Reference Source

HEALTH CARE LATEX LTD. · 89-08 · INDIA

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.