Careplus Sdn. Bhd., the Malaysia-based parent of CAREGLOVE, has made disposable gloves since 1991 and is publicly traded on Bursa Malaysia. With more than 30 years of manufacturing experience, it produces billions of gloves annually in FDA-registered, ISO-certified facilities and supplies U.S. customers through its Careglove USA operation.
FDA 510(k) Approval
FDA-Registered Manufacturing Facilities
Registration
ISO 9001:2015 Quality Management Systems
ISO 13485:2016 Medical Device – Quality Management Systems
ISO 14001:2015 Environmental Management Systems
CE Marking
EC Certificate for Class IIa according to MDD 93/42/EEC
National Fire Protection Association (NFPA)
NFPA 1999 UL Certification
National Medical Products Administration (NMPA)
PPE Notified Body
Brazil National Health Surveillance Agency
FDA
Quality certification
CE
Quality certification
ECCERTIFICATECLASSIIA
Quality certification
UL
Quality certification
ANVISA
Quality certification