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510(k) Data Aggregation
(216 days)
The disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The disposable medical face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask, seeking to demonstrate substantial equivalence to a predicate device. It addresses the physical and filtration performance of the mask, rather than the performance of an AI/ML-driven medical device. Therefore, many of the requested criteria relating to AI/ML device performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, and human-in-the-loop performance, are not applicable to this document.
However, I can extract and present the information available regarding the acceptance criteria and the study that proves the device meets those criteria for this medical face mask.
Device: Disposable Medical Face Mask (Model TP-001)
Product Code: FXX
Regulation Number: 21 CFR 878.4040
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The device model TP-001 is stated to meet both Level 2 and Level 3 performance requirements in ASTM F2100. The table below combines the acceptance criteria and the observed performance for both levels as presented in the document.
| Test Item (Performance Level 2/Level 3) | Acceptance Criteria (Level 2) | Acceptance Criteria (Level 3) | Reported Device Performance (Model TP-001 - across 3 lots) | Verdict |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | BFE ≥ 98% | BFE ≥ 98% | Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9% | Pass |
| Differential Pressure (Delta-P) (EN 14683:2019, Annex C) | Delta-P |
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