NEWS

The $3.68 Billion Disposable Gown Market Demands Smarter Procurement

The global disposable isolation gown market surged to $3.68 billion in 2023, yet B2B buyers face increasing complexity in navigating safety standards. With FDA and ASTM compliance now non-negotiable, healthcare facilities risk safety breaches and regulatory penalties by overlooking critical certifications.

Decoding AAMI Protection Levels

• Level 1 (Minimal Risk): Basic care, visitor gowns (Example use cases)

• Level 2 (Low Risk): Blood draws, suturing

• Level 3 (Moderate Risk): ER procedures, IV insertion

• Level 4 (High Risk): Fluid-intensive surgeries, pathogen exposure (AAMI Level 4 details)

Critical Insight: Over 50% of non-traditional suppliers’ gowns failed liquid barrier tests in recent ECRI studies.

Bulk Buying: Beyond Cost Savings

• Valid FDA 510(k) clearance (Codes: FYA/FYC)

• ISO 13485 & CE certifications

• Minimum 3-year shelf life guarantees

• Transparent test reports for ASTM F2407 compliance

⚠️ Procurement Pitfalls:

• Choosing price over AAMI level appropriateness

• Decentralized purchasing without approved vendor lists

• Ignoring staff feedback on gown comfort/functionality

INTCO Medical’s Bulk Advantage

• Volume discounts

• FIFO-compatible phased deliveries

• Digital inventory tracking integrations

Pro Tip: Always request physical samples for real-world fluid resistance testing before bulk commitments.