| Raw-material supply | Polypropylene resin, spunbond and meltblown webs, elastic components, films, absorbent materials, and packaging materials. | Inputs for masks, protective apparel, surgical drapes, caps, shoe covers, and other single-use medical products. | Material specifications, supplier qualification, incoming inspection, traceability, and control of changes to approved materials. |
| Nonwoven fabric production | Spunbond, meltblown, and composite processes such as SMS, which combines spunbond and meltblown layers. | Barrier, filtration, and cover-stock fabrics used as components in disposable medical products. | Web uniformity, basis weight, strength, filtration or barrier performance, and batch-to-batch consistency. Required properties depend on the intended product. |
| Converting and product assembly | Cutting, folding, sewing, ultrasonic bonding, heat sealing, lamination, and attachment of fasteners or elastic parts. | Surgical gowns, isolation gowns, masks, caps, drapes, protective coveralls, and procedure packs. | Product design controls, seam and closure integrity, dimensional checks, cleanliness, and documented production controls. |
| Testing and quality assurance | In-house inspection and, where needed, testing by qualified external laboratories. | Verification of finished products and fabric components against their intended use and applicable specifications. | Test selection may include filtration, fluid resistance, particle or microbial barrier performance, tensile strength, and biocompatibility, as applicable to the product. |
| Sterilization and packaging | Product-specific packaging, sterilization where required, and release of finished goods. | Sterile or non-sterile disposable products, according to product design and intended use. | Sterilization validation and sterile-barrier packaging controls apply when a product is supplied sterile. Not all medical nonwoven products are sterile. |
| Regulatory and management systems | Quality management, risk management, product registration or filing, technical documentation, and post-market processes. | Documentation and controls supporting the manufacture and sale of regulated medical devices. | ISO 13485 addresses medical-device quality management systems; ISO 14971 addresses medical-device risk management. Applicable Chinese requirements depend on product classification and intended use. |
| Standards used for product specifications | Product-specific national, international, or market-access requirements. | Examples include medical masks, medical protective clothing, and surgical gowns or drapes. | Examples include China’s GB 19083-2010 for medical protective masks, GB 19082-2009 for single-use medical protective clothing, EN 14683 for medical face masks, and EN 13795-1 for surgical clothing and drapes. Confirm the current edition and applicability for each product and market. |
| Sales and distribution | Domestic medical procurement, distributors, institutional buyers, and export channels. | Finished disposable products supplied to healthcare settings and other permitted end users. | Market-specific registration, labeling, language, packaging, and documentation requirements should be checked before distribution. |