# Innolatex Sdn. Bhd

- Location (FDA's records): Shah Alam,Selangor Darul Ehsan, MY
- FDA decisions: 9 (2000–2006): 9 510(k) clearances
- Product codes: HIS (8), LTZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thai Nippon Rubber Industry Co., Ltd.: 1 (https://510kreport.com/company/thai-nippon-rubber-industry)
- Unidus Corp.: 1 (https://510kreport.com/company/unidus)

## Firms that cite its devices most
- Karex Industries Sdn. Bhd.: 4 (https://510kreport.com/company/karex-industries-sdn-bhd)
- Nrs Global Partners: 1 (https://510kreport.com/company/nrs-global-partners)
- Ssl Americas, Inc.: 1 (https://510kreport.com/company/ssl-americas)

## Its most-cited devices
- K012962: Dotted Condom, Male Natural Rubber Latex Condom (2001), cited by 2
- K053367: Male Natural Rubber Latex Condom (2006), cited by 1
- K002393: Non-Spermicidal Lubricated Male Latex Condom (2000), cited by 1
- K010919: Male Natural Rubber Latex Condom (2001), cited by 1
- K041837: Innolatex Male Latex Condoms Colored and Scented (2004), cited by 1

## Recent decisions
- K053367: Male Natural Rubber Latex Condom (Feb 21, 2006)
- K041837: Innolatex Male Latex Condoms Colored and Scented (Sep 24, 2004)
- K012964: 56MM Condom,Male Natural Rubber Latex Condom (Nov 9, 2001)
- K012962: Dotted Condom, Male Natural Rubber Latex Condom (Nov 9, 2001)
- K012665: Ultra Thin Male Latex Condom with Silicone Lubricant (Nov 9, 2001)
- K012664: Ultra Thick Male Latex Condom with Silicone Lubricant (Nov 9, 2001)
- K010919: Male Natural Rubber Latex Condom (Jun 15, 2001)
- K010178: Spermicidal Lubricated Male Latex Condom (Apr 27, 2001)

Source page: https://510kreport.com/company/innolatex-sdn-bhd