W114
Tailored: W114 One Piece Wrap Quick Release Side and Shoulder Closure .35mm Envirolite Xenolite 700-E, Size Tailored (TD) Female
46manufacturers in China registered for this device type
161catalogue numbers in this listing
13recalls on this code
Who Else Makes It
Concentrated in Zhejiang (9), Hubei (9), Jiangsu (8). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
Showing 12 of 46. All 46 manufacturers in China registered for Apron, Protective
Record
| Listed by | Burlington Medical, LLC, United States |
|---|---|
| FDA product code | IWO |
| Device type | Apron, Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R8W114-MM | In distribution | |
| U8W114-2XM | In distribution | |
| R3W114-MF | In distribution | |
| U8W114-3XM | In distribution | |
| R3W114*M | In distribution | |
| UEW114-PLUS | In distribution | |
| S8W114-3XF | In distribution | |
| U3W114*F | In distribution | |
| U8W114-SF | In distribution | |
| UEW114-XLM | In distribution | |
| SEW114*F | In distribution | |
| SEW114-SM | In distribution | |
| R3W114-SF | In distribution | |
| U3W114-XLM | In distribution | |
| UEW114*F | In distribution | |
| S8W114-XXSF | In distribution | |
| S3W114-2XM | In distribution | |
| U8W114-MM | In distribution | |
| U8W114-MF | In distribution | |
| S3W114-XSM | In distribution | |
| S3W114-PLUS | In distribution | |
| R8W114-3XM | In distribution | |
| R8W114-XLF | In distribution | |
| S8W114-MF | In distribution | |
| R3W114-LF | In distribution | |
| UEW114-XSF | In distribution | |
| S3W114-XSF | In distribution | |
| REW114*M | In distribution | |
| U8W114*F | In distribution | |
| SEW114-PLUS | In distribution | |
| U3W114-XLF | In distribution | |
| S8W114-SF | In distribution | |
| U3W114-LF | In distribution | |
| U3W114-LM | In distribution | |
| SEW114-LF | In distribution | |
| R8W114-XSF | In distribution | |
| U3W114-PLUS | In distribution | |
| REW114-XLM | In distribution | |
| REW114-3XF | In distribution | |
| U8W114*M | In distribution | |
| R3W114-2XF | In distribution | |
| R3W114-XXSF | In distribution | |
| S8W114-XLF | In distribution | |
| UEW114-SM | In distribution | |
| UEW114-XSM | In distribution | |
| R8W114-2XF | In distribution | |
| U8W114-LF | In distribution | |
| U8W114-XXSF | In distribution | |
| UEW114-LF | In distribution | |
| U3W114-XSF | In distribution | |
| R3W114-3XF | In distribution | |
| REW114-2XF | In distribution | |
| U8W114-PLUS | In distribution | |
| S8W114-SM | In distribution | |
| S3W114-LM | In distribution | |
| U3W114-2XM | In distribution | |
| S8W114-XLM | In distribution | |
| UEW114*M | In distribution | |
| S8W114*M | In distribution | |
| U8W114-2XF | In distribution | |
| REW114-3XM | In distribution | |
| R3W114-XSM | In distribution | |
| R8W114-SF | In distribution | |
| R8W114-SM | In distribution | |
| UEW114-LM | In distribution | |
| REW114-SM | In distribution | |
| REW114-LF | In distribution | |
| REW114-XSF | In distribution | |
| UEW114-2XM | In distribution | |
| SEW114-MF | In distribution | |
| S3W114-XLM | In distribution | |
| S8W114-XSM | In distribution | |
| R8W114-LM | In distribution | |
| S8W114-PLUS | In distribution | |
| S3W114*M | In distribution | |
| R3W114-3XM | In distribution | |
| S8W113-LF | In distribution | |
| R3W114-2XM | In distribution | |
| UEW114-MF | In distribution | |
| S5W114 | In distribution | |
| REW114-SF | In distribution | |
| SEW114-SF | In distribution | |
| S3W114-3XF | In distribution | |
| SEW114-MM | In distribution | |
| S3W114-LF | In distribution | |
| REW114-XSM | In distribution | |
| R8W114-3XF | In distribution | |
| S3W114-XXSF | In distribution | |
| SEW114-XLF | In distribution | |
| U3W114-3XF | In distribution | |
| R8W114-2XM | In distribution | |
| U3W114-XXSF | In distribution | |
| S8W114-XSF | In distribution | |
| UEW114-3XM | In distribution | |
| U3W114-3XM | In distribution | |
| REW114-PLUS | In distribution | |
| UEW114-XLF | In distribution | |
| U3W114-MF | In distribution | |
| SEW114-LM | In distribution | |
| U3W114*M | In distribution | |
| REW114*F | In distribution | |
| REW114-MF | In distribution | |
| SEW114-2XM | In distribution | |
| R3W114-XLM | In distribution | |
| R8W114*M | In distribution | |
| S3W114-2XF | In distribution | |
| SEW114-3XM | In distribution | |
| R3W114-LM | In distribution | |
| U8W114-XLM | In distribution | |
| S8W114-2XM | In distribution | |
| S8W114-MM | In distribution | |
| U8W114-XSM | In distribution | |
| U3W114-2XF | In distribution | |
| S8W114-LM | In distribution | |
| R8W114-MF | In distribution | |
| S3W114-XLF | In distribution | |
| U8W114-3XF | In distribution | |
| S8W114*F | In distribution | |
| R5W114 | In distribution | |
| SEW114-3XF | In distribution | |
| S8W114-LF | In distribution | |
| SEW114-2XF | In distribution | |
| R3W114-XLF | In distribution | |
| S3W114-SF | In distribution | |
| U3W114-SF | In distribution | |
| U8W114-SM | In distribution | |
| R8W114-XLM | In distribution | |
| SEW114-XSM | In distribution | |
| SEW114-XLM | In distribution | |
| R3W114-PLUS | In distribution | |
| S3W114-MM | In distribution | |
| UEW114-MM | In distribution | |
| S3W114-MF | In distribution | |
| R3W114-MM | In distribution | |
| S8W114-2XF | In distribution | |
| REW114-2XM | In distribution | |
| R8W114*F | In distribution | |
| U8W114-XLF | In distribution | |
| R3W114-SM | In distribution | |
| R8W114-XSM | In distribution | |
| REW114-MM | In distribution | |
| REW114-XLF | In distribution | |
| UEW114-SF | In distribution | |
| U5W114 | In distribution | |
| R3W114*F | In distribution | |
| S3W114*F | In distribution | |
| SEW114-XSF | In distribution | |
| R8W114-LF | In distribution | |
| R8W114-PLUS | In distribution | |
| S3W114-SM | In distribution | |
| U3W114-SM | In distribution | |
| UEW114-2XF | In distribution | |
| U8W114-XSF | In distribution | |
| UEW114-3XF | In distribution | |
| R8W114-XXSF | In distribution | |
| S8W114-3XM | In distribution | |
| SEW114*M | In distribution | |
| U8W114-LM | In distribution | |
| U3W114-MM | In distribution | |
| S3W114-3XM | In distribution | |
| U3W114-XSM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,932 |
| Wolf X-Ray | Flow X-Ray Corp. | 1,040 |
| Skirt | Burlington Medical, LLC | 678 |
| Euro | Burlington Medical, LLC | 407 |
| F111 | Burlington Medical, LLC | 385 |
| F112 | Burlington Medical, LLC | 348 |
| Pvest | Burlington Medical, LLC | 343 |
| Fvest | Burlington Medical, LLC | 342 |
| Vest | Burlington Medical, LLC | 337 |
| 601 | Burlington Medical, LLC | 330 |
| A10 | Burlington Medical, LLC | 329 |
| Thyroidshield | Burlington Medical, LLC | 311 |
Showing 12 of 236. All products under Apron, Protective
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. | 5,198 units |
Recalls
12 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 14323 |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 15,216 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 1,489 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 94 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 961 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 1,129 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 103 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 402 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 41,962 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 29 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 51 units |
| 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 15,438 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.