Halyard
HALYARD ARMOR-FLEX, HEAVY-FLEX, STANDARD-FLEX and H300W wraps with ASSURE-DRY technology are used to enclose another medical device for sterilization by a healthcare provider. The source…
HALYARD ARMOR-FLEX, HEAVY-FLEX, STANDARD-FLEX and H300W wraps with ASSURE-DRY technology are used to enclose another medical device for sterilization by a healthcare provider.
The source identifies pre-vacuum steam sterilization and describes a moisture-managing amber layer as part of the wrap system.
Listed Item
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 45in. X 45in. (114cm X 114cm)
Wrap Layers and Cycles
The wrap uses blue and amber layers. The amber moisture-managing layer may be positioned inside for a 20-minute dry time or outside for a 30-minute dry time.
38manufacturers in China registered for this device type
191catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (9), Shanghai (5). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Wuhan Zonsen Medical Products Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 24 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Binzhou Dingyue Clothing Company Limited | Binzhou | Shandong | Contract manufacturer | 7 |
Showing 12 of 38. All 38 manufacturers in China registered for Wrap, Sterilization
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K261897 |
| Record published | 2016-03-02 |
| Record revised | 2023-01-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 2, case of 3, case of 5, case of 4, case, case of 10 |
| Sizes | Width 30 in |
| Distribution end date | 2023-01-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10845 | 50 | In distribution | |
| 34151 | 36 | In distribution | |
| 49766 | 20 | In distribution | |
| 34180 | 144 | In distribution | |
| 49768 | 20 | In distribution | |
| 10872 | 50 | In distribution | |
| 78045 | 50 | In distribution | |
| 68636 | 72 | In distribution | |
| 37047 | 100 | In distribution | |
| 78054 | 50 | In distribution | |
| 10840 | 50 | In distribution | |
| 68172 | 50 | In distribution | |
| 68248 | 50 | In distribution | |
| 34187 | 24 | In distribution | |
| 14277 | 12 | In distribution | |
| 10772 | 50 | In distribution | |
| 34186 | 24 | In distribution | |
| 68648 | 48 | In distribution | |
| 10830 | 100 | In distribution | |
| 34173 | 48 | In distribution | |
| 68018 | 500 | In distribution | |
| 10720 | 500 | In distribution | |
| 68672 | 24 | In distribution | |
| 68072 | 50 | In distribution | |
| 37050 | 100 | In distribution | |
| 14281 | 12 | In distribution | |
| 68230 | 50 | In distribution | |
| 78036 | 150 | In distribution | |
| 10740 | 50 | In distribution | |
| 14324 | 24 | In distribution | |
| 34170 | 240 | In distribution | |
| 34181 | 24 | In distribution | |
| 34200 | 24 | In distribution | |
| 68148 | 50 | In distribution | |
| 10818 | 500 | In distribution | |
| 34147 | 24 | In distribution | |
| 34164 | 24 | In distribution | |
| 34142 | 24 | In distribution | |
| 34163 | 24 | In distribution | |
| 68130 | 125 | In distribution | |
| 34171 | 120 | In distribution | |
| 10736 | 150 | In distribution | |
| 68024 | 250 | In distribution | |
| 68272 | 50 | In distribution | |
| 34198 | 24 | In distribution | |
| 34196 | 12 | In distribution | |
| 14271 | 12 | In distribution | |
| 34162 | 60 | In distribution | |
| 10718 | 500 | In distribution | |
| 14313 | 12 | In distribution | |
| 34179 | 12 | In distribution | |
| 34174 | 120 | In distribution | |
| 49763 | 48 | In distribution | |
| 34178 | 120 | In distribution | |
| 34161 | 24 | In distribution | |
| 34190 | 24 | In distribution | |
| 34195 | 12 | In distribution | |
| 78030 | 150 | In distribution | |
| 34194 | 48 | In distribution | |
| 14279 | 12 | In distribution | |
| 78048 | 50 | In distribution | |
| 68154 | 50 | In distribution | |
| 68640 | 48 | In distribution | |
| 14320 | 12 | In distribution | |
| 68218 | 300 | In distribution | |
| 10754 | 50 | In distribution | |
| 34185 | 48 | In distribution | |
| 34191 | 12 | In distribution | |
| 68036 | 100 | In distribution | |
| 68048 | 50 | In distribution | |
| 37049 | 100 | In distribution | |
| 34172 | 24 | In distribution | |
| 34199 | 36 | In distribution | |
| 68040 | 50 | In distribution | |
| 68240 | 50 | In distribution | |
| 34160 | 48 | In distribution | |
| 10824 | 250 | In distribution | |
| 34167 | 240 | In distribution | |
| 34154 | 240 | In distribution | |
| 14268 | 12 | In distribution | |
| 10836 | 100 | In distribution | |
| 34183 | 60 | In distribution | |
| 68030 | 100 | In distribution | |
| 34156 | 240 | In distribution | |
| 34158 | 36 | In distribution | |
| 34165 | 60 | In distribution | |
| 10848 | 50 | In distribution | |
| 34149 | 24 | In distribution | |
| 68015 | 500 | In distribution | |
| 10745 | 50 | In distribution | |
| 10724 | 250 | In distribution | |
| 14275 | 12 | In distribution | |
| 68118 | 300 | In distribution | |
| 34148 | 24 | In distribution | |
| 68190 | 25 | In distribution | |
| 68254 | 50 | In distribution | |
| 68136 | 75 | In distribution | |
| 34193 | 240 | In distribution | |
| 34182 | 24 | In distribution | |
| 34192 | 240 | In distribution | |
| 37051 | 100 | In distribution | |
| 68236 | 75 | In distribution | |
| 34145 | 24 | In distribution | |
| 34176 | 48 | In distribution | |
| 68245 | 50 | In distribution | |
| 34197 | 12 | In distribution | |
| 68145 | 50 | In distribution | |
| 34168 | 24 | In distribution | |
| 68160 | 25 | In distribution | |
| 68654 | 48 | In distribution | |
| 10715 | 500 | In distribution | |
| 34184 | 24 | In distribution | |
| 68645 | 48 | In distribution | |
| 34189 | 24 | In distribution | |
| 34157 | 24 | In distribution | |
| 78024 | 250 | In distribution | |
| 37045 | 144 | In distribution | |
| 10854 | 50 | In distribution | |
| 10712 | 500 | In distribution | |
| 68124 | 125 | In distribution | |
| 68224 | 125 | In distribution | |
| 10748 | 50 | In distribution | |
| 12818 | 240 | In distribution | |
| 34188 | 24 | In distribution | |
| 68012 | 500 | In distribution | |
| 49765 | 20 | In distribution | |
| 49764 | 30 | In distribution | |
| 37044 | 240 | In distribution | |
| 34143 | 24 | In distribution | |
| 34159 | 24 | In distribution | |
| 14309 | 12 | In distribution | |
| 37046 | 100 | In distribution | |
| 34146 | 24 | In distribution | |
| 49767 | 20 | In distribution | |
| 10730 | 150 | In distribution | |
| 68054 | 50 | In distribution | |
| 34175 | 48 | In distribution | |
| 12724 | 120 | Withdrawn | |
| 62672 | 12 | Withdrawn | |
| 62254 | 24 | Withdrawn | |
| 62154 | 24 | Withdrawn | |
| 62018 | 240 | Withdrawn | |
| 62148 | 24 | Withdrawn | |
| 12712 | 240 | Withdrawn | |
| 62145 | 24 | Withdrawn | |
| 62072 | 24 | Withdrawn | |
| 62048 | 24 | Withdrawn | |
| 62012 | 240 | Withdrawn | |
| 62172 | 12 | Withdrawn | |
| 12715 | 240 | Withdrawn | |
| 62136 | 36 | Withdrawn | |
| 62015 | 240 | Withdrawn | |
| 62190 | 12 | Withdrawn | |
| 62036 | 48 | Withdrawn | |
| 12730 | 48 | Withdrawn | |
| 62636 | 36 | Withdrawn | |
| 62648 | 24 | Withdrawn | |
| 62124 | 60 | Withdrawn | |
| 12830 | 48 | Withdrawn | |
| 62224 | 60 | Withdrawn | |
| 12718 | 240 | Withdrawn | |
| 12840 | 24 | Withdrawn | |
| 62040 | 24 | Withdrawn | |
| 12854 | 24 | Withdrawn | |
| 12745 | 24 | Withdrawn | |
| 62160 | 12 | Withdrawn | |
| 62245 | 24 | Withdrawn | |
| 37159 | 100 | Withdrawn | |
| 62240 | 24 | Withdrawn | |
| 62030 | Width 30 in | 48 | Withdrawn |
| 12754 | 24 | Withdrawn | |
| 12848 | 24 | Withdrawn | |
| 12748 | 24 | Withdrawn | |
| 62640 | 24 | Withdrawn | |
| 12720 | 240 | Withdrawn | |
| 12836 | 48 | Withdrawn | |
| 62645 | 24 | Withdrawn | |
| 62024 | 120 | Withdrawn | |
| 62248 | 24 | Withdrawn | |
| 12872 | 24 | Withdrawn | |
| 62130 | 60 | Withdrawn | |
| 12845 | 24 | Withdrawn | |
| 62054 | 24 | Withdrawn | |
| 10709 | 500 | Withdrawn | |
| 62654 | 24 | Withdrawn | |
| 12736 | 48 | Withdrawn | |
| 62118 | 144 | Withdrawn | |
| 12740 | 24 | Withdrawn | |
| 62272 | 12 | Withdrawn | |
| 12824 | 120 | Withdrawn | |
| 62236 | 36 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 824 |
| Cardinal Health | Cardinal Health 200, LLC | 333 |
| Arjo Wiggins Medical, Inc. | Sterimed, Inc. | 286 |
| Primed | Primed Medical Products Inc. | 154 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 148 |
| Vivit Supply | Vivit Supply LLC | 103 |
| Case Medical | Case Medical, Inc. | 103 |
| Gemini | Medline Industries, Inc. | 89 |
| CareGUARD | Care Essentials PTY Ltd | 72 |
| Halyard | Owens & Minor Distribution, Inc. | 70 |
| Wrap, Sterilization | Steris Corporation | 69 |
| Medical Action Industries | Medical Action Industries, Inc. | 58 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261897 | 2026-07-02 |
| K253454 | 2026-05-18 |
| K234050 | 2024-09-16 |
| K240330 | 2024-08-07 |
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.