| 1 | Intended use and product type | Clarify whether the product is an occupational particulate respirator, a general-purpose mask, or a medical face mask. These categories have different performance and regulatory requirements. | Product specification, intended-use statement, labeling, and applicable market rules. | Do not assume that a product marketed as a “dust mask” is approved for every workplace, medical, or public-health use. |
| 2 | Chinese standard claims | For products claiming compliance with China’s GB 2626-2019, check the stated classification and confirm that the test evidence applies to the exact product model. | GB 2626-2019 is China’s standard for respiratory protective equipment—self-priming filtering particulate respirators. Ask for the complete test report and model details. | A Chinese standard claim does not, by itself, establish approval under EU, US, or other destination-market requirements. |
| 3 | EU requirements | For an EU PPE claim, check the applicable conformity assessment, product documentation, labeling, and ongoing production-surveillance requirements. | EN 149:2001+A1:2009 covers filtering half masks to protect against particles and includes FFP1, FFP2, and FFP3 classifications. Request the EU declaration of conformity and relevant notified-body documentation. | Check that certificates and reports identify the same manufacturer, model, and configuration as the goods being ordered. |
| 4 | US NIOSH approval | If a respirator is offered as NIOSH-approved, verify its approval number, approved manufacturer, and exact model. | Check the NIOSH Certified Equipment List and the approval label. NIOSH approval is governed by the applicable US respirator approval requirements, including 42 CFR Part 84. | A filtration test result or a “N95-like” description is not a substitute for verifying an actual NIOSH approval. |
| 5 | Certificate and report authenticity | Confirm the issuing body, report number, test date, scope, model identification, and whether the document can be independently verified. | Full laboratory reports and certificates, with consistent product and manufacturer details across documents. | A certificate for a similar-looking product or a different factory does not automatically cover the shipment under negotiation. |
| 6 | Product performance and fit | Review the claimed filtration performance alongside breathing resistance, fit, leakage, strap design, and intended wear conditions. | Applicable standard test results, samples, product drawings, and user instructions. | For workplace use, product selection and fit-testing obligations depend on the destination country and employer’s respiratory-protection program. |
| 7 | Quality management and production controls | Assess incoming-material checks, process controls, finished-product inspection, nonconformance handling, and traceability. | Quality procedures, audit records, inspection plans, and any current quality-management-system certificate within its stated scope. | ISO 9001 certification concerns a quality management system; it is not, by itself, product approval or proof of respirator performance. |
| 8 | Batch traceability and change control | Check whether each batch can be traced and whether changes to materials, tooling, production location, or design are documented and controlled. | Batch codes, production records, change-control procedures, and a written process for notifying buyers of material changes. | Define approval requirements for substitutions in the purchase contract, particularly where the product is tied to a certification or regulatory submission. |
| 9 | Packaging, labeling, and shipping | Confirm packaging protects the goods in transit and that labels and user information meet the requirements of the destination market. | Approved artwork, carton specifications, packing list, commercial invoice, and shipment documents. | Agree on language, importer details, product markings, carton quantities, Incoterms, and responsibility for freight and insurance before production. |
| 10 | Import classification and landed cost | Determine the correct tariff classification and confirm applicable duties, taxes, customs documentation, and any product-specific import controls. | Destination-country customs guidance and advice from a qualified customs broker based on the product’s construction and intended use. | Do not rely on a generic HS code: classification and duty treatment can vary by jurisdiction and product details. Verify requirements before placing a bulk order. |