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