(30 days)
The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile.
The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly 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. The surgical masks are single use, disposable devices, provided non-sterile.
The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose.
The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.
This document describes the performance of a medical device, specifically Procedure Masks with Ear Loops and Surgical Masks with Ties, submitted for FDA 510(k) clearance (K221134). The device is compared to a predicate device (K202899) to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on ASTM F2100-19 for medical face mask performance, and other relevant standards like ASTM F1862/F1862M-17 (Fluid Resistance), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 + AC:2019 Annex C (Differential Pressure), 16 CFR 1610 (Flammability), ISO 10993-5: 2009 (Cytotoxicity), and ISO 10993-10: 2010 (Irritation and Sensitization).
There are two tables provided in the document:
- Table 1: Comparison of Performance Testing for Proposed ASTM Level 1 Procedure Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate Device
- Table 2: Comparison of Performance Testing for Proposed ASTM Level 3 Procedure Mask with Ear Loops (PM3003) and Surgical Mask with Ties (SM3003) with Predicate Device
Table 1: ASTM Level 1 Masks (PM3001 & SM3001)
| Non-Clinical Test | Acceptance Criteria (ASTM Level 1) | Proposed Device Performance (PM3001) | Proposed Device Performance (SM3001) |
|---|---|---|---|
| Fluid Resistance | ≥ 29 of 32 pass at 80 mmHg | Pass (96/96) at 80 mmHg, 32 samples from 3 non-consecutive lots | Pass (96/96) at 80 mmHg, 32 samples from 3 non-consecutive lots |
| Particulate Filtration Efficiency | ≥ 95% at 0.1 micron | Pass (96/96) at > 95%, 32 samples from 3 non-consecutive lots | Pass (96/96) at > 95%, 32 samples from 3 non-consecutive lots |
| Bacterial Filtration Efficiency | ≥ 95% | Pass (96/96) at > 95%, 32 samples from 3 non-consecutive lots | Pass (96/96) at > 95%, 32 samples from 3 non-consecutive lots |
| Differential Pressure | 98%, 32 samples from 3 non-consecutive lots | Pass (95/96) at > 98%, 32 samples from 3 non-consecutive lots | |
| Bacterial Filtration Efficiency | ≥ 98% | Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots | Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots |
| 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.