Product Specification Sheet
Woven Cotton Gauze Sponge 4×4" — 12-Ply Sterile, USP Type VII, 100/Box
SKU RVX-WGS-44S · Category: Gauze Sponges & Pads · Available to quote · Made to order
12-ply woven cotton gauze sponge built to the USP Type VII specification hospitals order by name: 4×4", 100% cotton that strengthens when wet, French-folded so no raw edge ever touches the wound. Two sponges per sterile peel-open pouch with color-change indicator, EO-sterilized with full lot dating.
Specification
| Product Type | Woven cotton gauze sponge (USP Type VII) |
|---|---|
| Size | 4×4" (10×10 cm) |
| Ply | 12-ply |
| Material | 100% woven cotton, carded yarn |
| Thread Count / Mesh | 20×12 (USP Type VII) |
| Warp Threads / inch | 18–22 |
| Filling Threads / inch | 8–14 |
| Total Thread Count / 6.45 cm² | 27–35 |
| Weight | 18.1–23.1 g/m² (USP Type VII) |
| Sinking Time | ≤ 5 seconds (ASTM D1117) |
| Edge Type | Folded (French fold) — no exposed raw edges |
| 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) |
| Packaging | 2 sponges per sterile peel-open pouch (paper/plastic, ISO 11607); 50 pouches (100 pieces) per printed 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 — 21 CFR 878.4014 |
|---|---|
| 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].