Sleeve
Sleeve - Slip On .25mm Xenolite 800 NL Size X-Small
78manufacturers in China registered for this device type
51catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Jiangsu (13), Guangdong (10). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
| Honghu Danielle Sanitary Material Co., Ltd. | Honghu | Hubei | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Gushi County | Henan | Contract manufacturer | 9 |
| Wenzhou Weilan Optical Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 8 |
| priMED Jiujiang Medical Products Manufacturing Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 7 |
| Skytech Electronics (HK) Limited | Tsim Sha Tsui | Hong Kong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Showing 12 of 78. All 78 manufacturers in China registered for Shield, Protective, Personnel
Record
| Listed by | Burlington Medical, LLC, United States |
|---|---|
| FDA product code | KPY |
| Device type | Shield, Protective, Personnel |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ULSL3-XS | In distribution | |
| ULSL3-SM | In distribution | |
| S8SL | In distribution | |
| RLSL3-MD | In distribution | |
| SBSL3-SM | In distribution | |
| R8SL | In distribution | |
| SLSL3-MD | In distribution | |
| RBSL | In distribution | |
| SBSL3-MD | In distribution | |
| U8SL3-SM | In distribution | |
| UBSL | In distribution | |
| SLSL3-XS | In distribution | |
| S8SL3-LG | In distribution | |
| SLSL3-XL | In distribution | |
| ULSL3-MD | In distribution | |
| UBL3-XL | In distribution | |
| UBSL3-LG | In distribution | |
| UBSL3-XS | In distribution | |
| R8SL3-SM | In distribution | |
| ULSL | In distribution | |
| RLSL3-SM | In distribution | |
| R8SL3-LG | In distribution | |
| RBSL3-XS | In distribution | |
| RBL3-XL | In distribution | |
| RBSL3-LG | In distribution | |
| RLL3-LG | In distribution | |
| SBSL3-XS | In distribution | |
| SLSL3-SM | In distribution | |
| SBSL3-LG | In distribution | |
| SBL3-XL | In distribution | |
| UBSL3-MD | In distribution | |
| U8SL3-LG | In distribution | |
| U8SL3-XS | In distribution | |
| ULSL3-XL | In distribution | |
| RBSL3-SM | In distribution | |
| S8SL3-MD | In distribution | |
| SBSL | In distribution | |
| ULSL3-LG | In distribution | |
| RBSL3-MD | In distribution | |
| R8SL3-XS | In distribution | |
| R8SL3-MD | In distribution | |
| U8SL | In distribution | |
| RLSL3-XL | In distribution | |
| UBSL3-SM | In distribution | |
| S8SL3-SM | In distribution | |
| SLL3-LG | In distribution | |
| RLSL3-XS | In distribution | |
| SLSL | In distribution | |
| S8SL3-XS | In distribution | |
| RLSL | In distribution | |
| U8SL3-MD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenex | Kenex (Electro-Medical) Ltd. | 163 |
| Bloxr | Bloxr Solutions LLC | 125 |
| Aadco | Aadco Medical, Inc. | 104 |
| UT | Mavig Gmbh | 87 |
| CAP | Burlington Medical, LLC | 66 |
| Radpad | Worldwide Innovations & Technologies, Inc. | 59 |
| AngioSystems SorbX | Angiosystems, Inc. | 52 |
| Lead Lined | Biodex Medical Systems, Inc. | 40 |
| Molded Products, Inc. | Molded Products Inc. | 34 |
| MasterPeace | Texray AB | 30 |
| Halyard Scatter Radiation Shields | Angiosystems, Inc. | 30 |
| Leg Wrap | Burlington Medical, LLC | 24 |
Showing 12 of 134. All products under Shield, Protective, Personnel
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 |
|---|---|---|---|---|---|---|
| Burlington Medical, LLC | UDI-DI | 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 1,129 units |
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.