Reference Source

Letcom Medical Products Co.,Ltd. · 89-08 · CHINA

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

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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