Nathan Trading Co., Ltd. · 89-08 · THAILAND
For Nathan Trading Co., Ltd. · 89-08 · THAILAND, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is THAILAND; product is Nitrile Examination Glove | Nitrile Examination Glove | Nitrile Examination Glove | Nitrile Examination Glove; product code is 80 F - - MC Glove, Patient Examination | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty; date published is 01/12/2023; address is Moo 12 , 58 Palan Sub-District , Khemarat, Ubon Ratchathani THAILAND, verified against its source on 2026-09-16.
- Firm
- Nathan Trading Co., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- THAILAND verified
- Address
- Moo 12 , 58 Palan Sub-District , Khemarat, Ubon Ratchathani THAILAND verified
- Date published
- 01/12/2023 verified
- Product code
- 80 F - - MC Glove, Patient Examination | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty each item verified
- Product
- Nitrile Examination Glove | Nitrile Examination Glove | Nitrile Examination Glove | Nitrile Examination Glove each item verified
- FDA notes
- Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. | Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. | Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. | Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. each item verified
What the source says
Nathan Trading Co., Ltd. Date Published : 01/12/2023 Moo 12 , 58 Palan Sub-District , Khemarat, Ubon Ratchathani THAILAND 80 F - - MC Glove, Patient Examination Date Published: 01/12/2023 Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. 80 L - - YZ Glove, Patient Examination, Vinyl Date Published: 01/12/2023 Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. 80 L - - ZA Glove, Patient Examination, Poly Date Published: 01/12/2023 Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 01/12/2023 Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html