Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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