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The AOK 95A Medical Mask (20200049) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use 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 AOK 95A Medical Mask (20200049) is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The AOK 95A Medical Mask will be provided in white and blue. The AOK 95A Medical Mask is sold non-sterile and are intended to be single use, disposable devices.

This document describes the safety and effectiveness of the AOK 95A Medical Mask (K220876) by comparing it to a legally marketed predicate device (AOK Tooling Limited - K211956). The evaluation relies on non-clinical performance testing.

1. Acceptance Criteria and Reported Device Performance

The table below summarizes the acceptance criteria and the reported performance of the AOK 95A Medical Mask. These criteria are based on ASTM 2100 Level 2 standards.

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The 039 Medical Surgical 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 face masks are intended for use 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 039 Medical Surgical Face Mask is single use, four- layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in blue. The 039 Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.

This document describes the regulatory submission for the "039 Medical Surgical Face Mask," a Class II medical device, seeking clearance under a 510(k) premarket notification. The purpose of the submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605).

The core of the submission relies on non-clinical performance testing to meet established acceptance criteria, which are primarily based on ASTM F2100-2019 standards for medical face masks.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: For the non-clinical performance testing (BFE, Differential Pressure, PFE, Synthetic Blood Penetration, Flammability), three separate non-consecutive lots of 32 samples each were tested. This means a total of 96 samples were tested for each performance criterion.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is a premarket notification for a new device, the testing would inherently be prospective and conducted specifically to support the submission. The manufacturer, AOK Tooling Limited, is located in Shen Zhen, China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This submission pertains to the performance characteristics of a physical medical device (face mask). The "ground truth" for these tests is established by standardized laboratory testing methodologies (e.g., ASTM and EN standards) and the physical measurements and observations derived from these tests.
• Therefore, the concept of "experts" establishing ground truth in the sense of human interpretation of medical images or diagnoses (as would be relevant for an AI/CAD device) is not directly applicable here. The experts involved would be the laboratory technicians and engineers who conduct these standardized tests, ensuring adherence to the test protocols and accurate data collection. Their qualifications would typically include training in laboratory procedures, relevant instrumentation, and quality control. The document does not specify the number or specific qualifications of these laboratory personnel.

4. Adjudication Method for the Test Set:

• The testing involves objective measurements and observations based on standardized protocols, not subjective human interpretation requiring adjudication. For example, bacterial filtration efficiency is a measured percentage, and synthetic blood penetration is a visual inspection for the presence of fluid.
• Therefore, an "adjudication method" in the context of resolving discrepancies in expert opinions (like 2+1 or 3+1 for medical image interpretations) is not applicable to this type of device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in tasks like image interpretation. This submission is for a physical medical device (face mask) that does not involve human readers interpreting data assisted by AI.
• The study focuses on the physical and performance characteristics of the mask itself, demonstrating its standalone efficacy in barrier protection, breathability, etc., against predefined objective criteria.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a form of standalone performance evaluation was done. The described non-clinical testing assesses the intrinsic performance of the medical face mask (the device itself) against objective physical and performance standards. It measures properties like filtration efficiency, breathability, fluid resistance, and flammability. These tests evaluate the device's technical specifications and capabilities without human intervention or interpretation of diagnostic output.

7. The Type of Ground Truth Used:

• The ground truth used for evaluating the device's performance is based on standardized, objective physical and material performance measurements as defined by:
  • ASTM (American Society for Testing and Materials) standards: Specifically, ASTM F2100-2019 (Standard Specification for Performance of Materials Used in Medical Face Masks), ASTM F2101 (Bacterial Filtration Efficiency), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), and ASTM F1862/F1862M-2017 (Resistance to Penetration by Synthetic Blood).
  • EN (European Norm) standard: EN14683:2019+AC:2019 Annex C (Differential Pressure).
  • CFR (Code of Federal Regulations): 16CFR Part 1610-2008 (Flame spread).
• These standards specify the methodology and expected outcomes for each test, providing the objective "ground truth" for the device's performance.

8. The Sample Size for the Training Set:

• This is a submission for a physical medical device (face mask). The concept of a "training set" is typically associated with machine learning or AI models, where data is used to train an algorithm.
• Since this is not an AI/ML device, there is no training set in the conventional sense. The device's design and manufacturing processes are informed by engineering principles and material science, rather than data-driven training.

9. How the Ground Truth for the Training Set Was Established:

• As there is no training set for this type of device, this question is not applicable.

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The Plain Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 Plain Surgical Face Mask is a single use, three-layer, flat-folded masks with ear loops and adjustable clips and nose piece. The Plain Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask and with adjustable clips. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes the acceptance criteria and the results of a study conducted for the AOK Tooling Limited's "Plain Surgical Face Mask" (K201517) to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

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