Key Considerations for Selecting Disposable Coveralls Complying with GB/T 38462 Standard

For medical professionals and support staff in healthcare settings, selecting disposable coveralls that meet GB/T 38462-2020—China’s national standard for nonwoven fabrics used in isolation gowns—is critical to ensuring protection against infectious agents. This guide outlines technical specifications, performance metrics, and compliance requirements to help institutions make informed decisions.

Understanding GB/T 38462-2020: Scope and Core Requirements

GB/T 38462-2020 applies to nonwoven fabrics designed for disposable isolation gowns worn by healthcare workers and visitors. The standard categorizes materials into four grades (Ⅰ, Ⅱ, Ⅲ, Ⅳ) based on intended use, with higher grades offering enhanced protection for high-risk scenarios. Key requirements include:

Protection Performance Metrics

• Liquid Resistance: Materials must withstand synthetic blood penetration (≥60 kPa pressure) and maintain surface anti-wetting (≥Grade 4 under GB/T 4745). Critical areas like seams must resist hydrostatic pressure ≥385 cmH₂O (GB/T 24218.16).
• Microbial Barrier: Fabrics must block microbial penetration, tested using Phi-X174 bacteriophage (YY/T 0689-2008).
• Particle Filtration: While not explicitly requiring particle filtration like GB 19082-2009, materials must minimize fiber shedding to prevent contamination.

Comfort and Durability

• Breathability: Moisture permeability should exceed 4,200 g/(m²·24h) (GB/T 12704.1-2009) to reduce heat stress during prolonged use.
• Strength: Key areas must demonstrate tensile strength ≥65 N (longitudinal) and ≥170 N (transverse) (GB/T 24218.3), with elongation ≥15% to prevent tears during movement.
• Anti-Static Properties: Surface resistivity must comply with GB/T 12703.4 to minimize static discharge risks in flammable environments.

Structural Design and Ergonomic Features

GB/T 38462-2020 emphasizes design elements that enhance protection without compromising mobility:

Seal Integrity

• Elastic Cuffs/Ankles: Prevent particle ingress at wrists and ankles, critical for procedures involving aerosols or splashes.
• Hood and Waist Closures: Adjustable hoods with elastic or drawstring closures ensure compatibility with masks and respirators. Waistbands may use elastic or tie systems to accommodate varying body shapes.

Material Composition

• Composite Structures: Many coveralls combine polypropylene nonwovens with polyethylene films to balance barrier properties and breathability. For example, a 50 gsm spunbond-meltblown-spunbond (SMS) laminate offers high filtration efficiency while maintaining comfort.
• Weight and Thickness: Higher-grade materials (e.g., Ⅳ-grade) may use heavier fabrics (≥70 gsm) to withstand prolonged exposure to bodily fluids.

Visibility and Compatibility

• Clear Panels: Optional transparent windows on hoods improve visibility for tasks requiring precision, such as IV insertion.
• Glove Integration: Extended cuffs ensure overlap with gloves, creating a continuous barrier against contamination.

Compliance and Certification Process

To verify adherence to GB/T 38462-2020, focus on the following:

Documentation and Labeling

• Technical Files: Manufacturers must provide test reports for liquid resistance, microbial barrier, and tensile strength. These documents should reference standards like GB/T 24218.16 (hydrostatic pressure) and YY/T 0689-2008 (microbial penetration).
• Product Labels: Labels must include the standard number (e.g., “GB/T 38462-2020”), grade level (Ⅰ–Ⅳ), and expiration date. Sterilized products should specify the method (e.g., ethylene oxide or radiation).

Regulatory Approvals

• Class II Medical Device Registration: For coveralls used in high-risk settings (e.g., COVID-19 wards), ensure the manufacturer holds a valid registration from China’s National Medical Products Administration (NMPA).
• Third-Party Testing: Look for products tested by accredited laboratories (e.g., CNAS-certified facilities) to confirm compliance with key metrics like synthetic blood penetration and seam strength.

Storage and Handling

• Packaging: Coveralls should be sealed in moisture-proof bags to prevent contamination before use.
• Shelf Life: Check expiration dates, as material degradation (e.g., reduced tensile strength) can compromise protection over time.

Adapting to Evolving Risks and Industry Trends

GB/T 38462-2020 is periodically updated to address emerging pathogens and feedback from healthcare providers. For instance, recent amendments have introduced stricter requirements for:

Nanoscale Particle Filtration

Some revisions now include tests for viral particles smaller than SARS-CoV-2, ensuring materials block airborne transmission of high-consequence pathogens.

Sustainability

Manufacturers are increasingly offering biodegradable nonwovens or recyclable packaging to align with China’s green development goals. While these options may not yet be widespread, they represent a growing trend in the industry.

Customization for Specialized Use

Modular designs with detachable hoods or boot covers allow hospitals to customize coveralls for specific departments (e.g., oncology vs. emergency rooms), balancing protection and cost efficiency.

By prioritizing these technical, structural, and compliance factors, healthcare facilities can select GB/T 38462-2020-compliant coveralls that safeguard workers without compromising comfort or operational efficiency. Staying informed about updates to the standard ensures ongoing protection against evolving infectious threats.

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