(120 days)
The Medical Surgical Masks-Non Sterile is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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 non-sterile.
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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 non-sterile.
The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Non Sterile is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with 30% polyamide and 70% polyurethane.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The provided text describes the acceptance criteria and performance of a Medical Surgical Mask-Non Sterile. It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets criteria in an AI/algorithm context. Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or specific AI-related ground truths, are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and the device's performance based on the non-clinical tests conducted for this medical device.
Acceptance Criteria and Reported Device Performance
| Title of the Test | Acceptance criteria and source of references | Reported Device Performance (Results) |
|---|---|---|
| In Vitro Cytotoxicity | No cytotoxicity effect as the test method of ISO 10993-10 | Under the conditions of the study, not cytotoxicity effect |
| Skin Irritation | No irritation effect as the test method of ISO 10993-5 | Under the conditions of the study, not an irritant |
| Skin Sensitization | No sensitization effect as the test method of ISO 10993-5 | Under conditions of the study, not a sensitizer. |
| Fluid Resistance | 120 mmHg as the test method of ASTM F1862 | 120 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥98% as the test method of ASTM F2299 | ≥99% |
| Bacterial Filtration Efficiency (BFE) | ≥98% as the test method of ASTM F2101 | ≥99% |
| Differential Pressure (Delta P) |
§ 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.