# Karex Industries Sdn. Bhd.

- Location (FDA's records): Pontian Kecil, Jalan Johor, MY
- FDA decisions: 8 (2007–2023): 8 510(k) clearances
- Product codes: HIS (6), NUC (2)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 3 (1 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
- Innolatex Sdn. Bhd: 4 (https://510kreport.com/company/innolatex-sdn-bhd)
- Dongkuk Techco Rubber Industries: 1 (https://510kreport.com/company/dongkuk-techco-rubber-industries)

## Firms that cite its devices most
- Theyfit: 2 (https://510kreport.com/company/theyfit)

## Its most-cited devices
- K070830: Male Natural Rubber Latex Condom (with Coloring and Flavoring) (2007), cited by 1
- K081886: Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated (2009), cited by 1
- K113061: Large/Extra Lagre Condom (2011), cited by 1

## Recent decisions
- K223519: Carex Hybrid Personal Lubricant (Aug 11, 2023)
- K150743: Water Based Personal Lubricant with Flavours (Nov 12, 2015)
- K141059: Natural Rubber Latex Male Condoms (Aug 1, 2014)
- K132597: Black Coloured Condom (Nov 25, 2013)
- K113056: Orange Colored Condoms Orange Scent (Jul 3, 2012)
- K113061: Large/Extra Lagre Condom (Dec 7, 2011)
- K081886: Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated (Feb 6, 2009)
- K070830: Male Natural Rubber Latex Condom (with Coloring and Flavoring) (May 8, 2007)

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