In May 2022, Guilin HBM Health Protections, Inc. obtained EU Medical Device Regulation (MDR) certification from BSI (Notified Body 2797) for its Medispo surgical glove product range. The certificate (MDR 747912 R000) confirms that HBM’s quality management system meets the requirements of Regulation (EU) 2017/745, Annex IX.
The current version of the certificate was issued on March 12, 2026, and is valid through May 11, 2027.
What Products Are Covered
The MDR certificate covers the following devices:
Device | Risk Class |
|---|---|
Powder-free natural rubber latex surgical gloves | Class IIa |
Powder-free synthetic polyisoprene (PI) surgical gloves | Class IIa |
Powder-free synthetic polychloroprene (neoprene) surgical gloves | Class IIa |
Natural rubber latex lubricated male condoms | Class IIb |
What MDR Certification Means for Buyers
The EU Medical Device Regulation (MDR, EU 2017/745) replaced the older Medical Devices Directive (MDD) in 2017 and imposed significantly higher requirements on manufacturers, including:
- Stronger clinical evaluation and performance evidence
- A more rigorous quality management system audit
- UDI (Unique Device Identification) requirements
- Ongoing post-market surveillance and vigilance reporting
- Design oversight for higher-risk devices
For distributors, importers and hospital procurement teams, an MDR certificate from a notified body such as BSI means the manufacturer has been audited against current EU standards — not just the older MDD regime that many manufacturers are still transitioning away from.
Certificate History
The HBM MDR certificate has been updated several times since first issuance:
- May 2022: Certificate first issued
- September 2023: Addition of the E-Beam sterilization subcontractor
- February 2024: Addition of natural rubber latex condoms to the scope
- October 2025: Change of EU Authorized Representative to Continental Medical B.V. (Rotterdam, Netherlands)
- March 2026: Addition of powder-free polychloroprene (neoprene) surgical gloves
HBM Protections and Medispo
HBM Protections manufactures surgical gloves and condoms under the Medispo and BENOW brands. The company operates 20 surgical glove production lines and 4 condom production lines, with products exported to more than 80 countries.
Request Certification Documents
If you are evaluating HBM Protections as a supplier, our team can provide:
- Copy of the MDR certificate (MDR 747912 R000)
- Declaration of Conformity
- Technical documentation summary
- FDA 510(k) clearance documents
- ISO 13485 certificate
Contact our team to request these documents or discuss OEM and private-label programs.
