Letcom Medical Products Co.,Ltd. · 89-08 · CHINA
For Letcom Medical Products Co.,Ltd., import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- Firm
- Letcom Medical Products 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
- CHINA verified
- Address
- No. 66 Zhen Dong Road , Dongli , Tianjin, Tianjin CHINA verified
- Date published
- 09/19/2023 verified
- 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 each item verified
- 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 each item verified
What the source says
Letcom Medical Products Co.,Ltd. Date Published : 09/19/2023 No. 66 Zhen Dong Road , Dongli , Tianjin, Tianjin CHINA
— 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 and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html