# Burnet Laboratoire Pharmaceutique · 89-08 · FRANCE — FDA import alert red lists: firms subject to detention without physical examination

For Burnet Laboratoire Pharmaceutique · 89-08 · FRANCE, 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 FRANCE; product is Sterile Surgical Gloves; product code is 80 K - - GO Surgeon's Gloves; date published is 09/16/2009; address is El Medico Chirurgical , 56 avenue de la Republique , La Ferte Bernard, Sarthe FRANCE, verified against its source on 2026-09-16.

- **Firm:** Burnet Laboratoire Pharmaceutique _(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:** FRANCE _(verified: appears in the quote below)_
- **Address:** El Medico Chirurgical , 56 avenue de la Republique , La Ferte Bernard, Sarthe FRANCE _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 80 K - - GO Surgeon's Gloves _(verified: appears in the quote below)_
- **Product:** Sterile Surgical Gloves _(verified: appears in the quote below)_

## What the source says

> Burnet Laboratoire Pharmaceutique Date Published : 09/16/2009 El Medico Chirurgical , 56 avenue de la Republique , La Ferte Bernard, Sarthe FRANCE 80 K - - GO Surgeon's Gloves Date Published: 11/08/2018 Desc: Sterile Surgical Gloves

## 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/).