601
Tailored 601: Frontal Apron with Velcro Shoulder Closure (Quick Drop OR Apron) .5mm Regular Lead Size Three Extra Large Female
6manufacturers in China registered for this device type
352catalogue numbers in this listing
24recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Ekong Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Burlington Medical, LLC, United States |
|---|---|
| FDA product code | EAJ |
| Device type | Apron, Leaded |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-05 |
| Record revised | 2020-11-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-11-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCC601-XLM | In distribution | |
| RCC601-SF | In distribution | |
| RCC601-PF | In distribution | |
| RL601-3XM | In distribution | |
| UB601-3XF | Male XL | In distribution |
| SL601-XSF | In distribution | |
| UL601XSM | XS Male | In distribution |
| RCC601-3XF | In distribution | |
| UB6014XLF | 4XL Female | In distribution |
| UB601-2XF | Male XL | In distribution |
| UB601XXLF | 2XL Female | In distribution |
| UL601XLM | XL Male | In distribution |
| RB601-3XM | Male XL | In distribution |
| SB601-PLUS | In distribution | |
| UL601XXLM | 2XL Male | In distribution |
| STL601-XLM | In distribution | |
| SL601-LM | In distribution | |
| UL601F | Female Large | In distribution |
| RB601-MM | In distribution | |
| UB601XLF | XL Female | In distribution |
| RL601F | Female Large | In distribution |
| RL601*M | Tailored | In distribution |
| RCC601-MF | In distribution | |
| RL601-XLM | In distribution | |
| SCC601-5XF | In distribution | |
| RL601-MF | In distribution | |
| RB601*F | Medium Female | In distribution |
| RTL601-XLM | In distribution | |
| UL601-2XM | In distribution | |
| UB601-LM | In distribution | |
| SE601B | Male Medium | In distribution |
| UB601F | Female Large | In distribution |
| SCC601-SF | In distribution | |
| UL601G | Female Large Plus | In distribution |
| STL601-3XF | In distribution | |
| UB601-MF | In distribution | |
| RL6013XLF | 3XL Female | In distribution |
| SE6013XLF | 3XL Female | In distribution |
| SCC601-MF | In distribution | |
| SL601-LF | In distribution | |
| SB601-MF | In distribution | |
| SB601-3XF | Male XL | In distribution |
| RCC601-5XF | In distribution | |
| UL601-2XF | In distribution | |
| SB601-3XM | Male XL | In distribution |
| SL601XSM | XS Male | In distribution |
| SB601XLM | XL Male | In distribution |
| UB601D | Female Small | In distribution |
| SCC601-4XF | In distribution | |
| UL601-XSF | In distribution | |
| RL601*F | Tailored | In distribution |
| RB601-SM | In distribution | |
| RL601XSM | XS Male | In distribution |
| RB601-3XF | Male XL | In distribution |
| SB601XSF | XS Female | In distribution |
| RB601-XXSF | In distribution | |
| SL6014XLF | 4XL Female | In distribution |
| RL601-LM | In distribution | |
| UL601-PLUS | In distribution | |
| UB601XLM | XL Male | In distribution |
| RL601G | Female Large Plus | In distribution |
| SL601G | Female Large Plus | In distribution |
| UL601-3XM | In distribution | |
| UL601-SM | In distribution | |
| RL601-XLF | In distribution | |
| RB601G | Female Large Plus | In distribution |
| RCC601-5XM | In distribution | |
| SL601C | Male Large | In distribution |
| SB601-LF | In distribution | |
| SCC601-LF | In distribution | |
| RL601C | Male Large | In distribution |
| UL601-3XF | In distribution | |
| SB601-SM | In distribution | |
| UB6013XLF | 3XL Female | In distribution |
| RTL601-LM | In distribution | |
| UL6015XLM | 5XL Male | In distribution |
| RTL601-5XF | In distribution | |
| UL601-XLM | In distribution | |
| UB601A | Male Small | In distribution |
| SE6014XLF | 4XL Female | In distribution |
| SB601-2XF | Male XL | In distribution |
| RL601E | In distribution | |
| RB601*F | Tailored | In distribution |
| UL601C | Male Large | In distribution |
| SL6015XLF | 5XL Female | In distribution |
| UB601-PLUS | In distribution | |
| SCC601-LM | In distribution | |
| RCC601-MM | In distribution | |
| RL601-2XF | In distribution | |
| RTL601-XXF | In distribution | |
| RCC601-3XM | In distribution | |
| SL601-SM | In distribution | |
| SB601XXLF | 2XL Female | In distribution |
| SL601E | Female Medium | In distribution |
| SL601-2XM | In distribution | |
| RB601XLM | Male XL | In distribution |
| SL6013XLM | 3XL Male | In distribution |
| UL601*M | Tailored | In distribution |
| UB601C | Male Large | In distribution |
| RB601F | Female Large | In distribution |
| RL601D | Female Small | In distribution |
| RB601-2XM | Male XL | In distribution |
| RTL601-3XF | In distribution | |
| RL6013XLM | In distribution | |
| STL601-MF | In distribution | |
| RB6015XLM | 5XL Male | In distribution |
| SL601D | Female Small | In distribution |
| STL601-XXM | In distribution | |
| UB601-3XM | Male XL | In distribution |
| RTL601-XXM | In distribution | |
| UB601-LF | In distribution | |
| RTL601-XLF | In distribution | |
| RTL601-SM | In distribution | |
| UB601B | Male Medium | In distribution |
| RCC601-XLF | In distribution | |
| RL601XSF | XS Female | In distribution |
| STL601-XLF | In distribution | |
| RCC601-XSM | In distribution | |
| UB601-MM | In distribution | |
| SB601F | Female Large | In distribution |
| SE6013XLM | 3XL Male | In distribution |
| RB601*F | Small Female | In distribution |
| RTL601-PF | In distribution | |
| RCC601-4XM | In distribution | |
| RB601*F | Female Large Plus | In distribution |
| SCC601-XSM | In distribution | |
| UB601G | Female Large Plus | In distribution |
| SB601-MM | In distribution | |
| SCC601-3XF | In distribution | |
| RB601D | Female Small | In distribution |
| RB6015XLF | 5XL Female | In distribution |
| STL601-4XF | In distribution | |
| SL601XLF | XL Female | In distribution |
| UL601XSF | XS Female | In distribution |
| SB601E | Female Medium | In distribution |
| RB601XXLM | 2XL Male | In distribution |
| SCC601-MM | In distribution | |
| SL601-MM | In distribution | |
| RB601-PLUS | In distribution | |
| SB601*F | Female | In distribution |
| UB601*M | Tailored | In distribution |
| SB601-LM | In distribution | |
| RL601XXLM | 2XL Male | In distribution |
| RL601-2XM | In distribution | |
| RL6015XLF | 5XL Female | In distribution |
| STL601-XSF | In distribution | |
| SL601-XLF | In distribution | |
| RCC601-LM | In distribution | |
| RL6015XLM | 5XL Male | In distribution |
| SL601XSF | XS Female | In distribution |
| RB601*F | Large Female | In distribution |
| RB601-LF | In distribution | |
| UL601XXLF | 2XL Female | In distribution |
| RL601XLF | XL Female | In distribution |
| SCC601-4XM | In distribution | |
| UL601-XSM | In distribution | |
| SL601A | Male Small | In distribution |
| SL6015XLM | 5XL Male | In distribution |
| STL601-3XM | In distribution | |
| RB601-SF | In distribution | |
| UL601*F | Tailored | In distribution |
| SCC601-PF | In distribution | |
| UB601XXLM | 2XL Male | In distribution |
| SB601-2XM | Male XL | In distribution |
| STL601-SF | In distribution | |
| RB601*F | 4XL Female | In distribution |
| RB601XXLF | 2XL Female | In distribution |
| RL6014XLF | 4XL Female | In distribution |
| RTL601-4XM | In distribution | |
| RCC601-XXF | In distribution | |
| UB601E | Female Medium | In distribution |
| STL601-MM | In distribution | |
| RCC601-XLM | In distribution | |
| UL601-SF | In distribution | |
| SL601-PLUS | In distribution | |
| SB601C | Male Large | In distribution |
| RB601-LM | In distribution | |
| UL601-XLF | In distribution | |
| UL6015XLF | 5XL Female | In distribution |
| UB601XSM | XS Male | In distribution |
| SL6013XLF | 3XL Female | In distribution |
| UL601-MF | In distribution | |
| SCC601-XXM | In distribution | |
| RL601-XSM | In distribution | |
| RL601-LF | In distribution | |
| STL601-5XF | In distribution | |
| SL601B | Male Medium | In distribution |
| STL601-PF | In distribution | |
| SCC601-5XM | In distribution | |
| UB6013XLM | 3XL Male | In distribution |
| SCC601-XLF | In distribution | |
| RL6014XLM | 4XL Male | In distribution |
| RL601A | Male Small | In distribution |
| SCC601-3XM | In distribution | |
| SL601-3XF | In distribution | |
| RL601-MM | In distribution | |
| UB601-SM | In distribution | |
| RL601XXLF | 2XL Female | In distribution |
| RB601E | Female Medium | In distribution |
| STL601-LF | In distribution | |
| RTL601-MF | In distribution | |
| SE601*M | Tailored | In distribution |
| SB601XXLM | 2XL Male | In distribution |
| RCC601-SM | In distribution | |
| UBEURO4XLF | 4XL Female | In distribution |
| UL601-LF | In distribution | |
| RL601B | Male Medium | In distribution |
| UL601E | Female Medium | In distribution |
| UL601D | Female Small | In distribution |
| RB601-2XF | Male XL | In distribution |
| SL601-XSM | In distribution | |
| RTL601-XSF | In distribution | |
| RB601*F | 3XL Female | In distribution |
| RL601-XXSF | In distribution | |
| RTL601-XSM | In distribution | |
| SL601-XLM | In distribution | |
| RCC601-XSF | In distribution | |
| SB601-XXSF | In distribution | |
| SE6015XLM | 5XL Male | In distribution |
| RB6014XLM | 4XL Male | In distribution |
| UL601-MM | In distribution | |
| RL601-PLUS | In distribution | |
| SE601A | Male Small | In distribution |
| RL601-3XF | In distribution | |
| SL601XLM | XL Male | In distribution |
| UB601-SF | In distribution | |
| STL601-XSM | In distribution | |
| RTL601-LF | In distribution | |
| RB601A | In distribution | |
| UL601B | Male Medium | In distribution |
| UB601XSF | XS Female | In distribution |
| RL601XLM | XL Male | In distribution |
| RB601XSF | XS Female | In distribution |
| RB601XSM | XS Male | In distribution |
| SE601*F | Tailored | In distribution |
| RTL601-MM | In distribution | |
| SL601-3XM | In distribution | |
| UL6013XLF | 3XL Female | In distribution |
| RB601*F | 5XL Female | In distribution |
| UL6014XLF | 4XL Female | In distribution |
| UL6013XLM | 3XL Male | In distribution |
| RB601-MF | In distribution | |
| RL601-XSF | In distribution | |
| RB6013XLF | In distribution | |
| RL601-SF | In distribution | |
| UL601A | Male Small | In distribution |
| RTL601-SF | In distribution | |
| STL601-5XM | In distribution | |
| RB601B | Male Medium | In distribution |
| UB601-XXSF | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,161 |
| Wolf X-Ray | Flow X-Ray Corp. | 909 |
| ComfortLite | Aadco Medical, Inc. | 538 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 402 |
| Euro | Burlington Medical, LLC | 390 |
| Rayshield | Aadco Medical, Inc. | 380 |
| F17 | Burlington Medical, LLC | 345 |
| Techno-Aide | Techno-Aide, Inc. | 327 |
| F111 | Burlington Medical, LLC | 322 |
| Skirt | Burlington Medical, LLC | 312 |
| A10 | Burlington Medical, LLC | 286 |
| F112 | Burlington Medical, LLC | 283 |
Showing 12 of 118. All products under Apron, Leaded
Recalls
24 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 | Closed |
|---|---|---|---|---|---|
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 129 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 210 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 332 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 22 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 37 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 49 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 48 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 1 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2190 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 6 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 51 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 807 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 3 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 310 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 104 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 39 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
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.