Halyard
Lavender* Nitrile Powder-Free Exam Gloves, XL
29manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (11), Guangdong (4), Hubei (3). 6 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 Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
| Xiamen Firstcare IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Exporter | 40 |
| Gauke (Hubei) Healthcare Co., Ltd. | Huanggang | Hubei | Contract manufacturer | 36 |
| Gauke International Trading Co., Ltd. | Wuhan | Hubei | Repacker / relabeller | 36 |
Showing 12 of 29. All 29 manufacturers in China registered for Fentanyl And Other Opioid Protection Glove
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | QDO |
| Device type | Fentanyl And Other Opioid Protection Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K220547 |
| Record published | 2026-06-04 |
| Record revised | 2025-10-02 (version 2) |
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 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 50071 | 230 | In distribution | |
| 48768 | 100 | In distribution | |
| 50069 | 250 | In distribution | |
| 48801 | 100 | In distribution | |
| 48763 | 50 | In distribution | |
| 48761 | 50 | In distribution | |
| 48764 | 50 | In distribution | |
| 48769 | 100 | In distribution | |
| 48797 | 100 | In distribution | |
| 50068 | 250 | In distribution | |
| 48762 | 50 | In distribution | |
| 50067 | 250 | In distribution | |
| 48754 | 170 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Home Green Leaf | Uniware Houseware Corp. | 16 |
| HCS | Concordance Healthcare Solutions LLC | 12 |
| Icon Certo | Excel Gloves & Safety Supplies, Inc. | 10 |
| Excel | Excel Gloves & Safety Supplies, Inc. | 10 |
| Get-A-Grip | Summit Glove, Inc. | 10 |
| American Health and Safety | Labsource, Inc | 8 |
| Medisca Safe-Sense | Medisca Inc. | 8 |
| HCS | Dyad Medical Sourcing, LLC | 8 |
| Curaplex | Bound Tree Medical, LLC | 7 |
| Intercept Free | P H & S Products LLC | 7 |
| Icon | Excel Gloves & Safety Supplies, Inc. | 6 |
| Icon Boom | Excel Gloves & Safety Supplies, Inc. | 5 |
Showing 12 of 58. All products under Fentanyl And Other Opioid Protection Glove
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.