(59 days)
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Savewo ClassicMASKs are 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) and provided non-sterile.
Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Savewo ClassicMASK:
Description of the Acceptance Criteria and Study
The Savewo ClassicMASK is a 3-layered surgical mask intended to protect both patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The device underwent non-clinical testing to demonstrate its performance against established standards, specifically the ASTM F2100-19 standard for Level 3 surgical masks, and to ensure biocompatibility and flammability compliance. The study aims to prove substantial equivalence to a predicate device (Single-use Surgical Mask, K200923) by meeting the outlined acceptance criteria for various performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5:2009 - Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity | Non-Cytotoxic | Pass (Non-Cytotoxic) |
| Sensitization | ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization | Non-sensitizing | Pass (Non-sensitizing) |
| Irritation | ISO 10993-10:2010 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization | Non-irritating | Pass (Non-irritating) |
| Performance Tests | |||
| Bacterial filtration efficiency (BFE) (%) | ASTM F2101-19 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus | Passed at ≥98% | Lot 1: ≥99.9%, Lot 2: ≥99.9%, Lot 3: ≥99.9% |
| Particulate filtration efficiency (PFE) (%) | ASTM F2299/F2299M-03 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | Pass at ≥98% | Lot 1: ≥99.6%, Lot 2: ≥99.7%, Lot 3: ≥99.7% |
| Differential pressure (mmH2O/cm²) | MIL-M-36945C, Military Specifications: Surgical Mask, disposable | Passed at |
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.