Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYA — Predicate Candidate Screening
297 FDA 510(k) clearances under this product code; the 50 most recent screened below.
129 daysmedian FDA review time
372 days90th percentile
297clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 | 130 | 0 |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | 2026-07-10 | 29 | 0 |
| K252575 | Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large ( | New York Embroidery Studio (NYES) | 2026-06-04 | 294 | 0 |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 | 68 | 0 |
| K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | 2026-04-28 | 211 | 0 |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Su | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 | 213 | 0 |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | 2026-02-26 | 254 | 0 |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 | 195 | 0 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 | 280 | 0 |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | 2025-05-30 | 197 | 0 |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 | 222 | 0 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025-02-26 | 159 | 0 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 | 163 | 0 |
| K241214 | ProPel SG3™ Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 | 133 | 0 |
| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 | 270 | 0 |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 | 185 | 0 |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 | 126 | 0 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 | 212 | 0 |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposabl | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 | 170 | 0 |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023-08-22 | 89 | 0 |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | 2023-08-16 | 168 | 0 |
| K230838 | Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown wi | Cardinal Health200, LLC | 2023-07-27 | 122 | 0 |
| K222999 | Surgical Gown | Hubei Woozon Healthcare Co., Ltd. | 2023-06-16 | 261 | 0 |
| K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | 2023-03-12 | 209 | 0 |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-03-07 | 118 | 0 |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, | Stringking | 2023-02-23 | 268 | 0 |
| K213844 | Surgical Gown | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023-02-16 | 434 | 0 |
| K220435 | SEJONG Surgical Gown Soft | Sejong Healthcare Co., Ltd. | 2023-02-10 | 361 | 0 |
| K222403 | Surgical Gown | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-01-26 | 170 | 0 |
| K213893 | Comfort Gown, Safewear Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2022-12-21 | 372 | 0 |
| K212812 | Surgical Gown | Xianning Marveldas Protective Articles Co., Ltd. | 2022-11-16 | 439 | 0 |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical G | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 | 89 | 0 |
| K221139 | Bodygard SFS Surgical Gown Level 4 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022-11-10 | 205 | 0 |
| K211060 | Disposable Surgical Gown Rk-3011C | Xiantao Rhycom Non-Woven Products Co., Ltd. | 2022-10-28 | 567 | 0 |
| K221977 | Disposable Surgical Gown (G4003) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-10-20 | 107 | 0 |
| K220092 | YADU Surgical Gowns | Henan Yadu Industrial Co., Ltd. | 2022-10-07 | 268 | 0 |
| K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-09-29 | 115 | 0 |
| K221717 | Disposable Surgical Gown UM-148 | Unimax Medical Products Co., Ltd. | 2022-09-20 | 99 | 0 |
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgica | Winner Medical Co., Ltd. | 2022-09-19 | 88 | 0 |
| K211399 | Sterile Level 3 Surgical Gown | Barco Tekstil Sanayi VE Ticaret A.S. | 2022-07-22 | 443 | 0 |
| K220665 | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Steri | Excellent Medical Technology Group Co., Ltd. | 2022-06-03 | 88 | 0 |
| K220333 | Medline Orbis LVL 3 Surgical Gown | Medline Industries, LP | 2022-05-18 | 103 | 0 |
| K213177 | Plus Medical Cover Gown | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-11 | 225 | 0 |
| K214108 | Medline Orbis Chemo Surgical Gown | Medline Industries, LP | 2022-05-06 | 128 | 0 |
| K211036 | Plus Medical Chemotherapy Gown | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-04 | 392 | 0 |
| K214088 | Disposable Surgical Gown | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-04-12 | 105 | 0 |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile | Dukal Corporation | 2022-03-18 | 500 | 0 |
| K201351 | Maxima Surgical Gown | Elevate Textiles | 2022-03-11 | 659 | 0 |
| K213703 | Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 2022-03-04 | 100 | 0 |
| K202845 | Bodygard SFS Surgical Gown Level 3 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | 2022-02-24 | 517 | 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