# Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** No. 6 Xinxi Road , Xinbei District , Changzhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 08/03/2022 _(verified: appears in the quote below)_
- **Product code:** 80 F - - MC Glove, Patient Examination | 80 L - - ZA Glove, Patient Examination, Poly _(verified: each item appears in the quote below)_
- **Product:** Nitrile Exam Gloves Powder Free Black | Nitrile Exam Gloves Powder Free Black _(verified: each item appears in the quote below)_

## 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

## Source

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

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).