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The Surgical Masks are 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 Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. 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 clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

This document describes the non-clinical testing performed to demonstrate that the Allmed Medical Products Co., Ltd. Surgical Mask is substantially equivalent to a predicate device (K153496). The acceptance criteria and performance data are based on standard test methods for surgical masks.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The term "Similar" in the "Result" column implies that the proposed device met or exceeded the performance of the predicate device and the specified acceptance criteria.

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

• Fluid Resistance (ASTM F1862): 3 lots were tested, with each lot likely consisting of 32 samples (as the criteria specifies "29 out of 32 pass"). Data provenance is not explicitly stated but implied to be from laboratory testing performed by or for the manufacturer.
• Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN 14683 Annex C): The report indicates performance from multiple tests (e.g., three percentages for PFE/BFE, three pressure values for Delta P), suggesting at least 3 samples were tested for each.
• Flammability (16 CFR 1610): Sample size not specified, but typically involves a set number of specimens from the material.
• Biocompatibility (ISO 10993-5, -10): Sample sizes for "in vitro" and "in vivo" (for irritation/sensitization) tests are defined by the respective ISO standards, but not explicitly stated in this summary.

Data Provenance: The data appears to be from non-clinical laboratory testing (bench testing) of the device. The country of origin of the data is not explicitly stated, but the manufacturer is based in China. The testing is assumed to be prospective, performed specifically for this 510(k) submission.

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

Not applicable. This is a submission for a surgical mask focusing on physical and biological performance characteristics measured through standardized laboratory tests, not subjective expert evaluation of data like medical image analysis. The "ground truth" is established by the specifications of the test standards themselves (e.g., a specific percentage filtration efficiency, a defined pressure drop).

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions. The performance is objectively measured by established laboratory test methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is typically used for diagnostic devices that involve human interpretation of medical images or data. Surgical masks are medical devices with mechanical and biological filtration properties, evaluated through non-clinical bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The core of this submission relies on "standalone" performance testing of the device itself (the surgical mask) against established standards. There is no "human-in-the-loop" component in evaluating the fundamental performance characteristics of the mask (e.g., BFE, PFE, fluid resistance).

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by international and national consensus standards and regulatory guidelines (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993 series). These standards define the methodology and the acceptable performance thresholds for surgical masks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product (surgical mask) whose performance is evaluated through specified tests.

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

Not applicable, as there is no training set for this type of device.

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