Henry Schein
Criterion N300 Electric Blue XS
29manufacturers in China registered for this device type
5catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | QDO |
| Device type | Fentanyl And Other Opioid Protection Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Premarket notification | Exempt |
| Record published | 2024-03-25 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5703543 | 300 | In distribution | |
| 5703540 | 300 | In distribution | |
| 5703490 | 200 | In distribution | |
| 5703541 | 300 | In distribution | |
| 5703541 | 300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Home Green Leaf | Uniware Houseware Corp. | 16 |
| Halyard | O&M Halyard, Inc. | 13 |
| 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 |
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.