Certificates & Quality Documentation
Explore HBM Protections’ certificates, regulatory documents and a Chinese invention patent supporting our surgical glove and condom business.
FDA 510(k) Clearance
FDA 510(k) clearance documentation is available for applicable surgical glove models intended for the U.S. market.
EU MDR certification documents are available for surgical gloves covered by the applicable certification scope.
ISO 13485 Certified
Our certified medical device quality management system supports controlled manufacturing and consistent product quality.
ISO 9001:2015
Our certified quality management system supports process control, continuous improvement and consistent customer service.
Free Sale Certificate
Export documentation issued by the Guangxi Medical Products Administration covers the medical products listed in the certificate.
ISO 14001:2015
Our certified environmental management system supports environmental controls across the operations covered by its scope.
FSC Chain of Custody Certification
Our FSC chain of custody certification supports traceability for forest-based materials within its certified scope.
Chinese Invention Patent
A Chinese invention patent for an antiviral medical latex product and its preparation method. Patent No. ZL 202110630002.9.
China Export Brand Certification
Medispo surgical and examination gloves hold China Export Brand certification issued by CCPIT.
Additional Product Documentation
Beyond the certificates shown above, further product documentation—including EN 455 test reports for applicable surgical gloves—is available on request. Contact our team for documents relevant to your products and destination market.
- ISO 13485 Certified
- CE / EU MDR Documentation
- FDA 510(k) Cleared
- EN 455 Tested
- FSC Chain of Custody Certified
Send Your Inquiry
Submit your sourcing requirements below. Our sales team will follow up by email.
- Discuss product options and pricing.
- Explore Medispo and Benow branded supply or private label manufacturing.
- Request documentation for your selected products and market.
