Smart Glove Corporation Sdn Bhd
Malaysian manufacturer of cleanroom nitrile gloves, food grade nitrile gloves, sterile surgical
Smart Glove Corporation Sdn Bhd manufactures cleanroom nitrile gloves, food grade nitrile gloves, sterile surgical polyisoprene gloves, nitrile gloves, chloroprene & latex gloves, nitrile exa in Klang, Malaysia. The company was established in 1995 and supplies business customers in Malaysia and regional markets.
- Type
- Manufacturer
- Location
- Klang, Malaysia
- Founded
- 1995
- Website
- smartglove.com.my
- Categories
- Pantry & Dry Goods, Medical & Healthcare Supplies, Safety & Protective Equipment
- Markets
- Malaysia, Singapore
Verified facts
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- certificate-page-on-site (amber), checked 2026-08-12 Company's own certification page
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- places-goods-on-market (green), checked 2026-08-19 MDA MMDR (Malaysia Medical Device Register, Medical Device Authority), public search
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
Import rules for these goods
- EU imports of food of animal origin and many other food categories must be pre-notified in TRACES and enter through border control posts. European Commission (TRACES)
- US imports require the foreign facility to be FDA-registered and the importer to run a Foreign Supplier Verification Program (FSVP). US FDA
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)