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Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided as sterile.

The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "Medical Surgical Mask" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Lot 1: 31 Out of 32 pass at 160mmHg (21.3 kPa)
• Lot 2: 31 Out of 32 pass at 160mmHg (21.3 kPa)
• Lot 3: 32 Out of 32 pass at 160mmHg (21.3 kPa) |
  | Particulate Filtration Efficiency ASTM F2299 | Evaluate the Particulate Filtration Efficiency | ≥ 98% | Pass
• Lot 1: 99.02%-99.58%
• Lot 2: 99.05%-99.59%
• Lot 3: 99.10%-99.68% |
  | Bacterial Filtration Efficiency ASTM F2101 | Evaluate the Bacterial Filtration Efficiency | ≥ 98% | Pass
• Lot 1: 98.8%-99.7%
• Lot 2: 98.7%-99.5%
• Lot 3: 98.9%-99.5% |
  | Differential Pressure (Delta P) MIL-M-36954C | Evaluate the Differential Pressure (Delta P) |

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