HEALTH CARE LATEX LTD. · 89-08 · INDIA
For HEALTH CARE LATEX LTD., import alert is 89-08; country is INDIA; 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)"; 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 2026-09-30.
- Firm
- HEALTH CARE LATEX 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
- INDIA verified
- Address
- A-33/A SECTOR-8 , Noida (U.P.), INDIA verified
- Date published
- 09/16/2009 verified
- Product code
- 78 H - - IR Perineometer | 85 H - - IS Condom | 85 L - - TZ Condom With Nonoxynol-9 | 85 M - - OL Condom, Non-Latex each item verified
- Product
- Latex Condoms verified
- FDA notes
- Latex Condoms 7/6/1992 | 5/16/2005 | Latex Condoms 7/6/1992 | Latex Condoms 7/6/1992 each item verified
What the source says
HEALTH CARE LATEX LTD. Date Published : 09/16/2009 A-33/A SECTOR-8 , Noida (U.P.), INDIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html