(157 days)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. This face mask 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 provided non-sterile.
Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates. Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Surgical Mask (K210267). It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable Surgical Mask, K210267) is a surgical mask intended to meet Level 2 performance according to ASTM F2100:2019. The acceptance criteria and the device's reported performance are summarized in the table below:
| Test Item | Test Method | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration Resistance | ASTM F1862/F1862M-17 (according to ASTM F2100:2019) | Pass at 120 mmHg | 32/32 passed at 120 mm/Hg (Pass) |
| Flammability of Clothing Textiles | 16 CFR Part 1610 (according to ASTM F2100:2019) | Class 1 (≥3 Seconds burn time) | 32/32 Passed ≥3 Seconds burn Time-Class 1 (Pass) |
| Differential Pressure (Delta P) | EN 14683: 2019, Annex C (according to ASTM F2100:2019) |
§ 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.