Reference Source

Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD · 89-08 · CHINA

For Changzhou UNIVERSAL MEDICAL EQUIPMENT 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 Nitrile Exam Gloves Powder Free Black | Nitrile Exam Gloves Powder Free Black; product code is 80 F - - MC Glove, Patient Examination | 80 L - - ZA Glove, Patient Examination, Poly; date published is 08/03/2022; address is No. 6 Xinxi Road , Xinbei District , Changzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm
Changzhou UNIVERSAL MEDICAL EQUIPMENT 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. 6 Xinxi Road , Xinbei District , Changzhou, Jiangsu CHINA verified
Date published
08/03/2022 verified
Product code
80 F - - MC Glove, Patient Examination | 80 L - - ZA Glove, Patient Examination, Poly each item verified
Product
Nitrile Exam Gloves Powder Free Black | Nitrile Exam Gloves Powder Free Black 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

Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD Date Published : 08/03/2022 No. 6 Xinxi Road , Xinbei District , Changzhou, Jiangsu CHINA 80 F - - MC Glove, Patient Examination Date Published: 08/03/2022 Desc: Nitrile Exam Gloves Powder Free Black 80 L - - ZA Glove, Patient Examination, Poly Date Published: 08/03/2022 Desc: Nitrile Exam Gloves Powder Free Black

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

Source

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