# Zhangjiagang Jiamei Rubber Product Co. Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhangjiagang Jiamei Rubber Product 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 Black Lightning Powder Free Nitrile Examination Gloves pH 5.5 (sizes M L XL XXL) | Megaman Powder-Free Black Nitrile Flock-Lined Examination Gloves (size XXL); product code is 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly; date published is 10/09/2015; address is No. 85 Shuanglong Road , Fenghuangzhen Zhangjiagang , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhangjiagang Jiamei Rubber Product 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. 85 Shuanglong Road , Fenghuangzhen Zhangjiagang , Suzhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 10/09/2015 _(verified: appears in the quote below)_
- **Product code:** 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly _(verified: each item appears in the quote below)_
- **Product:** Black Lightning Powder Free Nitrile Examination Gloves pH 5.5 (sizes M L XL XXL) | Megaman Powder-Free Black Nitrile Flock-Lined Examination Gloves (size XXL) _(verified: each item appears in the quote below)_
- **FDA notes:** Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. | Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. Only size XXL is subject to the alert. _(verified: each item appears in the quote below)_

## What the source says

> Zhangjiagang Jiamei Rubber Product Co. Ltd Date Published : 10/09/2015 No. 85 Shuanglong Road , Fenghuangzhen Zhangjiagang , Suzhou, Jiangsu CHINA 80 L - - ZA Glove, Patient Examination, Poly Date Published: 02/05/2020 Desc: Black Lightning Powder Free Nitrile Examination Gloves pH 5.5 (sizes M L XL XXL) Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. 80 L - - ZA Glove, Patient Examination, Poly Date Published: 02/05/2020 Desc: Megaman Powder-Free Black Nitrile Flock-Lined Examination Gloves (size XXL) Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. Only size XXL is subject to the alert.

## 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/).