Reference Source

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

For Changzhou UNIVERSAL MEDICAL EQUIPMENT 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 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 2026-09-30.

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

— 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: 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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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