| 1 | Define the intended use | Identify the procedure, user, body area, expected exposure, and whether the item is for patient care, isolation, or surgery. | Product intended-use statement, applicable market authorization, and instructions for use (IFU). Requirements vary by product type and country. | Match the product’s labeled use to the facility’s procedure and risk assessment; do not select by material name alone. |
| 2 | Set the required barrier level | Estimate the amount of fluid exposure and the likelihood of contact with potentially infectious material. | For surgical gowns in the United States, check the labeled ANSI/AAMI PB70 barrier level (Levels 1–4) and the specified critical zones. Confirm the applicable standard edition and market requirements. | Compare the labeled level with the expected exposure. A higher level is not automatically necessary for every task. |
| 3 | Choose the right mask or respirator category | Distinguish a procedure or surgical mask from a respirator. They are designed for different protection purposes. | For medical face masks, review applicable performance claims, such as ASTM F2100 classification where relevant. For respirators, verify the required approval and model designation, such as NIOSH approval in the United States. | Confirm that the product type matches the exposure-control policy. A loose-fitting medical mask is not a substitute for a required fit-tested respirator. |
| 4 | Review the complete performance profile | Check the performance characteristics relevant to the product and intended task—not just one headline rating. | Depending on the item, review fluid resistance, bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), differential pressure, linting, and other claimed test results. | Request test reports that identify the method, result, sample, and date. Compare products using the same test method and conditions. |
| 5 | Evaluate material construction | Identify the nonwoven structure and any film, coating, or laminate used to achieve the claimed performance. | Common constructions include spunbond, meltblown, spunbond-meltblown-spunbond (SMS), and laminated materials. Construction alone does not establish a protection level. | Check the specification and test evidence for the finished product, since seams, closures, and converted areas can affect performance. |
| 6 | Check fit, coverage, and design | Assess size range, coverage, mobility, closure type, cuff design, ties or fasteners, and compatibility with other PPE. | Review product dimensions, size chart, design drawings or samples, and any applicable critical-zone information in the IFU. | Conduct a wear and task trial with representative users. Confirm that the item stays in place and allows required movement. |
| 7 | Confirm comfort and usability | Consider breathability, heat build-up, softness, noise, visibility, and wear duration. | Review available air-permeability or differential-pressure data where relevant, plus user instructions and documented wearer feedback. | Evaluate comfort alongside protection needs; do not treat comfort claims as evidence of barrier performance. |
| 8 | Verify sterility and packaging needs | Determine whether the product must be sterile or non-sterile and how it will be stored and opened at the point of use. | Check the sterile or non-sterile label, sterilization information where applicable, packaging integrity, lot identification, and stated shelf life or expiry date. | Inspect packaging on receipt and before use. Follow the manufacturer’s storage conditions and do not use damaged or expired sterile packs. |
| 9 | Assess skin-contact and chemical information | Identify the type and duration of skin contact and any known sensitivities among users or patients. | Review material composition, relevant biocompatibility information for the intended contact, and claims about latex, dyes, or other substances where applicable. | Request supporting documentation for specific claims and assess it against the product’s intended use and local regulatory requirements. |
| 10 | Plan quality, supply, and lifecycle controls | Consider lot consistency, traceability, delivery reliability, packaging waste, and disposal requirements. | Review lot and date coding, product specifications, change-notification practices, quality documentation, case-pack quantities, and local disposal guidance. | Approve samples before routine purchasing, define incoming checks, and reassess the product after material, design, or manufacturing changes. |