# HEALTH CARE LATEX LTD. · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For HEALTH CARE LATEX LTD. · 89-08 · INDIA, 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 INDIA; product is Latex Condoms; product code is 78 H - - IR Perineometer | 85 H - - IS Condom | 85 L - - TZ Condom With Nonoxynol-9 | 85 M - - OL Condom, Non-Latex; date published is 09/16/2009; address is A-33/A SECTOR-8 , Noida (U.P.), INDIA, verified against its source on 2026-09-16.

- **Firm:** HEALTH CARE LATEX 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:** INDIA _(verified: appears in the quote below)_
- **Address:** A-33/A SECTOR-8 , Noida (U.P.), INDIA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 78 H - - IR Perineometer | 85 H - - IS Condom | 85 L - - TZ Condom With Nonoxynol-9 | 85 M - - OL Condom, Non-Latex _(verified: each item appears in the quote below)_
- **Product:** Latex Condoms _(verified: appears in the quote below)_
- **FDA notes:** Latex Condoms 7/6/1992 | 5/16/2005 | Latex Condoms 7/6/1992 | Latex Condoms 7/6/1992 _(verified: each item appears in the quote below)_

## What the source says

> HEALTH CARE LATEX LTD. Date Published : 09/16/2009 A-33/A SECTOR-8 , Noida (U.P.), INDIA 78 H - - IR Perineometer Date Published: 11/08/2018 Notes: Latex Condoms 7/6/1992 85 H - - IS Condom Date Published: 01/23/2019 Desc: Latex Condoms Notes: 5/16/2005 85 L - - TZ Condom With Nonoxynol-9 Date Published: 09/16/2009 Notes: Latex Condoms 7/6/1992 85 M - - OL Condom, Non-Latex Date Published: 09/16/2009 Notes: Latex Condoms 7/6/1992

## 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/).