(25 days)
The Freudenberg Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. 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.
The Freudenberg Surgical Mask is composed of three-layers and is flat-pleated. The Freudenberg Surgical Mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), and inner cover web (polypropylene spunbond, white). Each mask contains polyester spandex blend ear loops to secure the mask over the user's mouth and nose and includes a polyethylene coated wire nosepiece to provide a firm fit over the nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
This document is a 510(k) Premarket Notification for a Freudenberg Surgical Mask, not an AI/ML medical device. Therefore, the information requested about acceptance criteria and study data for an AI/ML device is not present in this document. This document pertains to the physical and performance characteristics of a surgical mask, compared to a predicate surgical mask.
However, I can extract the acceptance criteria and performance data for the surgical mask as presented in the document.
Here's the information about the surgical mask:
1. A table of acceptance criteria and the reported device performance
The document compares the "Proposed Device (K210063) Freudenberg Surgical Mask" to a "Predicate Device (K182514) SURGICAL FACE MASK" based on several performance metrics. The acceptance criteria for the proposed device are implicitly defined by meeting or exceeding the performance of the predicate device and conforming to relevant ASTM/EN standards, particularly for Level 3 categorization.
| Performance Metric | Acceptance Criteria (ASTM/EN Standard or Predicate Performance) | Reported Device Performance (Freudenberg Surgical Mask - K210063) |
|---|---|---|
| Fluid Resistance | Predicate: 32/32 passed at 120 mmHg - ASTM F1862. Goal: Exceed predicate/meet Level 3 (160 mmHg, AQL 4.0). | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg - ASTM F1862. |
| Lot 698002: 31/32 passed | ||
| Lot 697715: 32/32 passed | ||
| Lot 697944: 31/32 passed | ||
| (Comment: "Similar, subject device exceeded fluid resistance of predicate device") | ||
| Bacterial Filtration Efficiency (BFE) | Predicate: pass at 99.6% - ASTM F2101. Goal: ≥98% (for Level 3 per ASTM F2100-19) | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2101. |
| Lot 698002: 32/32 passed at 99.9% | ||
| Lot 697715: 32/32 passed at 99.9% | ||
| Lot 697944: 32/32 passed at 99.9% | ||
| (Comment: "Similar, both devices meet ASTM F2101") | ||
| Particulate Filtration Efficiency (PFE) | Predicate: pass at 99.88% - ASTM F2299. Goal: ≥98% (for Level 3 per ASTM F2100-19) | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2299. |
| Lot 698002: 32/32 passed at 99.6±0.1% | ||
| Lot 697715: 32/32 passed at 99.5±0.1% | ||
| Lot 697944: 32/32 passed at 99.7±0.1% | ||
| (Comment: "Similar, both devices meet ASTM F2299") | ||
| Differential Pressure (Delta P) | Predicate: pass at 3.0 mmH₂O/cm² - MIL-M036954C. Goal: |
§ 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.