Att C Salient Characteristics - masks surgical and procedural.pdf

Medical grade surgical and procedural masks:

- Surgical masks:

o Surgical masks have ties so they can be adjusted for fit o Intended for use in sterile environments to protect the patient care environment from contamination o 3-ply: outerlayer a hydrophobic non-woven layer to repel fluids, middle layer a melt-blown material to prevent bacterial passing through mask, inner layer a soft absorbent non-woven material to absorb moisture.

o Registered with FDA (510(k) submission) for class 2 medical device to sell ‘mask, surgical’ o ASTM level 3 protection rating

- Medical grade procedure masks:

o Used for performing patient procedures or to protect staff from potential contaminants.

Protect both patient and staff from respiratory secretions, fluids and other debris o Ear loops for quick donning o 3 ply (layers) strongly preferred o Registered with FDA to sell ‘face mask’

- All medical mask (surgical and procedure mask) shared properties o Covers mouth and nose and provide a physical barrier to fluids and particulate materials.

o Materials: fabric of polypropylene- (spunbound, meltblown, or wetlaid)

Metal for nose feature Foam material Face shield materials, if any o Testing on biocompatibility of materials (ISO 10993) o Fluid resistance (ASTM F 1862 testing) conducted

Tested with 80mmHg, 120mmHG, and 160mmHg pressures

• Higher number = more protective o Particle filtration efficiency tested ASTM F 1215-89 if available o Lower number = better o Bacterial filtration efficiency tested

One of these tests conducted: Bacterial penetration (Mil-M369454C), Modified Greene and Vesley method, or ASTM F2101-01 (standard test)

Reported as a percentage of the known quantity that did not pass through the mask material at a given aerosol flow rate

Higher number = better o Differential Pressure test (delta-P) Relates to breathability and comfort of mask

• Lower delta P means increased breathability

• >5 = hot to wear, 4.0-5.0 = very warm, 3.0-4.0 = warm, 2.0-3.0 = cool, 1.0-2.0= very cool o Flammability testing

Tested with one of these standards (CPSC CS-191-53, NFPA 702-1980, UL2154) Class 1 and class 2 only acceptable levels for medical masks o Packaging clearly marked with intended use

- Non-medical face masks for patients and visitors o 3-ply preferred o Ear loops for quick donning o Main difference

Not tested for fluid resistance

Reference products:

• Surgical masks:

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam, Ties, Mediterranean Blue Material #: AT74535

Manufacturer #: 1074535

Product Description

LEVEL 3 SURGICAL MASK ANTI-FOG FOAM TIES MEDITERRANEAN BLUE

Features and Benefits:

o Meets the highest performance requirements defined by ASTM F2100-11, ASTM

Level 3 masks features a four-layer construction o Offers you protection, breathability and comfort o Not made with natural rubber latex and has a 160mmHg fluid protection rating o Inner layer is constructed with medical grade cellulose and is soft and non abrasive to the skin o Mediterranean blue outer-facing

Cardinal Health™ Level 3 Duckbill-Style Surgical Mask with Anti-Fog Foam, Ties, Mediterranean Blue Manufacturer #: 1054535

Product Description

LEVEL 3 SURGICAL MASK DUCKBILL ANTI-FOG FOAM TIES MEDITERRANEAN BLUE

Features and Benefits:

o Meets the highest performance requirements defined by ASTM F2100-11, ASTM

Level 3 masks features a four-layer construction o Offers you protection, breathability and comfort o Not made with natural rubber latex and has a 160mmHg fluid protection rating o Inner layer is constructed with medical grade cellulose and is soft and non

• Procedure masks:

Cardinal Health™ Level 3 Procedure Mask with Anti-Fog Foam, Ear Loops, Mediterranean Blue Manufacturer #: 1074531

Product Description

LEVEL 3 PROCEDURE MASK ANTI-FOG FOAM EARLOOP CLOSURE MEDITERRANEAN BLUE

Features and Benefits:

o Meets the highest performance requirements defined by ASTM F2100-11, ASTM

Level 3 masks features a four-layer construction o Offers you protection, breathability and comfort o Not made with natural rubber latex and has a 160mmHg fluid protection rating o Inner layer is constructed with medical grade cellulose and is soft and non