A10
Custom A10: Frontal Apron with crisscross stretch back .35mm Regular Lead Size Three Extra Large Female
6manufacturers in China registered for this device type
286catalogue 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 | 2020-11-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RBA10F | Female Large | In distribution |
| SLA10-LM | In distribution | |
| RLA10C | Male Large | In distribution |
| ULA10-MM | In distribution | |
| RCCA10-XXM | In distribution | |
| RTLA10-XXF | In distribution | |
| RBA104XLM | 4XL Male | In distribution |
| RLA10-2XF | In distribution | |
| SCCA10-XLM | In distribution | |
| RBA10XXLF | In distribution | |
| RCCA10-LM | In distribution | |
| SBA10XXLF | 2XL Female | In distribution |
| SBA10E | Female Medium | In distribution |
| SLA103XLF | 3XL Female | In distribution |
| RBA103XLF | 3XL Female | In distribution |
| RTLA10-SF | In distribution | |
| SCCA10-3XF | In distribution | |
| SBA10-SM | In distribution | |
| RLA10F | Female Large | In distribution |
| SLA10XXLM | 2XL Male | In distribution |
| RTLA10-MM | In distribution | |
| SBA10F | Female Large | In distribution |
| ULA10-3XM | In distribution | |
| UBA10-MF | In distribution | |
| UBA10-3XM | Male XL | In distribution |
| SLA104XLF | 4XL Female | In distribution |
| ULA10E | Female Medium | In distribution |
| SLA10-3XM | In distribution | |
| RLA10-LM | In distribution | |
| UBA10-SM | In distribution | |
| RBA10XLF | Female XL | In distribution |
| SBA10C | Male Large | In distribution |
| SLA10E | Female Medium | In distribution |
| RBA10*F | Tailored | In distribution |
| SLA10*F | Tailored | In distribution |
| SLA10G | Female Large Plus | In distribution |
| RTLA10-4XM | In distribution | |
| RLA10-SF | In distribution | |
| STLA10-SM | In distribution | |
| SCCA10-MM | In distribution | |
| UBA10F | Female Large | In distribution |
| RBA10*M | Tailored | In distribution |
| SLA105XLF | 5XL Female | In distribution |
| SBA10B | Male Medium | In distribution |
| RBA10-SM | In distribution | |
| RLA103XLM | 3XL Male | In distribution |
| STLA10-XLM | In distribution | |
| RTLA10-MF | In distribution | |
| RTLA10-XLM | In distribution | |
| SBA103XLF | 3XL Female | In distribution |
| STLA10-5XM | In distribution | |
| ULA10XLF | Female XL | In distribution |
| SBA10XSF | XS Female | In distribution |
| UBA10D | Female Small | In distribution |
| RLA10XXLF | 2XL Female | In distribution |
| UBA10XXLF | 2XL Female | In distribution |
| SBA10-3XF | Male XL | In distribution |
| ULA10-2XM | In distribution | |
| RLA10-XSF | In distribution | |
| SCCA10-SM | In distribution | |
| STLA10-XSF | In distribution | |
| RBA10-XXSF | In distribution | |
| RTLA10-XXM | In distribution | |
| SBA10-PLUS | In distribution | |
| STLA10-MM | In distribution | |
| RBA103XLM | 3XL Male | In distribution |
| RBA10-MM | In distribution | |
| ULA10*F | Tailored | In distribution |
| RLA10*F | Tailored | In distribution |
| ULA10-LM | In distribution | |
| RLA105XLF | 5XL Female | In distribution |
| RBA10-LM | In distribution | |
| RTLA10-LM | In distribution | |
| SLA10A | Male Small | In distribution |
| SLA10-XSF | In distribution | |
| UBA10-3XF | Male XL | In distribution |
| ULA104XLF | 4XL Female | In distribution |
| RBA10B | Male Medium | In distribution |
| RLA10-XLM | In distribution | |
| RBA10-SF | In distribution | |
| SBA10XXLM | 2XL Male | In distribution |
| RCCA10-3XF | In distribution | |
| RBA10-2XM | Male XL | In distribution |
| RLA10G | Female Large Plus | In distribution |
| SLA10*M | Tailored | In distribution |
| RBA10-3XM | Male XL | In distribution |
| RCCA10-LF | In distribution | |
| SBA105XLM | 5XL Male | In distribution |
| RLA104XLM | 4XL Male | In distribution |
| ULA10-SF | In distribution | |
| RLA10XSM | XS Male | In distribution |
| SBA10XLM | Male XL | In distribution |
| SBA10-LF | In distribution | |
| RTLA10-3XM | In distribution | |
| RCCA10-5XM | In distribution | |
| ULA10*M | Tailored | In distribution |
| SCCA10-XLF | In distribution | |
| RLA10-SM | In distribution | |
| SCCA10-LM | In distribution | |
| SBA10*F | Tailored | In distribution |
| UBA10*M | Tailored | In distribution |
| SLA10XSM | XS Male | In distribution |
| SCCA10-4XM | In distribution | |
| SLA10-MM | In distribution | |
| RTLA10-PF | In distribution | |
| SBA10-SF | In distribution | |
| ULA10-SM | In distribution | |
| ULA10C | Male Large | In distribution |
| SBA10XSM | XS Male | In distribution |
| SBA10-MM | In distribution | |
| RTLA10-5XF | In distribution | |
| SCCA10-XSF | In distribution | |
| RLA10-2XM | In distribution | |
| STLA10-XXF | In distribution | |
| ULA10F | Female Large | In distribution |
| UBA105XLF | 5XL Female | In distribution |
| RCCA10-XLF | In distribution | |
| UBA10-MM | In distribution | |
| ULA10A | Male Small | In distribution |
| ULA105XLM | 5Xl Male | In distribution |
| UBA10B | Male Medium | In distribution |
| RTLA10-5XM | In distribution | |
| UBA10XSF | XS Female | In distribution |
| SCCA10-LF | In distribution | |
| RTLA10-XSM | In distribution | |
| SLA10-MF | In distribution | |
| RBA10-PLUS | In distribution | |
| SCCA10-XSM | In distribution | |
| RLA10D | Female Small | In distribution |
| RLA105XLM | 5XL Male | In distribution |
| ULA10G | Female Large Plus | In distribution |
| RBA105XLM | 5XL Male | In distribution |
| SCCA10-3XM | In distribution | |
| RBA10XSM | XS Male | In distribution |
| RCCA10-XXF | In distribution | |
| SLA10C | Male Large | In distribution |
| RLA10*M | Tailored | In distribution |
| ULA10-XSF | In distribution | |
| SLA10F | Female Large | In distribution |
| RLA10-PLUS | In distribution | |
| ULA10D | Female Small | In distribution |
| SCCA10-4XF | In distribution | |
| RLA103XLF | 3XL Female | In distribution |
| UBA10XLF | Female XL | In distribution |
| ULA10-XSM | In distribution | |
| RBA10XSF | XS Female | In distribution |
| SLA10-PLUS | In distribution | |
| STLA10-XLF | In distribution | |
| SLA10-SM | In distribution | |
| ULA10-XLF | In distribution | |
| RCCA10-XSM | In distribution | |
| RBA10G | Female Large Plus | In distribution |
| ULA103XLF | 3XL Female | In distribution |
| SLA10XLF | Female XL | In distribution |
| UBA10-2XM | Male XL | In distribution |
| SCCA10-5XF | In distribution | |
| SBA10*M | Tailored | In distribution |
| SBA10-2XM | Male XL | In distribution |
| ULA10B | Male Medium | In distribution |
| RBA10XXLM | 2XL Male | In distribution |
| UBA104XLM | 4XL Male | In distribution |
| STLA10-LM | In distribution | |
| RTLA10-3XF | In distribution | |
| STLA10-3XM | In distribution | |
| STLA10-PF | In distribution | |
| UBA10XXLM | 2XL Male | In distribution |
| UBA10*F | Tailored | In distribution |
| STLA10-3XF | In distribution | |
| UBA10-LF | In distribution | |
| RCCA10-4XM | In distribution | |
| SCCA10-XXM | In distribution | |
| ULA10XSM | XS Male | In distribution |
| RCCA10-3XM | In distribution | |
| SLA10-XLF | In distribution | |
| SBA104XLM | 4XL Male | In distribution |
| RTLA10-XSF | In distribution | |
| UBA10C | Male Large | In distribution |
| ULA10-MF | In distribution | |
| SLA10-XSM | In distribution | |
| ULA10-2XF | In distribution | |
| UBA10-XXSF | In distribution | |
| RCCA10-XSF | In distribution | |
| STLA10-SF | In distribution | |
| RLA10-XSM | In distribution | |
| ULA104XLM | 4XL Male | In distribution |
| RLA10-MF | In distribution | |
| SBA10XLF | Female XL | In distribution |
| SBA10D | Female Small | In distribution |
| UBA10E | Female Medium | In distribution |
| SCCA10-PF | In distribution | |
| SLA10-XXSF | In distribution | |
| RBA105XLF | 5XL Female | In distribution |
| UBA10XSM | XS Male | In distribution |
| RBA10E | Female Medium | In distribution |
| SBA103XLM | 3XL Male | In distribution |
| SCCA10-MF | In distribution | |
| ULA10-LF | In distribution | |
| STLA10-LF | In distribution | |
| RLA10XLM | Male XL | In distribution |
| ULA10XXLM | 2XL Male | In distribution |
| SCCA10-SF | In distribution | |
| SBA105XLF | 5XL Female | In distribution |
| STLA10-XXM | In distribution | |
| SBA10-2XF | Male XL | In distribution |
| RLA10-XXSF | In distribution | |
| RLA10-XLF | In distribution | |
| UBA103XLF | 3XL Female | In distribution |
| SLA10-2XF | In distribution | |
| RLA10-LF | In distribution | |
| UBA10A | Male Small | In distribution |
| ULA10-PLUS | In distribution | |
| ULA10XXLF | 2XL Female | In distribution |
| STLA10-4XF | In distribution | |
| SBA10-3XM | Male XL | In distribution |
| SBA10A | Male Small | In distribution |
| RLA10XLF | Female XL | In distribution |
| ULA103XLM | 3XL Male | In distribution |
| ULA105XLF | 5XL Female | In distribution |
| SLA10XSF | XS Female | In distribution |
| SCCA10-XXF | In distribution | |
| RBA10-2XF | Male XL | In distribution |
| UBA10-2XF | Male XL | In distribution |
| STLA10-4XM | In distribution | |
| SLA10-3XF | In distribution | |
| ULA10XSF | XS Female | In distribution |
| SLA10XLM | Male XL | In distribution |
| RTLA10-LF | In distribution | |
| RBA10D | Female Small | In distribution |
| RTLA10-4XF | In distribution | |
| UBA105XLM | 5XL Male | In distribution |
| SLA10-2XM | In distribution | |
| RBA10-MF | In distribution | |
| RLA10XSF | XS Female | In distribution |
| SLA10-LF | In distribution | |
| RCCA10-5XF | In distribution | |
| RCCA10-MF | In distribution | |
| SLA10D | Female Small | In distribution |
| RBA10C | Male Large | In distribution |
| UBA10XLM | Male XL | In distribution |
| SLA105XLM | 5XL Male | In distribution |
| UBA104XLF | 4XL Female | In distribution |
| ULA10-XLM | In distribution | |
| RCCA10-PF | In distribution | |
| ULA10-3XF | In distribution | |
| ULA10XLM | Male XL | In distribution |
| RLA10A | Male Small | In distribution |
| RCCA10-SM | In distribution | |
| RLA10-3XM | In distribution | |
| SBA10-MF | In distribution | |
| RLA104XLF | 4XL Female | In distribution |
Showing 250 of 286 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 |
| 601 | Burlington Medical, LLC | 352 |
| F17 | Burlington Medical, LLC | 345 |
| Techno-Aide | Techno-Aide, Inc. | 327 |
| F111 | Burlington Medical, LLC | 322 |
| Skirt | Burlington Medical, LLC | 312 |
| 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.