Compliance documentation and certifications
Quality Assurance

Certifications & Compliance. Verified at Every Stage.

Every product ships with documentation, not just claims. FDA food contact, ASTM material testing, BPI compostability, ISO 9001 quality systems, and factory-level quality verification built into every order.

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Standards We Verify

The Standards That Matter

Named certifications. Documented test results. No vague compliance claims.

FDA 21 CFR 177/176

Food contact compliance for all food service grade products. Covers polymer, paper, and coating substrates. Verified per production lot with test documentation on file.

ASTM D6319 / D5250

Standard specification for nitrile (D6319) and vinyl (D5250) examination gloves. Covers tensile strength, elongation, and barrier integrity. Third-party test reports available per lot.

ASTM D6400 / D6868

Standard specification for compostable plastics (D6400) and biodegradable coatings on paper substrates (D6868). Required for BPI certification. Verified through independent lab testing.

BPI Certification

Biodegradable Products Institute certification for commercial compostability. The standard that validates whether a product will actually break down in a commercial composting facility.

FSC Certification

Forest Stewardship Council certification for responsibly sourced paper products. Chain of custody documentation verifies the fiber origin from certified forests through production.

EN 455

European standard for medical gloves covering freedom from holes (AQL), physical properties, and biological evaluation. Required for export markets and medical-grade applications.

Quality Process

How We Verify

Compliance is not a checkbox at the end of the process. It is built into every stage.

Factory Qualification

Before any factory enters our network, we verify FDA registration, confirm ISO 9001 certification, audit quality management systems, and run trial production to validate consistency.

Pre-Production Inspection

Raw material verification, production line setup confirmation, and specification review before production begins. Issues are caught before they become defects.

During-Production QC

In-line quality checks at key production milestones. AQL sampling per MIL-STD-1916 or equivalent. Real-time communication with factory quality teams.

Pre-Shipment Inspection

Final inspection before container loading. Visual inspection, dimensional checks, packaging verification, and documentation review. Independent third-party inspection reports issued.

Documentation

What Ships With Every Order

Complete documentation so your compliance team has what it needs before the product hits your dock.

Certificate of Analysis

Per-lot test results confirming material properties meet specification requirements

Certificate of Conformance

Manufacturer attestation that the production run meets all stated specifications

FDA Registration Verification

Confirmation of active FDA facility registration and 510(k) clearance verification for all food contact and medical device products

ASTM Test Reports

Independent laboratory test results for applicable ASTM standards per product category

Lot Traceability

Full production traceability from raw material batch through finished goods container shipment

Import Documentation

Bill of lading, packing lists, customs documentation, and country of origin certificates managed end-to-end

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