| 1 | Product Classification | Confirm whether the breathing strip is marketed as a general consumer product, cosmetic accessory, medical device, or another regulated product. | The product classification and intended use are clearly defined for the target sales market. | Product specification, intended-use statement, regulatory assessment, and export-market requirements. |
| 2 | Material Safety | Review the skin-contact adhesive, carrier material, release liner, inks, and any added ingredients. | Materials are traceable and supported by safety documentation suitable for skin-contact products. | Material declarations, safety data sheets where applicable, restricted-substance reports, and supplier traceability records. |
| 3 | Adhesive Performance | Assess initial adhesion, holding power, residue, removal comfort, and performance under sweat and normal movement. | Adhesive performance is tested under defined conditions and is consistent between production batches. | Internal test methods, batch test reports, sample evaluations, and documented acceptance criteria. |
| 4 | Skin Compatibility | Check whether the finished product has been evaluated for irritation and sensitization risks. | The manufacturer can provide relevant finished-product safety or biocompatibility testing from a competent laboratory. | Skin-irritation or sensitization test reports, laboratory qualifications, and usage warnings. |
| 5 | Quality Management System | Evaluate incoming-material control, production inspection, nonconformity handling, and corrective actions. | A documented quality system operates across purchasing, production, inspection, storage, and shipment. | Quality manual, process-control records, inspection plans, audit reports, and applicable certifications such as ISO 9001. |
| 6 | Production Capability | Confirm converting, coating, die-cutting, printing, packaging, and inspection capabilities. | The facility can maintain the required dimensions, adhesive placement, packaging format, and order volume. | Factory audit, equipment list, production-flow chart, capacity statement, and sample production records. |
| 7 | Customization Capability | Review available sizes, shapes, colors, materials, packaging formats, and private-label options. | Custom specifications are confirmed through approved drawings, samples, and written quality standards before mass production. | Technical drawings, pre-production samples, artwork approval, packaging specifications, and change-control records. |
| 8 | Testing and Inspection | Determine how the manufacturer checks dimensions, appearance, adhesion, packaging integrity, and labeling. | Inspection criteria are measurable, documented, and applied to incoming, in-process, and finished goods. | Inspection checklist, sampling plan, calibration records, certificate of analysis, and final inspection report. |
| 9 | Packaging and Shelf Life | Check individual packaging, moisture protection, storage conditions, lot coding, and shelf-life information. | Packaging protects adhesive performance and provides traceable production and batch information. | Packaging artwork, stability or shelf-life data where applicable, storage instructions, and lot-traceability procedure. |
| 10 | Commercial Reliability | Evaluate minimum order quantity, lead time, payment terms, communication, after-sales support, and complaint handling. | Commercial terms are transparent, delivery commitments are documented, and quality complaints have a defined response process. | Quotation, purchase agreement, production schedule, service-level terms, corrective-action records, and customer references. |