# Fuji Latex Co., Ltd. · 89-08 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For Fuji Latex Co., Ltd. · 89-08 · JAPAN, 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 JAPAN; product code is 85 H - - IS Condom; date published is 09/16/2009; address is 150 Ko-Machi , Tokyo, JAPAN, verified against its source on 2026-09-16.

- **Firm:** Fuji Latex 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:** JAPAN _(verified: appears in the quote below)_
- **Address:** 150 Ko-Machi , Tokyo, JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 85 H - - IS Condom _(verified: appears in the quote below)_
- **FDA notes:** Wrinkle Chapeau Condoms. 7/20/1993 _(verified: appears in the quote below)_

## What the source says

> Fuji Latex Co., Ltd. Date Published : 09/16/2009 150 Ko-Machi , Tokyo, JAPAN 85 H - - IS Condom Date Published: 09/16/2009 Notes: Wrinkle Chapeau Condoms. 7/20/1993

## 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/).