(393 days)
The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face mask and dental face mask.
Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transms, bodily fluids and particulate material.
The Cross Protection® ResQ300 Plus Surgical Facemask is a pleated, multi-ply design, which is a nonsterile, single use, disposable device. The mask covers the nose and mouth and is secured to the face using the attached ear loops or attached ties.
The outer layer is made of 100% blue spun-bond polypropylene. The middle layer is filter media composed of 100% white melt-blown polypropylene. The inner (patient contacting) layer is made of either 100% white spun-bond polypropylene or 100% white medical grade tissue paper.
The ear attachments are either Ear Loop style. Ear Loops are made of elastic and the Tie-On straps are made of 100% white spun-bond polypropylene.
The nosepiece is made of malleable aluminum.
All materials used in the construction of the mask are being used in currently marketed devices.
Here's a breakdown of the acceptance criteria and study information for the Cross Protection ResQ300 Plus Surgical Face Mask, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Result) | Met Criteria? |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5): 0 – None, 1 – Slight, 2 – Mild | Not cytotoxic – Mild reactivity | Yes |
| Primary Skin Irritation (ISO 10993-10): Negligible: 0 to 0.4 | Negligible irritant | Yes |
| Sensitization (ISO 10993-10): 0 – No visible change | Non-sensitizing | Yes |
| Performance Testing (ASTM F2100 Level 1): | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19): ≥ 95% | Level 1 | Yes (≥ 95%) |
| Differential Pressure (Delta P) (EN14683): |
§ 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.