS Victoria Slipper Retail & Mfg., Co. | FYA |
| Aug 26, 1988 | K883464 | SURGICAL SHIRT Arkansas Lighthouse For the Blind | FYA |
| Aug 3, 1988 | K882470 | STERILE DISPOSABLE SURGICAL GOWNS Bolden Products, Div. of the Transport Group | FYA |
| Jun 23, 1988 | K880386 | KIMBERLY-CLARK PROTECTIVE SLEEVE Kimberly-Clark Corp. | FYA |
| Jun 23, 1988 | K880383 | KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON Kimberly-Clark Corp. | FYA |
| Jun 23, 1988 | K880382 | KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN Kimberly-Clark Corp. | FYA |
| Jul 31, 1987 | K872758 | THEATRE GOWNS Smith & Nephew, Inc. | FYA |
| Jun 9, 1987 | K871906 | UNIMED SURGEON'S GOWNS Unimed Hospital Supply Corp. | FYA |
| Nov 26, 1986 | K864311 | STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) Clinitech, Inc. | FYA |
| May 12, 1986 | K861600 | SPUNGUARD PLUS SURGICAL GOWN Kimberly-Clark Corp. | FYA |
| Jul 23, 1985 | K852870 | BARRIER SURGICAL GOWN Surgikos, Inc. | FYA |
| Jun 28, 1985 | K851938 | OMNIMED SURGICAL GOWN Omni Intl., Inc. | FYA |
| Apr 30, 1985 | K851559 | TURQUOISE Roseburg SA | FYA |
| Feb 21, 1985 | K850177 | MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN) Matrix Medica, Inc. | FYA |
| Jan 10, 1985 | K844703 | GOWNS, SURGICAL Medicon, Inc. | FYA |
| Aug 17, 1984 | K842958 | BOUNDARY SINGLE-USE OR GOWN Procter & Gamble Mfg. Co. | FYA |
| May 1, 1984 | K834332 | BOUNDARY SINGLE-USE GOWNS Procter & Gamble Mfg. Co. | FYA |
| Jan 12, 1983 | K822925 | BOUNDARY SINGLE-USE GOWNS The Buckeye Cellulose Corp. | FYA |
| Jul 2, 1982 | K821564 | BOUNDARY PROCESS CHANGE The Buckeye Cellulose Corp. | FYA |
| Mar 8, 1982 | K820363 | DISPOSABLE SURGICAL GARMENTS Alphamedix, Inc. | FYA |
| Feb 23, 1982 | K820116 | BOUNDARY The Buckeye Cellulose Corp. | FYA |
| Jan 5, 1982 | K813390 | BONDARY SINGLE-USE OR GOWN The Buckeye Cellulose Corp. | FYA |
| Jul 27, 1981 | K811958 | BOUNDARY REINFORCED OR GOWN The Buckeye Cellulose Corp. | FYA |
| Jan 15, 1981 | K803158 | IRRADIATED BOUNDARY DEVICES The Buckeye Cellulose Corp. | FYA |
| Jan 15, 1981 | K802885 | L.A.F. ISOLATION PACK Action Medical Systems, Inc. | FYA |
| May 30, 1980 | K801025 | ODOR MASKING AGENT FOR CONTENTS OF ALL The Buckeye Cellulose Corp. | FYA |
| May 20, 1980 | K800929 | WHITE KNIGHT SURGICAL PACK G.D. Searle and Co. | FYA |
| May 20, 1980 | K800927 | WHITE KNIGHT DISP. STERILE BACK GOWN G.D. Searle and Co. | FYA |
| Feb 5, 1980 | K800124 | ULTRASOFT GOWN Mars Mfg Co. | FYA |
| Jan 11, 1980 | K792622 | STERILIZATION PROCESS /USE GOWNS Procter & Gamble Mfg. Co. | FYA |
| Jun 20, 1979 | K791062 | BOUNDARY SPECIALTY GOWN Procter & Gamble Mfg. Co. | FYA |
| Dec 20, 1978 | K781682 | SURGICAL GOWNS & DRAPES Kimberly-Clark Corp. | FYA |
| Aug 14, 1978 | K781099 | SURGICAL GOWNS AND DRAPES Convertors | FYA |
| Dec 8, 1977 | K772182 | SURGICAL GOWN, REINFORCED Surgikos, Inc. | FYA |
| Nov 12, 1976 | K760554 | APPAREL, BARRIER SCRUB Surgikos, Inc. | FYA |
| Nov 11, 1976 | K760903 | BARRIER FABRIC 450 SURGICAL GOWNS Surgikos, Inc. | FYA |
| Nov 3, 1976 | K760864 | BARRIER FABRIC 450 SPECIALTY GOWN Surgikos, Inc. | FYA |
| Aug 11, 1976 | K760237 | GOWN, BOUNDARY SINGLE USE REINFORCED Procter & Gamble Mfg. Co. | FYA |
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