Zhangjiagang Jiamei Rubber Product Co. Ltd · 89-08 · CHINA
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
- 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. 85 Shuanglong Road , Fenghuangzhen Zhangjiagang , Suzhou, Jiangsu CHINA verified
- Date published
- 10/09/2015 verified
- Product code
- 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly each item verified
- 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) each item verified
- 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. each item verified
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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html