
Product Specification Sheet
Krinkle Gauze Roll 4.5" — 6-Ply Sterile
SKU RVX-KGR-45S · Category: Gauze Rolls & Bandages · Available to quote · Made to order
Kerlix-type krinkle gauze in the hospital-standard 4.5" × 4.1 yd size: 100% cotton, pre-washed and fluff-dried into a crinkle weave that traps exudate and cushions wounds as a primary dressing. 6-ply for maximum roll absorbency. Each roll EO-sterilized in its own peel-open pouch with indicator and printed expiration.
Specification
| Product Type | Woven cotton krinkle/fluff gauze bandage roll |
|---|---|
| Width | 4.5" (11.4 cm) |
| Length (stretched) | 4.1 yd (3.7 m) |
| Ply | 6-ply |
| Material | 100% cotton, pre-washed, fluff-dried |
| Construction | Crinkle (Krinkle) weave |
| Edge Type | Selvage edge |
| Color | White |
| Sterile | Yes — EO gas (ISO 11135), color-change indicator |
| Latex | 100% cotton — contains no natural rubber latex; Certificate of Analysis supplied with each lot |
| Bleaching | Hydrogen peroxide (chlorine-free) |
| Roll Wrap | Sterile peel-open pouch (paper/plastic, ISO 11607) with heat seal |
| Rolls per Box | 12 |
| Box Type | Full-color printed cardboard box |
| Shelf Life | 5 years — printed expiration date on every pouch |
| Cotton Origin | UFLPA-compliant sourcing — certificate of origin required; cotton must not originate from Xinjiang |
| Labeling | Private label, UPC, UDI, lot number, sterilization method, expiration date, English/Spanish bilingual |
US Regulatory Status
| FDA Device Class | Class I, 510(k) exempt |
|---|---|
| Quality System | Full 21 CFR 820 GMP with validated EO sterilization (ISO 11135) and sterile-barrier packaging (ISO 11607) |
| Manufacturing | Produced in ISO 13485-certified, FDA-registered facilities |
Generated from the published product data at rivexmedical.com. Products are sourced from ISO 13485-certified, FDA-registered manufacturers; supplier documentation (Certificates of Analysis, certificates of origin, facility registrations) is provided with quotes. For pricing and lead times, contact [email protected].