Quality Certifications & Compliance Standards

All MEGA USA products are manufactured by MEGA Plásticos S.A. (Paraguay) under documented quality controls and certified to international standards. Our certifications cover the full disposable medical supplies line — from bouffant caps and gowns to shoe covers — ensuring every product meets the requirements of medical, laboratory, food processing, and industrial environments in the United States.

  • FDA Certified Medical Supplies

    MEGA Plásticos S.A. is registered with the U.S. Food and Drug Administration pursuant to U.S. Code of Federal Regulations, CFR Title 21, Part 807. Establishment Owner/Operator Number: 10091952. Registration certified as valid by FDA Listing Inc., New York, USA.

  • ISO 9001:2015 — Quality Management

    Certificate PY24/00000028 issued by SGS for the manufacturing activities of MEGA Plásticos S.A. Covers nonwoven fabric manufacturing (Fabricación de Telas No Tejidas). Valid from November 2024. This certification confirms that our production processes meet international quality management standards consistently across all batches.

  • SGS — Independent Quality Verification

    Product testing and quality management audits conducted under SGS protocols, ensuring compliance and consistency across our entire ISO certified disposable PPE line.

Documentation Available Upon Request

Full technical sheets, certificate copies, and product spec files are available for facilities that require compliance documentation before purchasing. Contact our team at info@megaplasticos.us for compliance inquiries or facility-specific requirements.

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