Clenivax™ is fully compliant with the AORN Guidelines for Perioperative Practice (2025), Guideline for Preoperative Patient Skin Antisepsis.

Key Compliance Points

• Recommended Agent: CHG 2% with Isopropyl Alcohol 70% — designated preferred preoperative skin antiseptic for intact skin.
• Persistent Activity: CHG provides residual antimicrobial effect lasting >6 hours post-application, exceeding AORN minimum requirements.
• Application Technique: Clenivax™ applicator design supports AORN-recommended two-step, back-and-forth friction technique for full-contact coverage.
• Drying Time: Allows full evaporation of isopropyl alcohol before draping, consistent with AORN fire-safety protocols (minimum 3 minutes).
• Sterile Field Protection: Single-use, sterile applicator eliminates risk of cross-contamination in the perioperative field.

Referenced Standards

• AORN Guideline for Preoperative Patient Skin Antisepsis (2025 Edition)
• AORN Guideline for Prevention of Retained Surgical Items
• CDC Guideline for Prevention of Surgical Site Infection (2017)

Full compliance documentation and AORN guideline cross-reference available upon request from your Clenivax™ clinical specialist.

Clenivax™ is an FDA-cleared Class II medical device (510(k) premarket notification) manufactured under 21 CFR Part 820 Quality System Regulations.

Regulatory Classification

• Device Class: Class II — Surgical Skin Antiseptic
• Product Code: KZG / OTC Topical Antiseptic
• Regulation Number: 21 CFR 333.470
• Establishment Registration: FDA-registered manufacturing facility

Formulation & Sterility

• Active Ingredients: Chlorhexidine Gluconate 2% w/v + Isopropyl Alcohol 70% v/v
• Sterilization Method: Ethylene Oxide (EO) — ISO 11135 validated
• Sterility Assurance Level (SAL): 10⁻⁶
• Biocompatibility: ISO 10993 tested — cytotoxicity, sensitization, and irritation
• Shelf Life: 36 months from date of manufacture (unopened)
• Lot Traceability: Full UDI (Unique Device Identification) compliant with 21 CFR 830

Quality System

• Manufactured under ISO 13485:2016 Quality Management System
• USP <71> Sterility Testing on every production lot
• cGMP compliant — 21 CFR Part 820

Certificate of Analysis, Sterility Test Reports, and 510(k) summary available to qualified healthcare institutions.

Surgical Site Infections (SSIs) affect approximately 2–5% of patients undergoing inpatient surgery. Clenivax™ is engineered as the evidence-based choice within multi-modal SSI prevention bundles.

Clinical Evidence

• CHG vs. Povidone-Iodine: Meta-analysis of 13 RCTs (n=2,623) demonstrates CHG-alcohol reduces SSI rates by up to 41% compared to povidone-iodine scrub/paint (Darouiche et al., NEJM 2010).
• Persistent Bactericidal Activity: Residual CHG activity suppresses gram-positive and gram-negative organisms for >6 hours, critical for procedure duration protection.
• Broad Spectrum Coverage: Effective against MRSA, VRE, Candida spp., and common surgical pathogens per EUCAST/CLSI breakpoints.

Protocol Integration

• SCIP (Surgical Care Improvement Project): Clenivax™ supports Inf-6 measure — appropriate hair removal and skin prep.
• WHO SSI Bundle (2016): Aligned with WHO recommendation for alcohol-based antiseptic on clean-contaminated and clean wounds.
• The Joint Commission: Supports NPSG.07.05.01 — hand hygiene and SSI prevention measures.
• HICPAC/CDC (2017): Supports Category IA recommendation for alcohol-based antiseptic preparation.

Supported Procedure Types

• Orthopedic implant procedures · Cardiac surgery · Neurosurgery
• General abdominal procedures · Laparoscopic surgery · Vascular access

Full clinical dossier with 60+ referenced studies available for Infection Prevention & Control committees.

Clenivax™ provides a complete clinical education ecosystem to ensure correct technique, compliance documentation, and ongoing institutional support.

Education & Training

• On-Demand Video Library: Step-by-step technique videos for each applicator size, available in English and Spanish.
• In-Service Training: Dedicated clinical specialists available for OR team in-services, including hands-on applicator technique workshops.
• CE Credits: Accredited continuing education modules for OR nurses and surgical technologists (CNOR, CST).
• LMS Integration: SCORM-compliant e-learning modules compatible with hospital learning management systems.

Documentation Package

• eIFU (Electronic Instructions for Use): Multi-language, always current — per EU MDR 2017/745 and FDA 21 CFR 801.
• SDS / MSDS: Safety Data Sheets per GHS/OSHA HazCom 2012 and EU REACH Regulation.
• Product Labels: UDI-compliant labeling per FDA 21 CFR 830 and EU IVDR Annex VI.
• Compliance Toolkit: Policy templates, audit checklists, and formulary justification documents.

Clinical & Customer Support

• Clinical Hotline: 24/7 nurse-staffed clinical support line for procedural questions.
• Medical Affairs: Direct access to Medical Science Liaisons (MSLs) for peer-to-peer clinical dialogue.
• Account Management: Dedicated rep for formulary support, contracts, and reorder management.

Contact your Clenivax™ representative or visit the online portal to access the full resource library.