Halyard
MICROCOOL* Breathable High Performance Specialty Gown with Blue Huck Towel, with SECURE-FIT*, XL, X-Long
68manufacturers in China registered for this device type
248catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (16), Hubei (13), Anhui (10). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Henan Yadu Industrial Co., Ltd. | Changyuan | Henan | Contract manufacturer | 35 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Weihai Dishang Medical Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
Showing 12 of 68. All 68 manufacturers in China registered for Gown, Surgical
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K080795 |
| Record published | 2016-04-15 |
| Record revised | 2025-03-03 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 30, case of 28, case of 12, case of 24, case of 26, case of 2 |
| Distribution end date | 2024-03-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 79970 | 40 | In distribution | |
| 44685 | In distribution | ||
| 13815 | In distribution | ||
| 76511 | 32 | In distribution | |
| 78945 | In distribution | ||
| 41737 | 44 | In distribution | |
| 42620 | In distribution | ||
| 44699 | In distribution | ||
| 44682 | In distribution | ||
| 78940 | In distribution | ||
| 11783 | In distribution | ||
| 44675 | In distribution | ||
| 95111 | In distribution | ||
| 90050 | In distribution | ||
| 44665 | 36 | In distribution | |
| 46872 | 14 | In distribution | |
| 71301 | 48 | In distribution | |
| 78913 | 54 | In distribution | |
| 78923 | 48 | In distribution | |
| 45184 | 28 | In distribution | |
| 41732 | In distribution | ||
| 95231 | In distribution | ||
| 43623 | 30 | In distribution | |
| 90138 | In distribution | ||
| 44686 | In distribution | ||
| 99295 | In distribution | ||
| 43940 | In distribution | ||
| 78950 | In distribution | ||
| 47347 | 10 | In distribution | |
| 95331 | In distribution | ||
| 95131 | In distribution | ||
| 44670 | 36 | In distribution | |
| 46881 | In distribution | ||
| 44706 | In distribution | ||
| 39713 | 40 | In distribution | |
| 44696 | 40 | In distribution | |
| 39715 | 36 | In distribution | |
| 77329 | 54 | In distribution | |
| 95201 | In distribution | ||
| 95101 | In distribution | ||
| 41739 | 40 | In distribution | |
| 46672 | 18 | In distribution | |
| 46669 | 19 | In distribution | |
| 44707 | In distribution | ||
| 11784 | In distribution | ||
| 44687 | In distribution | ||
| 44691 | In distribution | ||
| 46879 | In distribution | ||
| 44673 | In distribution | ||
| 99285 | In distribution | ||
| 90112 | In distribution | ||
| 44666 | 32 | In distribution | |
| 71627 | 48 | In distribution | |
| 44689 | In distribution | ||
| 41725 | 36 | In distribution | |
| 46883 | 14 | In distribution | |
| 79284 | 640 | In distribution | |
| 44680 | In distribution | ||
| 46874 | 12 | In distribution | |
| 44678 | In distribution | ||
| 41727 | 32 | In distribution | |
| 71626 | 60 | In distribution | |
| 90142 | In distribution | ||
| 44695 | In distribution | ||
| 44698 | 32 | In distribution | |
| 78042 | In distribution | ||
| 42621 | In distribution | ||
| 41928 | In distribution | ||
| 99287 | In distribution | ||
| 44679 | In distribution | ||
| 44663 | 42 | In distribution | |
| 44669 | 30 | In distribution | |
| 95511 | In distribution | ||
| 41733 | In distribution | ||
| 46866 | In distribution | ||
| 43941 | 36 | In distribution | |
| 44684 | In distribution | ||
| 95431 | In distribution | ||
| 33704 | In distribution | ||
| 95311 | In distribution | ||
| 95221 | In distribution | ||
| 90003 | In distribution | ||
| 88759 | In distribution | ||
| 44662 | 40 | In distribution | |
| 41882 | 32 | In distribution | |
| 44692 | In distribution | ||
| 41873 | In distribution | ||
| 33706 | In distribution | ||
| 47256 | 12 | In distribution | |
| 95021 | In distribution | ||
| 78921 | 36 | In distribution | |
| 74931 | 28 | In distribution | |
| 46869 | In distribution | ||
| 46864 | In distribution | ||
| 41933 | 36 | In distribution | |
| 90212 | In distribution | ||
| 71331 | 36 | In distribution | |
| 46670 | 18 | In distribution | |
| 79294 | 560 | In distribution | |
| 41726 | In distribution | ||
| 46878 | 14 | In distribution | |
| 74921 | 28 | In distribution | |
| 46876 | 16 | In distribution | |
| 44676 | In distribution | ||
| 78911 | 36 | In distribution | |
| 76531 | 28 | In distribution | |
| 79285 | 560 | In distribution | |
| 74115 | 48 | In distribution | |
| 44683 | In distribution | ||
| 41870 | In distribution | ||
| 74411 | 40 | In distribution | |
| 71311 | 40 | In distribution | |
| 95211 | In distribution | ||
| 74421 | 32 | In distribution | |
| 41929 | In distribution | ||
| 41934 | 32 | In distribution | |
| 46673 | In distribution | ||
| 46887 | 16 | In distribution | |
| 95411 | In distribution | ||
| 90048 | In distribution | ||
| 41872 | In distribution | ||
| 41738 | 36 | In distribution | |
| 46882 | In distribution | ||
| 44697 | 32 | In distribution | |
| 99294 | In distribution | ||
| 44681 | In distribution | ||
| 41736 | In distribution | ||
| 44693 | In distribution | ||
| 89791 | In distribution | ||
| 44661 | 36 | In distribution | |
| 44690 | In distribution | ||
| 41874 | In distribution | ||
| 46667 | In distribution | ||
| 72311 | 36 | In distribution | |
| 78221 | 40 | In distribution | |
| 43939 | In distribution | ||
| 47579 | In distribution | ||
| 41723 | 32 | In distribution | |
| 46885 | 12 | In distribution | |
| 46886 | 18 | In distribution | |
| 43938 | In distribution | ||
| 95121 | In distribution | ||
| 41740 | 32 | In distribution | |
| 46674 | In distribution | ||
| 41722 | 36 | In distribution | |
| 95531 | In distribution | ||
| 13337 | In distribution | ||
| 44664 | 32 | In distribution | |
| 45183 | 32 | In distribution | |
| 45181 | In distribution | ||
| 95521 | In distribution | ||
| 79295 | 560 | In distribution | |
| 99284 | In distribution | ||
| 70392 | 60 | In distribution | |
| 46865 | In distribution | ||
| 46873 | 12 | In distribution | |
| 79831 | 45 | In distribution | |
| 46868 | In distribution | ||
| 44688 | In distribution | ||
| 90018 | In distribution | ||
| 78211 | 44 | In distribution | |
| 41879 | 32 | In distribution | |
| 41735 | In distribution | ||
| 99288 | In distribution | ||
| 95321 | In distribution | ||
| 44674 | In distribution | ||
| 90012 | In distribution | ||
| 41931 | In distribution | ||
| 44667 | 36 | In distribution | |
| 46668 | In distribution | ||
| 41930 | In distribution | ||
| 95011 | In distribution | ||
| 41724 | In distribution | ||
| 74116 | 40 | In distribution | |
| 44677 | In distribution | ||
| 70391 | 66 | In distribution | |
| 44671 | 32 | In distribution | |
| 46877 | 16 | In distribution | |
| 90042 | In distribution | ||
| 46924 | 16 | In distribution | |
| 46875 | 18 | In distribution | |
| 46871 | 14 | In distribution | |
| 46884 | 14 | In distribution | |
| 95421 | In distribution | ||
| 13234 | 12 | In distribution | |
| 41871 | In distribution | ||
| 47346 | 10 | In distribution | |
| 44668 | 32 | In distribution | |
| 78039 | 60 | In distribution | |
| 33703 | In distribution | ||
| 44694 | In distribution | ||
| 41734 | In distribution | ||
| 41741 | 32 | In distribution | |
| 44672 | In distribution | ||
| 71321 | 36 | In distribution | |
| 43942 | In distribution | ||
| 46870 | 16 | In distribution | |
| 46671 | 18 | In distribution | |
| 78955 | In distribution | ||
| 13417 | Withdrawn | ||
| 92354 | Withdrawn | ||
| 41004 | Withdrawn | ||
| 92340 | Withdrawn | ||
| 46925 | 14 | Withdrawn | |
| 92320 | Withdrawn | ||
| 72448 | 32 | Withdrawn | |
| 72457 | 28 | Withdrawn | |
| 46926 | 14 | Withdrawn | |
| 92358 | Withdrawn | ||
| 73041 | 32 | Withdrawn | |
| 92347 | Withdrawn | ||
| 72447 | 32 | Withdrawn | |
| 78920 | Withdrawn | ||
| 13359 | Withdrawn | ||
| 92342 | Withdrawn | ||
| 72445 | 32 | Withdrawn | |
| 33705 | Withdrawn | ||
| 92038 | Withdrawn | ||
| 92331 | Withdrawn | ||
| 73038 | 36 | Withdrawn | |
| 92357 | Withdrawn | ||
| 91512 | 40 | Withdrawn | |
| 78930 | Withdrawn | ||
| 72454 | 40 | Withdrawn | |
| 72451 | 32 | Withdrawn | |
| 10550 | Withdrawn | ||
| 39716 | 36 | Withdrawn | |
| 92330 | Withdrawn | ||
| 41000 | Withdrawn | ||
| 92355 | Withdrawn | ||
| 92338 | Withdrawn | ||
| 92321 | Withdrawn | ||
| 92344 | Withdrawn | ||
| 35433 | Withdrawn | ||
| 10558 | Withdrawn | ||
| 88772 | Withdrawn | ||
| 92353 | Withdrawn | ||
| 92351 | Withdrawn | ||
| 10566 | Withdrawn | ||
| 39717 | 32 | Withdrawn | |
| 92042 | Withdrawn | ||
| 78925 | Withdrawn | ||
| 92323 | Withdrawn | ||
| 92333 | Withdrawn | ||
| 78012 | Withdrawn | ||
| 40989 | Withdrawn | ||
| 72453 | 28 | Withdrawn | |
| 40998 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 453 |
| Novo Health Services, LLC | Novo Health Services, LLC | 222 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 214 |
| Convertors | Cardinal Health 200, LLC | 184 |
| Lac-Mac | LAC-MAC Limited | 157 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 126 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 107 |
| ComPel Surgical Gown | Standard Textile Co., Inc. | 67 |
| Halyard | GRI Medical & Electronic Technology Co., Ltd. | 55 |
| ComPel MLR Surgical Gown | Standard Textile Co., Inc. | 38 |
| Medline Industries, Inc. | Medline Industries, Inc. | 35 |
| Cardinal Health | Cardinal Health 200, LLC | 35 |
Showing 12 of 172. All products under Gown, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210688 | 2021-07-21 |
| K200522 | 2020-03-16 |
| K192362 | 2019-12-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Owens & Minor Distribution, Inc. | UDI-DI | 2022-10-31 | Class II | Under Investigation by firm | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection | 72 cases (2160 pouches) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.