Smart Glove Corporation Sdn Bhd

What is established and what is not

No researcher review has been written for this company yet. 3 official records from 3 official sources are on file. 3 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.

Facts on file, each with its evidence type

• No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-12. OpenSanctions
• Certificates named on their own site (record type: certificate-page-on-site; this record does not by itself establish manufacturing) [stated or published by the company, not an official record; status amber] Shows where the company itself claims the certificate, so you can open that page and judge it. checked 2026-08-12. Company's own certification page
• No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-12. OpenSanctions
• EAEU product declaration on record, company's role not established (record type: eaeu-product-declaration-party; this record does not by itself establish manufacturing) [official record; status green] An official EAEU register holds a declaration for specific goods that names this company; the record we hold does not say in which role (manufacturer, applicant or representative). It shows those products may be sold on the EAEU market, not a general quality mark. Paste the document number into the register search to see the record. checked 2026-08-16. EAEU unified register of certificates and declarations
• Places goods on the market (national producer register) (record type: places-goods-on-market; this record does not by itself establish manufacturing) [official record; status green] A state register lists this company as placing these goods on the market, as their maker or importer. By itself it does not show who makes them. checked 2026-08-19. MDA MMDR (Malaysia Medical Device Register, Medical Device Authority), public search
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 5 medical devices: Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K213373, 2022-03-10), PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs (K183280, 2019-07-26), Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs (K181047, 2019-01-09) +2. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)

Relationships

1 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.

Candidates, not confirmed

• smartglove.com.my: Website of this business. Source record

Import rules for these goods

• 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)
• Protective equipment (helmets, gloves, eyewear) sold in the EU falls under the PPE Regulation (EU) 2016/425 and needs CE marking. European Commission (PPE)

Goods family established: Fournitures médicales et de santé (official record of a specific product), Équipements de sécurité et de protection (the company's own text). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Épicerie sèche: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.

Check independently

• Sanctions and watchlists (OpenSanctions)