(138 days)
The Disposable Medical Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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 Disposable Medical Surgical Face Masks are composed of mask body, nose clip and ear loop. The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of PE and iron wire, ear loop is made of Nylon and Spandex. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±1cm, the length of the ear loop is 18cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with non-sterile and is intended to be single use, disposable devices.
The provided document describes the acceptance criteria and study results for Disposable Medical Surgical Face Masks (K202211) manufactured by Guangdong Kaidi Garments Co., Ltd. The study focuses on demonstrating substantial equivalence to a predicate device (K153496) through non-clinical testing.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Level 2 Medical Mask) | Reported Device Performance (K202211) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 120 mmHg | 32 out of 32 per lot pass at 120 mmHg, 3 non-consecutive lots tested | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot 1: 99.68%; Lot 2: 99.56%; Lot 3: 99.81% (3 non-consecutive lots tested) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% (3 non-consecutive lots tested) | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
§ 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.