Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYC · Predicate Candidate Screening
68 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
391 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Ha | Owens & Minor (O&M) Halyard, Inc. | 2024-05-16 | 245 | 0 |
| K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | 2023-10-04 | 259 | 0 |
| K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2023-02-10 | 85 | 0 |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co., Ltd. | 2023-02-08 | 104 | 0 |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-01-04 | 56 | 0 |
| K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | 2022-11-30 | 460 | 0 |
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown | Medtecs (Taiwan) Corp. | 2022-10-21 | 617 | 0 |
| K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 | 285 | 0 |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-08-12 | 128 | 0 |
| K220528 | Surgical Isolation Cover Gown | Wuhan Dymex Healthcare Co., Ltd. | 2022-06-10 | 106 | 0 |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-05-16 | 158 | 0 |
| K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. | 2022-04-29 | 268 | 0 |
| K210148 | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalo | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | 2022-04-13 | 447 | 0 |
| K212698 | Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co, Ltd. | 2022-03-02 | 189 | 0 |
| K212357 | Surgical isolation gown | Wuhan Zonsen Medical Products Co., Ltd. | 2022-01-20 | 175 | 0 |
| K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable | String King Lacrosse, LLC | 2021-11-24 | 97 | 0 |
| K211538 | Protect X Level 3 Isolation Gown | Azac Group | 2021-11-17 | 183 | 0 |
| K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | 2021-11-13 | 242 | 0 |
| K212504 | Isolation Gown AAMI Level 3 | Kenpax International Limited | 2021-11-07 | 90 | 0 |
| K210131 | ComfortGuard Surgical Isolation Gown | Gri-Alleset, Inc. | 2021-08-26 | 219 | 0 |
| K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | 2021-05-20 | 182 | 0 |
| K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Sur | Wildcat Ppe, LLC | 2021-01-29 | 168 | 0 |
| K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | 2020-01-17 | 339 | 0 |
| K171535 | SURGICAL ISOLATION GOWN | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2018-02-15 | 266 | 0 |
| K160471 | Medline Non-Surgical Isolation Gown- | Medline Industries, Inc. | 2017-01-31 | 347 | 0 |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | Primed Medical Products, Inc. | 2016-11-04 | 269 | 0 |
| K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016-07-28 | 171 | 2 |
| K003749 | 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN | Banta Healthcare | 2001-02-23 | 81 | 0 |
| K982369 | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS | Allegiance Healthcare Corp. | 1998-08-24 | 48 | 0 |
| K971917 | KENTRON'S ISOLATION GOWN | Kentron Health Care, Inc. | 1997-09-19 | 119 | 0 |
| K972410 | IMPERVIOUS ISOLATION GOWN | Kentron Health Care, Inc. | 1997-09-19 | 85 | 0 |
| K971702 | FAR-EAST BARRIER GOWNS | Far East Science & Technology Development Co., Ltd. | 1997-07-08 | 61 | 0 |
| K970814 | NON-STERILE ISOLATION GOWN | American Seal Co. | 1997-05-27 | 82 | 0 |
| K960999 | ISOLATION GOWN | Copioumed Intl., Inc. | 1996-12-30 | 293 | 0 |
| K954549 | SURGICAL APPAREL | Global Healthcare, Inc. | 1996-04-18 | 199 | 0 |
| K954747 | NIOMED BARRIER GOWNS | Amerasia Corp. | 1996-03-06 | 142 | 0 |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | American Threshold Industries, Inc. | 1995-09-25 | 143 | 0 |
| K952114 | KOOL GARD SINGLES GOWN | American Threshold Industries, Inc. | 1995-09-25 | 143 | 0 |
| K952116 | COVER GOWN | American Threshold Industries, Inc. | 1995-09-05 | 123 | 0 |
| K942351 | DI ISOLATION GOWN | Derekduck Industries Corp. | 1995-05-17 | 365 | 0 |
| K941845 | BUSE STAFF PROTECTION GOWNS AND KITS | Busse Hospital Disposables, Inc. | 1995-05-10 | 391 | 0 |
| K945223 | OREX ISOLATION GOWN | Thantex Specialties, Inc. | 1995-04-25 | 181 | 0 |
| K931145 | NON-STERILE ISOLATION GOWN | Amsco Sterile Recoveries, Inc. | 1994-06-10 | 462 | 0 |
| K923162 | TBC TRAUMA SUIT PROTECTIVE GOWN | Tbc, Inc. | 1994-04-04 | 644 | 0 |
| K922442 | ISOLATION GOWNS | Pfb Inter-Apparel Corp. | 1993-10-12 | 508 | 0 |
| K930026 | POLY-MED DISPOSABLE PERSONAL PROTECTION KIT | Medtek Development Corp. | 1993-10-04 | 272 | 0 |
| K925077 | POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS | Medtek Development Corp. | 1993-08-16 | 313 | 0 |
| K923188 | DYNASTY IMPERVIOUS ISOLATION J-SUIT | Dynatech Medical Products | 1993-01-29 | 213 | 0 |
| K920404 | SURGEON'S GOWN | Amsco Sterile Recoveries, Inc. | 1992-08-18 | 200 | 0 |
| K921058 | DISPOSABLE ISOLATION GOWN | Nat'L Surtex Corp. | 1992-08-11 | 159 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda