PremierPro
PremierPro Plus Improved Thinner Technology Nitrile Exam Glove X-Small 200count
48manufacturers in China registered for this device type
37catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (18), Guangdong (5), Hebei (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanxi Hongjin Plastic Technology Co., Ltd. | Linfen | Shanxi | Contract manufacturer | 5 |
| 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 |
| Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| 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 |
Showing 12 of 48. All 48 manufacturers in China registered for Medical Glove, Specialty
Record
| Listed by | Prestige Ameritech, United States |
|---|---|
| FDA product code | LZC |
| Device type | Medical Glove, Specialty |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-03-08 |
| Record revised | 2026-08-03 (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, box of 50, box of 100 |
| Distribution end date | 2023-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D5064 | In distribution | |
| 5004 | In distribution | |
| 5045 | In distribution | |
| 5064 | In distribution | |
| 5043 | In distribution | |
| 5044 | In distribution | |
| 5084 | In distribution | |
| 5003 | In distribution | |
| 5042 | In distribution | |
| D5065 | In distribution | |
| 5093 | In distribution | |
| 5073 | In distribution | |
| 5062 | In distribution | |
| 5061 | In distribution | |
| 5002 | In distribution | |
| 5074 | In distribution | |
| 5082 | In distribution | |
| 5065 | In distribution | |
| D5061 | In distribution | |
| 5041 | In distribution | |
| 5095 | In distribution | |
| 5063 | In distribution | |
| D5062 | In distribution | |
| 5005 | In distribution | |
| 5072 | In distribution | |
| 5085 | In distribution | |
| 5094 | In distribution | |
| 5075 | In distribution | |
| 5083 | In distribution | |
| 5092 | In distribution | |
| 5001 | In distribution | |
| D5063 | In distribution | |
| D5064 | Withdrawn | |
| D5063 | Withdrawn | |
| D5065 | Withdrawn | |
| D5062 | Withdrawn | |
| D5061 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | O&M Halyard, Inc. | 119 |
| Europapa | Europapa Handels GmbH | 40 |
| Tronex International, Inc. | Tronex International, Inc. | 37 |
| Medicom AssureTouch | AMD Medicom Inc. | 29 |
| Ocean Pacific | AMD Medicom Inc. | 25 |
| MediChoice | Owens & Minor Distribution, Inc. | 24 |
| FreeStyle | Hourglass International Inc | 22 |
| Novaplus | Cardinal Health 200, LLC | 21 |
| Scion | Hourglass International Inc | 20 |
| Cardinal Health | Cardinal Health 200, LLC | 18 |
| Flexal | Cardinal Health 200, LLC | 18 |
| Ammex Professional | Ammex Corporation | 18 |
Showing 12 of 174. All products under Medical Glove, Specialty
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| SVS LLC | UDI-DI | 2024-05-13 | Class II | Under Investigation by firm | Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another | 155,540 inner boxes |
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.