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Wembley Rubber Products (M) Sdn Bhd

MalaysiaFDA applicant, unverified

Devices
61

What Wembley Rubber Products (M) Sdn Bhd makes

The company manufactures examination gloves, including powder-free nitrile, beaded hypoallergenic, and powdered nitrile varieties, as well as patient examination gloves and surgeon’s gloves. It also produces SCIPOTEX and PROFEEL gloves, along with Foley catheters.

These products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. The manufacturer is based in the US and has its products listed in the FDA’s 510(k) registry.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Wembley Rubber Products (M) Sdn Bhd have in the registry?

The registry currently lists 61 devices for Wembley Rubber Products (M) Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wembley Rubber Products (M) Sdn Bhd's devices?

Among its 50 most recently registered devices, Wembley Rubber Products (M) Sdn Bhd has devices listed in FDA 510(k) (50 devices).

What risk classes do Wembley Rubber Products (M) Sdn Bhd's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Wembley Rubber Products (M) Sdn Bhd's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Wembley Rubber Products (M) Sdn Bhd in the registry?

The most recently registered devices listed for Wembley Rubber Products (M) Sdn Bhd include SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES), SCIPOTEX, COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG) and COMFIT BLUE POWDER FREE EXAMINATION GLOVES.

Generated automatically from registry data and not verified by a human reviewer.