Medispec
Puchong surgical and examination glove producer certified to ISO 13485.
Medispec is a Malaysian medical glove manufacturer headquartered in Puchong, Selangor. The company produces surgical and examination gloves for medical professionals and exports to Europe, North America, and Australia under ISO 13485 quality management standards.
- Type
- Manufacturer
- Location
- Puchong, Malaysia
- Founded
- 2001
- Website
- medispec.com.my
- Categories
- Medical & Healthcare Supplies
- Markets
- United States, United Kingdom, Australia, Germany
Verified facts
- places-goods-on-market (green), checked 2026-08-19 MDA MMDR (Malaysia Medical Device Register, Medical Device Authority), public search
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
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)