(116 days)
The 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 sterile.
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 ear loops welded to the facemask. The loops are made of Nylon and spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold sterilized and are intended to be single use, disposable devices.
The provided text describes the non-clinical performance testing for a surgical face mask (Trade Name: Surgical Face Mask, Model: Earloop17.5*9.5cm, K212264) to demonstrate its substantial equivalence to a predicate device (Kimberly-Clark KC100 Mask, K110455).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 2 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 2) | Result of LOT-WK20201006 | Result of LOT-WK20201204 | Result of LOT-WK20201208 |
|---|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C, ASTM F2100-19) |
§ 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.