F17
Custom F17: Frontal Apron with Stretch Velcro Closure .35mm Regular Lead Size Three Extra Large Female
6manufacturers in China registered for this device type
345catalogue 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 | 2020-12-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECSBF17F | Female Large | In distribution |
| RLF17G | Female Large Plus | In distribution |
| ECSLF17XLF | Female XL | In distribution |
| SLF17XSM | XS Male | In distribution |
| SLF17F | Female Large | In distribution |
| ECRBF17E | Female Medium | In distribution |
| ULF17-XSF | In distribution | |
| RLF17E | Female Medium | In distribution |
| UBF17-3XM | XS Female | In distribution |
| STLF17-XSM | In distribution | |
| RTLF17-3XF | In distribution | |
| SBF17*F | Tailored | In distribution |
| SLF17-SM | In distribution | |
| SCCF17-LF | In distribution | |
| SBF17-3XM | XS Female | In distribution |
| SLF17G | Female Large Plus | In distribution |
| ULF17-XXSF | In distribution | |
| RPRF17-PF | In distribution | |
| RBF17XXLM | 2XL Male | In distribution |
| SBF17-MF | In distribution | |
| RCCF17-PF | In distribution | |
| SLF17-LM | In distribution | |
| UBF17-2XF | XS Female | In distribution |
| SCCF17-3XF | In distribution | |
| SLF173XLF | Female Large | In distribution |
| SLF17B | Male Medium | In distribution |
| SLF17-3XF | In distribution | |
| ECRLF17XLM | Male XL | In distribution |
| RTLF17-XSM | In distribution | |
| RTLF17-XSF | In distribution | |
| ULF17F | Female Large | In distribution |
| RPRF17-XLF | In distribution | |
| STLF17-XXF | In distribution | |
| RTLF17-MM | In distribution | |
| RBF17B | Male Medium | In distribution |
| RBF17XSM | XS Male | In distribution |
| RCCF17-3XF | In distribution | |
| UBF173XLF | 3XL Female | In distribution |
| RCCF17-5XM | In distribution | |
| ULF17D | Female Small | In distribution |
| ULF17-XLF | In distribution | |
| ULF17-XLM | In distribution | |
| UBF17C | Male Large | In distribution |
| ECRLF17E | In distribution | |
| RLF17*M | Tailored | In distribution |
| STLF17-SM | In distribution | |
| RLF17XSF | XS Female | In distribution |
| SBF17-LM | In distribution | |
| SBF17-LF | In distribution | |
| ULF173XLF | 3XL Female | In distribution |
| RBF17-PLUS | In distribution | |
| RBF17-LF | In distribution | |
| ULF17A | Male Small | In distribution |
| RLF17-XSF | In distribution | |
| RBF17-MF | In distribution | |
| SLF174XLF | 4XL Female | In distribution |
| SLF17C | Male Large | In distribution |
| SLF17-2XM | In distribution | |
| RLF17XXLM | 2XL Male | In distribution |
| ECSBF17XLM | Male XL | In distribution |
| RPRF17-LF | In distribution | |
| SBF17D | Female Small | In distribution |
| RLF174XLM | 4XL Male | In distribution |
| ULF17XLF | Female XL | In distribution |
| ECSLF17B | Male Medium | In distribution |
| UBF17-SM | In distribution | |
| RLF17D | Female Small | In distribution |
| RCCF17-XSM | In distribution | |
| UBF17-PLUS | In distribution | |
| SLF17-XXSF | In distribution | |
| RCCF17-XLF | In distribution | |
| RBF17*F | Tailored | In distribution |
| RTLF17-XLM | In distribution | |
| RPRF17-LM | In distribution | |
| UBF17*M | Tailored | In distribution |
| SBF175XLM | 5XL Male | In distribution |
| ECRLF17B | Male Medium | In distribution |
| ULF173XLM | 3XL Male | In distribution |
| STLF17-XLF | In distribution | |
| SLF175XLM | 5XL Male | In distribution |
| STLF17-3XF | In distribution | |
| ULF17-3XM | In distribution | |
| RLF17-XLM | In distribution | |
| ULF17-PLUS | In distribution | |
| SBF17G | Female Large Plus | In distribution |
| ULF17C | Male Large | In distribution |
| RCCF17-SF | In distribution | |
| UBF17XXLM | 2XL Male | In distribution |
| SCCF17-XXM | In distribution | |
| RBF17G | Female Large Plus | In distribution |
| ULF175XLM | 5XL Male | In distribution |
| RTLF17-SF | In distribution | |
| SCCF17-XSM | In distribution | |
| SBF17XLF | Female XL | In distribution |
| SBF17XXLM | 2XL Male | In distribution |
| ECSLF17A | Male Small | In distribution |
| ULF17-2XF | In distribution | |
| RLF17C | Male Large | In distribution |
| UBF17XSM | XS Male | In distribution |
| RPRF17-SF | In distribution | |
| RCCF17-XSF | In distribution | |
| ULF17-SM | In distribution | |
| UBF17-2XM | XS Female | In distribution |
| SBF17-3XF | XS Female | In distribution |
| RBF17XSF | XS Female | In distribution |
| RTLF17-4XF | In distribution | |
| SCCF17-LM | In distribution | |
| ULF17-MF | In distribution | |
| RLF17-SM | In distribution | |
| SCCF17-3XM | In distribution | |
| SLF17E | Female Medium | In distribution |
| SLF17XSF | XS Female | In distribution |
| ECRBF17XLM | Male XL | In distribution |
| SLF17-LF | In distribution | |
| ULF17XSF | XS Female | In distribution |
| STLF17-5XM | In distribution | |
| RTLF17-SM | In distribution | |
| ULF17XSM | XS Male | In distribution |
| SCCF17-XSF | In distribution | |
| SLF17XSM | XS Male | In distribution |
| ULF17-LF | In distribution | |
| UBF17G | Female Large Plus | In distribution |
| SBF17XXLF | 2XL Female | In distribution |
| STLF17-4XM | In distribution | |
| ECRLF17D | Female Small | In distribution |
| RLF173XLM | 3XL Male | In distribution |
| RLF17-LM | In distribution | |
| ECRBF17B | Male Medium | In distribution |
| RBF17D | Female Small | In distribution |
| RBF17A | Male Small | In distribution |
| RLF17B | Male Medium | In distribution |
| RBF17XXLF | 2XL Female | In distribution |
| UBF17XSF | XS Female | In distribution |
| RLF17-LF | In distribution | |
| RLF17*F | Tailored | In distribution |
| RBF17XLM | Male XL | In distribution |
| SLF17XXLF | 2XL Female | In distribution |
| UBF17XLM | Male XL | In distribution |
| SLF17XLF | Female XL | In distribution |
| ECSLF17F | Female Large | In distribution |
| RLF175XLM | 5XL Male | In distribution |
| ULF17XSM | XS Male | In distribution |
| RBF174XLM | 4XL Male | In distribution |
| RLF17XSM | XS Male | In distribution |
| UBF173XLM | 3XL Male | In distribution |
| UBF17-MM | In distribution | |
| RCCF17-LF | In distribution | |
| SBF17C | Male Large | In distribution |
| STLF17-3XM | In distribution | |
| RTLF17-MF | In distribution | |
| RBF17F | Female Large | In distribution |
| UBF17-3XF | XS Female | In distribution |
| SCCF17-MM | In distribution | |
| ECSBF17B | Male Medium | In distribution |
| ULF175XLF | 5XL Female | In distribution |
| UBF17E | Female Medium | In distribution |
| UBF175XLM | 5XL Male | In distribution |
| SLF17-PLUS | In distribution | |
| ULF174XLF | 4XL Female | In distribution |
| SLF17*F | Tailored | In distribution |
| RCCF17-5XF | In distribution | |
| UBF17-LF | In distribution | |
| RLF17F | Female Large | In distribution |
| RPRF17-XLM | In distribution | |
| SLF17XSF | XS Female | In distribution |
| ULF17*F | Tailored | In distribution |
| SBF173XLM | 3XL Male | In distribution |
| SBF17F | Female Large | In distribution |
| SLF17XXLM | 2XL Male | In distribution |
| RPRF17-4XF | In distribution | |
| RBF17*M | Tailored | In distribution |
| SCCF17-XXF | In distribution | |
| SBF17XSF | XS Female | In distribution |
| RPRF17-MF | In distribution | |
| RCCF17-XLM | In distribution | |
| ULF17XLM | Male XL | In distribution |
| RBF17-MM | In distribution | |
| RCCF17-SM | In distribution | |
| SBF17-SM | In distribution | |
| ECRBF17F | Female Large | In distribution |
| RBF17XSF | XS Female | In distribution |
| RTLF17-XXF | In distribution | |
| SCCF17-4XF | In distribution | |
| RLF17-2XF | In distribution | |
| ECRBF17A | Male Small | In distribution |
| RCCF17-XXM | In distribution | |
| SBF17XSF | XS Female | In distribution |
| UBF17XXLF | 2XL Female | In distribution |
| RTLF17-5XF | In distribution | |
| RCCF17-MF | In distribution | |
| SBF17*M | Tailored | In distribution |
| ECSLF17E | Female Medium | In distribution |
| ECRLF17C | Male Large | In distribution |
| UBF17A | Male Small | In distribution |
| UBF17XSM | XS Male | In distribution |
| SBF17XSM | XS Male | In distribution |
| SBF17-2XF | XS Female | In distribution |
| ULF17-LM | In distribution | |
| ULF17E | Female Medium | In distribution |
| SLF17*M | Tailored | In distribution |
| SLF17-3XM | In distribution | |
| RPRF17-SM | In distribution | |
| ECRBF17C | Male Large | In distribution |
| RCCF17-XXF | In distribution | |
| SLF17-XSM | In distribution | |
| SCCF17-5XF | In distribution | |
| SCCF17-MF | In distribution | |
| ULF17-3XF | In distribution | |
| STLF17-LM | In distribution | |
| SLF17-SF | In distribution | |
| RLF17A | Male Small | In distribution |
| UBF17-XXSF | In distribution | |
| SBF17A | Male Small | In distribution |
| SBF17E | Female Medium | In distribution |
| SLF17-XSF | In distribution | |
| SLF175XLF | 5XL Female | In distribution |
| SLF17-MM | In distribution | |
| STLF17-MM | In distribution | |
| SCCF17-4XM | In distribution | |
| SBF174XLF | 4XL Female | In distribution |
| STLF17-MF | In distribution | |
| UBF17-LM | In distribution | |
| RLF174XLF | 4XL Female | In distribution |
| UBF17F | Female Large | In distribution |
| ULF17-2XM | In distribution | |
| UBF17XSF | XS Female | In distribution |
| RLF17-2XM | In distribution | |
| SLF17-XLF | In distribution | |
| RTLF17-LM | In distribution | |
| STLF17-XSF | In distribution | |
| RBF173XLM | 3XL Male | In distribution |
| SLF173XLM | 3XL Male | In distribution |
| UBF17-SF | In distribution | |
| ECRBF17D | Female Small | In distribution |
| UBF175XLF | 5XL Female | In distribution |
| SLF17-MF | In distribution | |
| UBF174XLM | 4XL Male | In distribution |
| UBF17B | Male Medium | In distribution |
| STLF17-SF | In distribution | |
| ECSLF17D | Female Small | In distribution |
| RBF17-XXSF | In distribution | |
| STLF17-PF | In distribution | |
| RLF17-XSM | In distribution | |
| RLF17-3XF | In distribution | |
| SLF17-XLM | In distribution | |
| RBF174XLF | 4XL Female | In distribution |
| RPRF17-MM | In distribution | |
| ULF17XSF | In distribution | |
| RLF17-MM | In distribution | |
| RTLF17-4XM | 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 |
| 601 | Burlington Medical, LLC | 352 |
| 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.