(60 days)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.
Below are the configuration of each model.
GFM 96 - three-layer, flat-pleated with ear loops
GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip
GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield
GFM 88 - three-layer, flat-pleated with ties
GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip
GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield
The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.
The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
This document is a 510(k) Premarket Notification for a Surgical Mask, specifically models GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, and GFM 80, manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.
The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K210147). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical testing conducted to show the device meets specific requirements for surgical masks and is equivalent to the predicate.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria for Level 3 Barrier | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥98% | Passed (Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%) |
| Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C) | Determine breathability of the mask |
§ 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.