MDR-compliant disposable footwear for chemical and biological splash protection

Key Features

Reliable Liquid Barrier: Monolithic polyethylene construction provides certified liquid splash protection (EN 13832-3 Type 6)

Medical-Grade Safety: MDR Class I medical device certification ensures compliance for healthcare and laboratory use

Static Control Protection: Static dissipative properties (<10⁹Ω) prevent charge accumulation in sensitive environments

Contamination Control: Low-lint design (<0.5mg/m³) maintains cleanroom integrity and reduces particulate contamination

Technical Specifications

Material: 100% polyethylene (0.8mm thickness)
Color: Standard blue (RAL 5015)
Protection: EN 13832-3 Type 6, bloodborne pathogen resistance (ISO 16604)
Electrical: Static dissipative (<10⁹Ω per EN 61340-5-1)
Cleanroom: Low-lint (<0.5mg/m³ per IEST-RP-CC003.6)
Certifications: MDR (EU) 2017/745 Class I, EN ISO 13485:2016, EN ISO 10993-5
Packaging: 100 boots/pack (50 pairs), 1,000 boots/case (500 pairs), 10,000 boots/pallet (5,000 pairs)

Application Deployment

Healthcare Facilities: Isolation rooms, operating theaters, and sterile processing areas requiring bloodborne pathogen protection

Laboratory Environments: Chemical handling, biological research, and diagnostic labs with splash hazards

Pharmaceutical Production: Cleanroom manufacturing and compounding areas needing static control and low-lint properties

Emergency Decontamination: Chemical spill response and biological hazard situations requiring immediate disposable protection