Rivex Medical
Rivex Medical

Rivex Medical LLC

Richardson, Texas · [email protected]

rivexmedical.com

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 TypeWoven cotton krinkle/fluff gauze bandage roll
Width4.5" (11.4 cm)
Length (stretched)4.1 yd (3.7 m)
Ply6-ply
Material100% cotton, pre-washed, fluff-dried
ConstructionCrinkle (Krinkle) weave
Edge TypeSelvage edge
ColorWhite
SterileYes — EO gas (ISO 11135), color-change indicator
Latex100% cotton — contains no natural rubber latex; Certificate of Analysis supplied with each lot
BleachingHydrogen peroxide (chlorine-free)
Roll WrapSterile peel-open pouch (paper/plastic, ISO 11607) with heat seal
Rolls per Box12
Box TypeFull-color printed cardboard box
Shelf Life5 years — printed expiration date on every pouch
Cotton OriginUFLPA-compliant sourcing — certificate of origin required; cotton must not originate from Xinjiang
LabelingPrivate label, UPC, UDI, lot number, sterilization method, expiration date, English/Spanish bilingual

US Regulatory Status

FDA Device ClassClass I, 510(k) exempt
Quality SystemFull 21 CFR 820 GMP with validated EO sterilization (ISO 11135) and sterile-barrier packaging (ISO 11607)
ManufacturingProduced 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].