Halyard
Ultra Fabric-Reinforced Surgical Gown, Large, X-Long, with Neck Protection and Thumb Loops, with Towel
39manufacturers in China registered for this device type
800catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 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 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K083234 |
| Record published | 2015-12-04 |
| Record revised | 2024-07-09 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10, case of 10, case of 5, case of 9, case of 12, pack of 8 |
| Distribution end date | 2024-05-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 77457 | In distribution | ||
| 44175 | In distribution | ||
| 44249 | In distribution | ||
| 77506 | In distribution | ||
| 88875 | In distribution | ||
| 77383 | In distribution | ||
| 89233 | In distribution | ||
| 88621 | In distribution | ||
| 88412 | In distribution | ||
| 79465 | 6 | In distribution | |
| 88222 | In distribution | ||
| 88769 | In distribution | ||
| 88226 | In distribution | ||
| 77510 | In distribution | ||
| 89453 | In distribution | ||
| 79375 | 28 | In distribution | |
| 86307 | 1,120 | In distribution | |
| 79784 | 120 | In distribution | |
| 89421 | In distribution | ||
| 89221 | In distribution | ||
| 89466 | In distribution | ||
| 88271 | In distribution | ||
| 89279 | In distribution | ||
| 89583 | In distribution | ||
| 89672 | In distribution | ||
| 88888 | In distribution | ||
| 34822 | In distribution | ||
| 33415 | In distribution | ||
| 88711 | In distribution | ||
| 77424 | In distribution | ||
| 79380 | 16 | In distribution | |
| 44965 | 100 | In distribution | |
| 89272 | In distribution | ||
| 89119 | In distribution | ||
| 72888 | 48 | In distribution | |
| 89333 | In distribution | ||
| 79525 | 14 | In distribution | |
| 88773 | In distribution | ||
| 77910 | In distribution | ||
| 88735 | In distribution | ||
| 77794 | In distribution | ||
| 90781 | In distribution | ||
| 07025 | In distribution | ||
| 41150 | In distribution | ||
| 77503 | In distribution | ||
| 89191 | In distribution | ||
| 07865 | In distribution | ||
| 29249 | In distribution | ||
| 14208 | In distribution | ||
| 38827 | In distribution | ||
| 79746 | 160 | In distribution | |
| 76134 | In distribution | ||
| 79408 | 70 | In distribution | |
| 89705 | In distribution | ||
| 77913 | In distribution | ||
| 76216 | In distribution | ||
| 89731 | In distribution | ||
| 89343 | In distribution | ||
| 90747 | In distribution | ||
| 90795 | In distribution | ||
| 38866 | In distribution | ||
| 77175 | 50 | In distribution | |
| 79349 | 10 | In distribution | |
| 89293 | 80 | In distribution | |
| 35795 | In distribution | ||
| 89472 | In distribution | ||
| 14252 | In distribution | ||
| 39836 | In distribution | ||
| 79561 | 20 | In distribution | |
| 88886 | In distribution | ||
| 88631 | In distribution | ||
| 07568 | In distribution | ||
| 89304 | In distribution | ||
| 41983 | In distribution | ||
| 88900 | In distribution | ||
| 79222 | 22 | In distribution | |
| 44975 | 6 | In distribution | |
| 88618 | In distribution | ||
| 89371 | In distribution | ||
| 79597 | 35 | In distribution | |
| 05018 | In distribution | ||
| 29155 | In distribution | ||
| 77331 | In distribution | ||
| 79980 | 36 | In distribution | |
| 30805 | In distribution | ||
| 88424 | In distribution | ||
| 88660 | In distribution | ||
| 77779 | In distribution | ||
| 89051 | 6 | In distribution | |
| 90779 | In distribution | ||
| 77729 | In distribution | ||
| 77776 | In distribution | ||
| 89537 | In distribution | ||
| 35585 | In distribution | ||
| 79790 | 35 | In distribution | |
| 79490 | 12 | In distribution | |
| 77785 | In distribution | ||
| 89093 | In distribution | ||
| 44978 | In distribution | ||
| 79255 | 18 | In distribution | |
| 88885 | In distribution | ||
| 89686 | In distribution | ||
| 88111 | In distribution | ||
| 31188 | In distribution | ||
| 79538 | 26 | In distribution | |
| 79330 | 115 | In distribution | |
| 88253 | In distribution | ||
| 88765 | In distribution | ||
| 89602 | In distribution | ||
| 66510 | In distribution | ||
| 90690 | In distribution | ||
| 48976 | 120 | In distribution | |
| 89601 | In distribution | ||
| 77880 | In distribution | ||
| 44974 | In distribution | ||
| 79466 | 6 | In distribution | |
| 88883 | In distribution | ||
| 79571 | 32 | In distribution | |
| 79709 | 16 | In distribution | |
| 79097 | 200 | In distribution | |
| 79363 | 15 | In distribution | |
| 77530 | In distribution | ||
| 89206 | In distribution | ||
| 05202 | In distribution | ||
| 89354 | In distribution | ||
| 89704 | In distribution | ||
| 77385 | In distribution | ||
| 37498 | In distribution | ||
| 88108 | In distribution | ||
| 47181 | In distribution | ||
| 76375 | 15 | In distribution | |
| 79593 | 24 | In distribution | |
| 77914 | In distribution | ||
| 42309 | In distribution | ||
| 44970 | In distribution | ||
| 77450 | In distribution | ||
| 77594 | In distribution | ||
| 89045 | 4 | In distribution | |
| 89471 | In distribution | ||
| 88100 | In distribution | ||
| 89358 | In distribution | ||
| 41263 | In distribution | ||
| 88439 | In distribution | ||
| 77491 | In distribution | ||
| 88171 | In distribution | ||
| 90666 | In distribution | ||
| 79224 | 10 | In distribution | |
| 89431 | In distribution | ||
| 88904 | In distribution | ||
| 89687 | In distribution | ||
| 29258 | In distribution | ||
| 79692 | 120 | In distribution | |
| 47179 | In distribution | ||
| 44247 | In distribution | ||
| 66886 | In distribution | ||
| 88763 | In distribution | ||
| 05706 | In distribution | ||
| 79319 | 40 | In distribution | |
| 79482 | 90 | In distribution | |
| 77455 | In distribution | ||
| 77919 | In distribution | ||
| 79545 | 20 | In distribution | |
| 77917 | In distribution | ||
| 40512 | In distribution | ||
| 88782 | In distribution | ||
| 79697 | 500 | In distribution | |
| 41134 | In distribution | ||
| 90686 | In distribution | ||
| 88411 | In distribution | ||
| 88354 | In distribution | ||
| 89265 | In distribution | ||
| 79696 | 40 | In distribution | |
| 89671 | In distribution | ||
| 79787 | 35 | In distribution | |
| 89227 | In distribution | ||
| 59704 | In distribution | ||
| 42345 | In distribution | ||
| 90689 | In distribution | ||
| 07756 | In distribution | ||
| 29236 | In distribution | ||
| 77902 | In distribution | ||
| 90748 | In distribution | ||
| 88441 | In distribution | ||
| 79335 | 22 | In distribution | |
| 07515 | In distribution | ||
| 38864 | In distribution | ||
| 29221 | In distribution | ||
| 88841 | In distribution | ||
| 43068 | In distribution | ||
| 79233 | 18 | In distribution | |
| 88716 | In distribution | ||
| 79810 | 90 | In distribution | |
| 29240 | In distribution | ||
| 34902 | In distribution | ||
| 79754 | 120 | In distribution | |
| 77904 | In distribution | ||
| 77574 | In distribution | ||
| 89525 | In distribution | ||
| 77691 | In distribution | ||
| 79861 | 90 | In distribution | |
| 90673 | In distribution | ||
| 47061 | In distribution | ||
| 77784 | In distribution | ||
| 88910 | In distribution | ||
| 89682 | In distribution | ||
| 88223 | In distribution | ||
| 29232 | In distribution | ||
| 89528 | In distribution | ||
| 76271 | In distribution | ||
| 42274 | In distribution | ||
| 77748 | In distribution | ||
| 39600 | In distribution | ||
| 42306 | In distribution | ||
| 77911 | In distribution | ||
| 79745 | 30 | In distribution | |
| 79279 | 5 | In distribution | |
| 41231 | In distribution | ||
| 41089 | In distribution | ||
| 40992 | In distribution | ||
| 89223 | In distribution | ||
| 90787 | In distribution | ||
| 79595 | 120 | In distribution | |
| 89529 | In distribution | ||
| 79390 | 40 | In distribution | |
| 88300 | In distribution | ||
| 88203 | In distribution | ||
| 79492 | 15 | In distribution | |
| 29149 | In distribution | ||
| 89749 | In distribution | ||
| 77717 | In distribution | ||
| 88213 | In distribution | ||
| 41809 | In distribution | ||
| 44968 | In distribution | ||
| 44789 | In distribution | ||
| 77865 | In distribution | ||
| 90019 | In distribution | ||
| 77265 | In distribution | ||
| 07606 | In distribution | ||
| 07831 | In distribution | ||
| 37501 | In distribution | ||
| 89415 | In distribution | ||
| 88233 | In distribution | ||
| 89124 | In distribution | ||
| 77916 | In distribution | ||
| 89208 | In distribution | ||
| 77571 | In distribution | ||
| 88421 | In distribution | ||
| 43334 | In distribution | ||
| 77908 | In distribution | ||
| 77798 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 994 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 819 |
| Medline | Medline Industries, Inc. | 517 |
| Convertors | Cardinal Health 200, LLC | 392 |
| Medline Industries, Inc. | Medline Industries, Inc. | 274 |
| TIDIShield | Tidi Products, LLC | 187 |
| DeRoyal | Deroyal Industries, Inc. | 118 |
| Cardinal Health | Cardinal Health 200, LLC | 111 |
| Angiosystems Drape | Angiosystems, Inc. | 109 |
| ComPel Surgical Drape | Standard Textile Co., Inc. | 101 |
| Drape, Surgical, Antimicrobial | Welmed, Inc. | 95 |
| Novo Health Services, LLC | Novo Health Services, LLC | 90 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| O&M Halyard, Inc. | 510(k) number | 2025-07-17 | Class II | Process control | Surgical drape packs may have open seals, which may compromise the sterility of the product. | 1316 | |
| O&M Halyard, Inc. | 510(k) number | 2024-11-26 | Class II | Process control | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. | 1440 units | |
| Kimberly-Clark Corporation | 510(k) number | 2012-07-05 | Class II | Packaging process control | Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. | 89,856 (28 units per case) | 2013-06-13 |
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.