| 1 | Company identity and manufacturing role | Business license, registered address, factory address, and a written description of which production steps are performed in-house. | Check the company’s registration details through China’s National Enterprise Credit Information Publicity System. Confirm that the legal entity on the license matches the entity on quotations, contracts, and invoices. | Clarify whether the supplier is a manufacturer, trading company, or a combination. Do not treat a trading address as proof of a production site. |
| 2 | Applicable product standard | The exact standard and edition claimed for each model. For Chinese non-powered particulate respirators, ask whether the product is tested to GB 2626-2019 and which class is claimed. | Check that the model, standard, class, manufacturer, and test samples in the supporting documents match the product being quoted. KN95 is a class under GB 2626; it is not the same designation as NIOSH-approved N95. | Specify the destination market and intended protection before comparing quotations. Do not compare products solely by a “95” label. |
| 3 | Test reports and laboratory scope | Complete, current test reports for the exact model, including report number, date, test results, sample identification, and laboratory details. | Contact the issuing laboratory using independently sourced contact details. If accreditation is claimed, check the laboratory’s accreditation scope and status with the relevant accreditation body; an accreditation logo alone is not proof. | Request clarification or independent testing if reports are incomplete, unverifiable, or refer to a different model or factory. |
| 4 | European Union conformity, when applicable | EU Declaration of Conformity, applicable EU type-examination certificate, and details of the conformity-assessment route for the respirator. | For PPE placed on the EU market, check the applicable requirements of Regulation (EU) 2016/425. Verify the notified body and its scope in the European Commission’s NANDO database, and confirm certificate details with the issuing body. | Confirm that the documents cover the exact product and that required production-surveillance arrangements are in place. A CE mark by itself does not demonstrate this. |
| 5 | U.S. NIOSH approval, when applicable | The NIOSH approval number and the complete approval details for any product represented as NIOSH-approved. | Search the NIOSH Certified Equipment List (CEL) and compare the approval holder, model, and configuration with the offered product. | Do not accept “N95 equivalent” as evidence of NIOSH approval. N95 is a NIOSH respirator classification; other standards use different test and approval systems. |
| 6 | Product specifications and intended use | Model-specific data sheet covering filtration classification, intended use, limitations, sizes, materials, and storage conditions. | Compare the data sheet with the test report, product labeling, instructions, and samples. Check that claims are consistent across all documents. | Particulate respirators are not automatically suitable for gases or vapors. Select protection based on the hazard assessment and the relevant market requirements. |
| 7 | Fit and wearer compatibility | Samples in the proposed styles and sizes, plus instructions for donning, seal checks, and use limitations. | Evaluate fit on intended users. Respirator fit depends on the wearer and model; a good filtration test result does not establish a good face seal for every person. | Arrange wearer fit testing where required by the applicable workplace rules. Do not rely on appearance or a one-size-fits-all claim. |
| 8 | Quality management and batch controls | Quality procedures, incoming-material checks, production inspection records, finished-product release criteria, and a sample batch record. | Review records during a factory audit or remote assessment. Check that production and inspection records can be linked to a specific model and lot. | Prefer suppliers able to explain and document how nonconforming products are identified, controlled, and corrected. |
| 9 | Traceability, packaging, and labeling | Artwork and packaging samples showing manufacturer details, model, applicable standard, lot or batch identification, date information where required, and instructions. | Cross-check the packaging and product markings against the approved documents and the destination market’s labeling rules. Confirm how a production lot can be traced back to records. | Approve final artwork and product identification before mass production. Treat unexplained differences between samples and shipment packaging as a hold point. |
| 10 | Commercial terms and pre-shipment controls | Written quotation, sample approval process, minimum order quantity, lead time, inspection terms, packaging details, and agreed remedies for nonconformity. | Place a small trial order where practical. Use a written purchase specification and consider independent pre-shipment inspection against the approved sample and documents. | Release bulk orders only after product, documentation, quality criteria, and delivery terms are agreed in writing. |