FDA Product Code
FDA Product Code FYC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 68 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | Owens & Minor (O&M) Halyard, Inc. | 2024-05-16 | Abbreviated | PDF ↗ |
| K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | 2023-10-04 | Traditional | PDF ↗ |
| K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co., Ltd. | 2023-02-08 | Traditional | PDF ↗ |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-01-04 | Traditional | PDF ↗ |
| K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | 2022-11-30 | Traditional | PDF ↗ |
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown | Medtecs (Taiwan) Corp. | 2022-10-21 | Traditional | PDF ↗ |
| K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 | Traditional | PDF ↗ |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-08-12 | Traditional | PDF ↗ |
| K220528 | Surgical Isolation Cover Gown | Wuhan Dymex Healthcare Co., Ltd. | 2022-06-10 | Traditional | PDF ↗ |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-05-16 | Traditional | PDF ↗ |
| K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. | 2022-04-29 | Traditional | PDF ↗ |
| K210148 | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | 2022-04-13 | Traditional | PDF ↗ |
| K212698 | Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co, Ltd. | 2022-03-02 | Traditional | PDF ↗ |
| K212357 | Surgical isolation gown | Wuhan Zonsen Medical Products Co., Ltd. | 2022-01-20 | Traditional | PDF ↗ |
| K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | String King Lacrosse, LLC | 2021-11-24 | Traditional | PDF ↗ |
| K211538 | Protect X Level 3 Isolation Gown | Azac Group | 2021-11-17 | Traditional | PDF ↗ |
| K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | 2021-11-13 | Traditional | PDF ↗ |
| K212504 | Isolation Gown AAMI Level 3 | Kenpax International Limited | 2021-11-07 | Traditional | PDF ↗ |
| K210131 | ComfortGuard Surgical Isolation Gown | Gri-Alleset, Inc. | 2021-08-26 | Traditional | PDF ↗ |
| K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | 2021-05-20 | Traditional | PDF ↗ |
| K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back | Wildcat Ppe, LLC | 2021-01-29 | Traditional | PDF ↗ |
| K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | 2020-01-17 | Traditional | PDF ↗ |
| K171535 | SURGICAL ISOLATION GOWN | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2018-02-15 | Traditional | PDF ↗ |
| K160471 | Medline Non-Surgical Isolation Gown- | Medline Industries, Inc. | 2017-01-31 | Traditional | PDF ↗ |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | Primed Medical Products, Inc. | 2016-11-04 | Traditional | PDF ↗ |
| K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016-07-28 | Traditional | PDF ↗ |
| K003749 | 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN | Banta Healthcare | 2001-02-23 | Traditional | PDF ↗ |
| K982369 | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS | Allegiance Healthcare Corp. | 1998-08-24 | Traditional | PDF ↗ |
| K972410 | IMPERVIOUS ISOLATION GOWN | Kentron Health Care, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K971917 | KENTRON'S ISOLATION GOWN | Kentron Health Care, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K971702 | FAR-EAST BARRIER GOWNS | Far East Science & Technology Development Co., Ltd. | 1997-07-08 | Traditional | PDF ↗ |
| K970814 | NON-STERILE ISOLATION GOWN | American Seal Co. | 1997-05-27 | Traditional | PDF ↗ |
| K960999 | ISOLATION GOWN | Copioumed Intl., Inc. | 1996-12-30 | Traditional | PDF ↗ |
| K954549 | SURGICAL APPAREL | Global Healthcare, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K954747 | NIOMED BARRIER GOWNS | Amerasia Corp. | 1996-03-06 | Traditional | PDF ↗ |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | American Threshold Industries, Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K952114 | KOOL GARD SINGLES GOWN | American Threshold Industries, Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K952116 | COVER GOWN | American Threshold Industries, Inc. | 1995-09-05 | Traditional | PDF ↗ |
| K942351 | DI ISOLATION GOWN | Derekduck Industries Corp. | 1995-05-17 | Traditional | PDF ↗ |
| K941845 | BUSE STAFF PROTECTION GOWNS AND KITS | Busse Hospital Disposables, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K945223 | OREX ISOLATION GOWN | Thantex Specialties, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K931145 | NON-STERILE ISOLATION GOWN | Amsco Sterile Recoveries, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K923162 | TBC TRAUMA SUIT PROTECTIVE GOWN | Tbc, Inc. | 1994-04-04 | Traditional | PDF ↗ |
| K922442 | ISOLATION GOWNS | Pfb Inter-Apparel Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K930026 | POLY-MED DISPOSABLE PERSONAL PROTECTION KIT | Medtek Development Corp. | 1993-10-04 | Traditional | PDF ↗ |
| K925077 | POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS | Medtek Development Corp. | 1993-08-16 | Traditional | PDF ↗ |
| K923188 | DYNASTY IMPERVIOUS ISOLATION J-SUIT | Dynatech Medical Products | 1993-01-29 | Traditional | PDF ↗ |
| K920404 | SURGEON'S GOWN | Amsco Sterile Recoveries, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K921058 | DISPOSABLE ISOLATION GOWN | Nat'L Surtex Corp. | 1992-08-11 | Traditional | PDF ↗ |
| K922234 | DYNASTY ISOLATION GOWN | Dynatech Medical Products | 1992-08-11 | Traditional | PDF ↗ |
| K910410 | SURGICAL GOWNS, EXTRA-LARGE SIZE | Dawn of Hope Development Center | 1991-04-25 | Traditional | PDF ↗ |
| K891677 | COATED ISOLATION GOWN | Durante Intl., Inc. | 1989-04-20 | Traditional | PDF ↗ |
| K880484 | SURGICAL GARMENTS | Greene International Corp. | 1988-06-27 | Traditional | PDF ↗ |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | A Plus International, Inc. | 1988-06-23 | Traditional | PDF ↗ |
| K874888 | ISOLATION GOWN | Sage Products, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K874766 | INTERPRO INT'L, INC. ISOLATION GOWN | Interpro Intl., Inc. | 1987-12-10 | Traditional | PDF ↗ |
| K874318 | MAXIMUM CONTROL GOWN | Ulti-Med Intl., Inc. | 1987-12-02 | Traditional | PDF ↗ |
| K864479 | CARETEX ISOLUTION GOWNS | James River Corp. | 1986-12-09 | Traditional | PDF ↗ |
| K851823 | DISPOSABLE ISOLATION GOWN | American Threshold Industries, Inc. | 1985-05-17 | Traditional | PDF ↗ |
| K844786 | NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR | Durawear | 1985-01-18 | Traditional | PDF ↗ |
| K840229 | CONTROL COVER GOWN | Kimberly-Clark Corp. | 1984-03-19 | Traditional | PDF ↗ |
| K801162 | BARRIER PLUS SURGEON GOWNS | American Hospital Supply Corp. | 1980-05-23 | Traditional | PDF ↗ |
| K801069 | STERILE ISOLATION GOWN | Medspec Corp. | 1980-05-20 | Traditional | PDF ↗ |
| K780605 | ISOLATION GOWN | Abco Dealers, Inc. | 1978-05-09 | Traditional | PDF ↗ |
| K770488 | ISOLATION GOWN | General Medical Co. | 1977-05-23 | Traditional | PDF ↗ |
| K761080 | ISOLATION GOWN PACK | American Hospital Supply Corp. | 1977-01-28 | Traditional | PDF ↗ |
| K760904 | CLEANING AND ISOLATION ROOM KIT | American Hospital Supply Corp. | 1976-12-30 | Traditional | PDF ↗ |
Product code FYC · Class II · General, Plastic Surgery. Data: openFDA.