(188 days)
The Following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile.
3-ply EcoGuard B with Earloop, Model Number: ECO01
3-ply EcoGuard B with Tie-on, Model Number: ECO02
The proposed surgical masks are available in two models with three-ply pleated earloop or tie-on (EcoGuard B) masks with ear loops and nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops or ties are held in place over the users' mouth and nose by two elastic ear loops or four ties welded to the surgical mask. Neither the elastic ear loops, nor ties are made with natural rubber latex. The nose piece in the layers of surgical mask is to allow the user to fit the surgical mask around their nose, which is made of malleable polyethylene wire. The surgical masks are sold nonsterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification summary for a surgical mask (EcoGuard B). It assesses the substantial equivalence of the new device to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and biocompatibility testing, not clinical studies involving human patients or complex AI algorithm evaluation.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (EcoGuard B) | Average |
|---|---|---|---|---|
| ASTM F1862 Synthetic Blood Penetration | Determine synthetic blood penetration resistance | Level III (Pass at 160 mmHg) | Pass at 160 mmHg (95/96) (32 samples each from 3 lots) | N/A |
| ASTM F2101 Bacterial Filtration Efficiency | Determine the bacterial filtration efficiency | ≥ 98% | Pass (96/96) (32 samples each from 3 lots) | 99.9% |
| ASTM F2299 Particulate Filtration Efficiency at 0.1 micron | Determine submicron particulate filtration efficiency | ≥ 99% | Pass (96/96) (32 samples each from 3 lots) | 99.8% |
| Mil-M-36954C Delta P (Breathing Resistance) | Determine breathing resistance or differential pressure |
§ 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.