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Attachment B - PPE - Minimum Technical Requirements
| PPE Item |
| Requirement |
| Specification |
| Surgical Masks |
| U.S. Food and Drug Administration (FDA) Cleared, conforming to ASTM F2100-21 Standard Specification for Performance of Materials Used in Medical Face Masks (21 or most recent version, if available). Selected level (Level 1 through 3). |
| Surgical Masks or Procedure Mask, Medical grade, Pleat‐Style with Ear loops, Blue, 7 X 3.875 inches. Approved, certified, and noted on the FDA list. Regulated by the FDA and have FDA approval or FDA emergency use authorization. FDA “registration” is not sufficient – registration relates to the company, not to specific products. Masks with the FDA product code QKR are not acceptable- these masks are not FDA-cleared. ASTM classification of Level 3. |
| N95 Respirators |
| NIOSH Approved, filtering facepiece |
| NIOSH certified. Filtering ability for non-oil particles over 95% under the NIOSH Standards. |
Gowns Surgical (Sizes: XS, S, M, L, XL, XXL, XXXL)
| AAMI PB70 (Level 3 or Level 4 requirements.) Conform to ASTM F2407-22a |
| Specification for Surgical Gowns Intended for Use in Healthcare Facilities. |
Gowns Non-Surgical (Sizes: S, M, L, XL, XXL, XXXL)
| AAMI PB70 requirements. Barrier resistance level selected (level 1 through 4) Conform to ASTM F3352M-22 |
| Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities. |
| Protective Eyewear |
| ANSI Z87.1 Occupational and educational eye and face protective devices. ANSI Z87.6A2 Occupational and Educational Eye and Face Protective Devices for Preventing Exposures to Body Fluids. |
| Safety/Protective goggles, anti-fog, clear, scratch resistant, non-vented lens material polycarbonate, strap material elastic. Meet ANSI Z87.1 (2020) |
| Face Shields / Goggles |
| ANSI Z87.1 Occupational and educational eye and face protective devices. |
| FDA approved wide lens material, Safety Face Shield Full Face, Sturdy, 11” x 10” polycarbonate shield, Washable and Reusable, Comfortable built-in foam and adjustable elastic band, meet OSHA 1910.133 and ANSI Z87.1 (2020) |
| Hair / Shoe Covering |
| Non-rated, polypropylene |
| FDA approved for hospital setting |
| Garments/Coveralls |
| Tyvek Coveralls or equivalent. Full body, zipper closure with attached hood. Microporous protection from dirt, grease, grime, and light chemical splash. |
| Tyvek Coveralls or equivalent. Full body, zipper closure with attached hood. Microporous protection from dirt, grease, grime, and light chemical splash. Size Large (50%) and XL (50%) |
