# Letcom Medical Products Co.,Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Letcom Medical Products Co.,Ltd. · 89-08 · CHINA, 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 CHINA; product is Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove; product code is 80 F - - MC Glove, Patient Examination | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty; date published is 09/19/2023; address is No. 66 Zhen Dong Road , Dongli , Tianjin, Tianjin CHINA, verified against its source on 2026-09-16.

- **Firm:** Letcom Medical Products Co.,Ltd. _(verified: appears in the quote below)_
- **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:** CHINA _(verified: appears in the quote below)_
- **Address:** No. 66 Zhen Dong Road , Dongli , Tianjin, Tianjin CHINA _(verified: appears in the quote below)_
- **Date published:** 09/19/2023 _(verified: appears in the quote below)_
- **Product code:** 80 F - - MC Glove, Patient Examination | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty _(verified: each item appears in the quote below)_
- **Product:** Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove | Nitra Med HEAVY Powder Free Nitrile Examination Glove _(verified: each item appears in the quote below)_

## What the source says

> Letcom Medical Products Co.,Ltd. Date Published : 09/19/2023 No. 66 Zhen Dong Road , Dongli , Tianjin, Tianjin CHINA 80 F - - MC Glove, Patient Examination Date Published: 09/19/2023 Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove 80 L - - YY Glove, Patient Examination, Latex Date Published: 09/19/2023 Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove 80 L - - YZ Glove, Patient Examination, Vinyl Date Published: 09/19/2023 Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove 80 L - - ZA Glove, Patient Examination, Poly Date Published: 09/19/2023 Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 09/19/2023 Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).