Nathan Trading Co., Ltd. · 89-08 · THAILAND
For Nathan Trading Co., Ltd., import alert is 89-08; country is THAILAND; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html