(94 days)
The medical surgical mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks 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), provided non-sterile.
The medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.
The document provided pertains to a 510(k) premarket notification for a Medical Surgical Mask. It demonstrates substantial equivalence to a predicate device based on non-clinical performance testing. The device is a "Medical Surgical Mask" (K212867) from Nanchang Kanghua Health Materials Co., Ltd. and its predicate device is "Disposable Surgical Face Mask" (K153496) from Xiantao Rayxin Medical Products Co., Ltd.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose | Acceptance Criteria (Level 2) | Reported Device Performance (Level 2) | Comparison |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) ASTM F2101-19 | Evaluate BFE | BFE ≥ 98% | Lot A: 99.9%, Lot B: 99.875%, Lot C: 99.9% (3 non-consecutive lots, 32 samples/lot) | Meets/Exceeds Acceptance Criteria |
| Differential Pressure (Delta-P) EN 14683:2019, Annex C | Evaluate 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.