(123 days)
The Velguard Surgical Face Mask is intended to be worn to protect 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, provided nonsterile.
The Velguard Surgical Face Mask is a single use, three pleated, flat-folded rectangular masks with ear loops and adjustable nose wire. The Surgical 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 inner spun-bond polypropylene layer uses no colorant. The outer spun-bond polypropylene layer uses a blue colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene coated zinc wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Velguard Surgical Face Mask:
The document is an FDA 510(k) summary for the Velguard Surgical Face Mask (K210761). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through a comprehensive clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Predicate K182515 Performance or Standard) | Reported Device Performance (Velguard Surgical Face Mask K210761) | Comparison / Outcome |
|---|---|---|---|
| Performance Testing (ASTM F2100-19 Level 3) | Subject device exceeded predicate device in one performance test. ASTM F2100-19 uses a different test method for measuring Delta-P (H2O/cm2). | ||
| Fluid Resistance (ASTM F1862) | 32/32 passed at 120 mmHg | Three lots passed at 160mm Hg | Similar; subject device exceeded fluid resistance of the predicate device. |
| Particulate Filtration Efficiency (ASTM F2299) | Pass at 99.7% @ 0.1 micron | Three lots passed at ≥98% @ 0.1 micron | Similar; both devices meet ASTM F2299. |
| Bacterial Filtration Efficiency (ASTM F2101) | Pass at 99.9% | Three lots passed at ≥98% | Similar; both devices meet ASTM F2101. |
| Differential Pressure (EN 14683:2019, Annex C and ASTM F2100-19) | 4.0 mmH2O/cm2 (MIL-M-36954C) | Three lots passed at |
§ 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.