Isolation Gown - Polypropylene with Polyethylene Coating 100pcs (IGPPE)
- Polypropylene with Polyethylene Coating (PPPE)
- Ultrasonic Welding
- Elastic Cuff or Knit Cuff
- Neck Tape and Waist Tie Closure
- Full Back Coverage
- FDA Registered Factory
- ISO Certified Factory
- For Level 1 and 2 Gowns - Class 1 Medical Device exempt from 510(k) Premarket
- For Level 3 Gown - Factory is processing their 510(k) Premarket Notification but the FDA has waived this requirement due to the pandemic
- Package size 100pcs
- Lead time 7-10 days
FDA Registration and Certificates