Australia

Certifications

Certificates

Certifications

Gloveon’s quality standards, management systems and exemplary regulatory compliance, all contribute to the global success of the company. Our capabilities have been assessed and certified by the following international governing bodies.

iso-9001Management ServiceISO 9001:2008
ISO 13485:2003AmericaISO 13485:2003
EN ISO 13485:2003/AC:2009EN ISO 13485:2003/AC:2009
Confirmation Letter for GMP AuditJapanConfirmation Letter for GMP Audit
EC CertificateProduct ServiceEC Certificate
ISO 14001:2004ISO 14001:2004
UL CertificationUL Certification
ISEGA Food Contact Test Certification (German)ISEGA Food Contact Test
Certification (German)
Registration Certificate for Medical DeviceRegistration Certificate
for Medical Device
CGSB Certification of Medical Examinations Gloves program manualCGSB Certification
of Medical Examinations
Gloves program manual
510(k) Approval
PPE CertPPE Cert
ANVISA