Description

Qualifications Summary:
 
SGS ISO14644-1 Class 7
SGS EN14683
SGS EN149 FFP3
 
Chinese National Standard (Tested by GTT Labs, CNAS)
GB 19083-2010 Medical protective
YY 0469-2010 Medical surgical
GB 2626-2006 Particle protective
 
Nelson Lab Reports
• Nelson N99 BFE & Delta P Test (ref: 1276505-S01)
• Nelson Flammability Test (ref: 1277395-S01)
• Nelson PFE99 Test (ref: 1276503-S01)
• Nelson Synthetic Blood Penetration Resistance Test (ref: 1276504-S01)
• Nelson VFE99 Test (ref:1276506-S01)
• Nelson Microbial Cleanliness (Bioburden) Test (ref:1276507-S01)
 
US FDA Registered
• Owner operator number:10062991
 
Australian Register of Therapeutic Goods (ARTG) inclusion
• ARTG Identifier: 336030
 
GMDN Registered
• 57794 (Surgical / Medical Respirator Single Use)
 
Certification：
FDA
ARTG
ISO 14644-1
SGS EN 13485
SGS EN 14683
SGS EN 149 FFP3
 

• Specialized in producing and refining professional medical devices
• Established to produce high quality medical masks， ranging from N95 respirator to daily surgical masks
• Visionary company with dedications to supply top quality
• personal protective equipment, medical devices and sterilization tools

 
With professional production, our factory have implemented intelligent management system and automated production tools connected with internet. We are committed to ensure every production processes are under transparent management and supervision, together with detailed quality inspection.
 
Besides strict internal control on product qualities, all our products have obtained relative certifications issued by respective national agencies and entrusted testing laboratories.
Quality inspections from renowned independent third parties will be conducted regularly.