Halyard
HALYARD BASICS* BlueViolet Powder-Free Nitrile Exam Glove, LRG
83manufacturers in China registered for this device type
120catalogue numbers in this listing
14510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (27), Guangdong (10), Jiangsu (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| YUE Kang Anhui Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| Opus Gloves Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Better Care Plastic Technology Co., Ltd. | Shenze County | Hebei | Contract manufacturer | 4 |
| Xingyu Medical Tech Co., Ltd. | Weifang | Shandong | Contract manufacturer | 4 |
| Lingshi Hongruida Health Protection Technology Co., Ltd. | Jinzhong | Shanxi | Contract manufacturer | 4 |
| Zhangjiagang Blackbox Plastic Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Xuzhou Full Sun Medical Products Ltd. | Pizhou | Jiangsu | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Anhui Kindguard Medical Supplies Technology Co., Ltd. | Suzhou | Anhui | Contract manufacturer | 2 |
| Puyang Linshi Medical Supplies Co., Ltd. | Puyang | Henan | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Showing 12 of 83. All 83 manufacturers in China registered for Polymer Patient Examination Glove
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | LZA |
| Device type | Polymer Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K081260 |
| Record published | 2020-09-15 |
| Record revised | 2026-03-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 4, case of 16, dsp of 50, case of 20, dsp of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47189 | 200 | In distribution | |
| 47028 | 50 | In distribution | |
| 48800 | 100 | In distribution | |
| 44912 | 230 | In distribution | |
| 50967 | 200 | In distribution | |
| 55033 | 100 | In distribution | |
| 45271 | 100 | In distribution | |
| 33031 | In distribution | ||
| 49441 | 1,000 | In distribution | |
| 45275 | 250 | In distribution | |
| 49642 | 100 | In distribution | |
| 47027 | 50 | In distribution | |
| 47461 | 200 | In distribution | |
| 48775 | 23 | In distribution | |
| 44758 | 150 | In distribution | |
| 49729 | 100 | In distribution | |
| 45269 | 100 | In distribution | |
| 47016 | 100 | In distribution | |
| 53131 | 2 | In distribution | |
| 48771 | 25 | In distribution | |
| 47459 | 200 | In distribution | |
| 55031 | 100 | In distribution | |
| 47018 | 100 | In distribution | |
| 53100 | 100 | In distribution | |
| 55034 | 90 | In distribution | |
| 45297 | 100 | In distribution | |
| 47191 | 170 | In distribution | |
| 53102 | 100 | In distribution | |
| 53104 | 90 | In distribution | |
| 50852 | 500 | In distribution | |
| 45268 | 100 | In distribution | |
| 49732 | 100 | In distribution | |
| 45258 | 150 | In distribution | |
| 50705 | 200 | In distribution | |
| 47463 | 170 | In distribution | |
| 45276 | 250 | In distribution | |
| 47462 | 200 | In distribution | |
| 48952 | 90 | In distribution | |
| 45259 | 150 | In distribution | |
| 47029 | 50 | In distribution | |
| 48753 | 200 | In distribution | |
| 44908 | 250 | In distribution | |
| 53430 | 100 | In distribution | |
| 44795 | 200 | In distribution | |
| 50034 | 90 | In distribution | |
| 50033 | 100 | In distribution | |
| 45277 | 250 | In distribution | |
| 33027 | In distribution | ||
| 53434 | 90 | In distribution | |
| 33024 | 2 | In distribution | |
| 48765 | 50 | In distribution | |
| 44759 | 140 | In distribution | |
| 44792 | 200 | In distribution | |
| 45299 | 100 | In distribution | |
| 48773 | 25 | In distribution | |
| 45279 | 230 | In distribution | |
| 45272 | 90 | In distribution | |
| 49644 | 100 | In distribution | |
| 49439 | 1,000 | In distribution | |
| 45296 | 100 | In distribution | |
| 44794 | 200 | In distribution | |
| 50964 | 200 | In distribution | |
| 48774 | 25 | In distribution | |
| 45298 | 100 | In distribution | |
| 53132 | 2 | In distribution | |
| 45257 | 150 | In distribution | |
| 55030 | 100 | In distribution | |
| 49641 | 100 | In distribution | |
| 47031 | 50 | In distribution | |
| 49731 | 100 | In distribution | |
| 53130 | 2 | In distribution | |
| 44796 | 180 | In distribution | |
| 53432 | 100 | In distribution | |
| 48772 | 25 | In distribution | |
| 33028 | In distribution | ||
| 48752 | 200 | In distribution | |
| 44909 | 250 | In distribution | |
| 53101 | 100 | In distribution | |
| 49730 | 100 | In distribution | |
| 47019 | 90 | In distribution | |
| 44793 | 200 | In distribution | |
| 50966 | 200 | In distribution | |
| 44910 | 250 | In distribution | |
| 47017 | 100 | In distribution | |
| 47460 | 200 | In distribution | |
| 44756 | 150 | In distribution | |
| 50032 | 100 | In distribution | |
| 48766 | 100 | In distribution | |
| 53433 | 100 | In distribution | |
| 50238 | 250 | In distribution | |
| 50031 | 100 | In distribution | |
| 49442 | 1,000 | In distribution | |
| 45278 | 250 | In distribution | |
| 50965 | 200 | In distribution | |
| 48798 | 100 | In distribution | |
| 33025 | 2 | In distribution | |
| 47188 | 200 | In distribution | |
| 33029 | In distribution | ||
| 50968 | 180 | In distribution | |
| 49440 | 1,000 | In distribution | |
| 53431 | 100 | In distribution | |
| 45270 | 100 | In distribution | |
| 47030 | 50 | In distribution | |
| 44755 | 150 | In distribution | |
| 53103 | 100 | In distribution | |
| 45300 | 90 | In distribution | |
| 50709 | 170 | In distribution | |
| 47015 | 100 | In distribution | |
| 49643 | 100 | In distribution | |
| 33026 | 2 | In distribution | |
| 33030 | In distribution | ||
| 55032 | 100 | In distribution | |
| 44757 | 150 | In distribution | |
| 45260 | 140 | In distribution | |
| 49443 | 1,000 | In distribution | |
| 49645 | 90 | In distribution | |
| 47190 | 200 | In distribution | |
| 44911 | 250 | In distribution | |
| 45256 | 150 | In distribution | |
| 49728 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 255 |
| Microflex | Ansell Healthcare Product | 185 |
| FifthPulse | Jeg & Sons Inc. | 135 |
| SW | SW Safety Solutions Inc. | 130 |
| Basic | Intco Medical Industries, Inc. | 119 |
| Cranberry | Ascend Eagle, Inc. | 109 |
| 1st Choice | Ammex Corporation | 101 |
| JMU | JMU Dental, Inc | 90 |
| Vivit Supply | Vivit Supply LLC | 86 |
| McKesson | Mckesson Medical-Surgical Inc. | 75 |
| Natural Extensions | Benco Dental Supply Co. | 74 |
| Condor | Grainger International, Inc. | 72 |
Showing 12 of 930. All products under Polymer Patient Examination Glove
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262014 | 2026-07-21 |
| K243604 | 2025-08-18 |
| K243172 | 2025-06-18 |
| K242558 | 2024-12-17 |
| K241909 | 2024-09-27 |
| K231938 | 2024-03-22 |
| K213937 | 2022-08-16 |
| K213929 | 2022-08-01 |
| K220547 | 2022-06-02 |
| K220541 | 2022-06-02 |
| K211063 | 2021-11-19 |
| K202622 | 2021-01-07 |
| K200843 | 2020-09-22 |
| K182851 | 2019-06-26 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| O&M Halyard, Inc. | UDI-DI | 2026-04-13 | Class II | Under Investigation by firm | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | 452,500 units | |
| O&M Halyard, Inc. | UDI-DI | 2021-09-27 | Class II | Component design/selection | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. | 2,928 cases (5,856,000 gloves) | |
| Halyard Health, Inc. | 510(k) number | 2016-11-10 | Class II | Under Investigation by firm | Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing. | 59 cases | 2017-05-04 |
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.