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The Disposable Medical 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 Disposable Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond 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 strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength greater than or equal to 100N; Elasticity greater than or equal to 2.8times; Breaking tension greater than 100N). The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.

This 510(k) premarket notification describes the non-clinical performance evaluation of Hubei Wanli Protective Products Co., Ltd.'s "Disposable Medical Mask" (K210150) to demonstrate its substantial equivalence to the predicate device, the Kimberly-Clark KC100 Mask (K110455).

1. Acceptance Criteria and Reported Device Performance:

   Item	Acceptance Criteria (Level 2)	Reported Device Performance (Lot2020120501, Lot2020120101, Lot2020120801)
   Synthetic Blood Performance (ASTM F1862)	29 out of 32 pass at 120 mmHg	32 out of 32 pass at 120 mmHg
   Particulate Filtration Efficiency (ASTM F2299)	≥ 98%	≥ 98%
   Bacterial Filtration Efficiency (ASTM F2101-19, EN 14683:2019 Annex B)	≥ 98%	≥ 98%
   Differential Pressure (Delta P) (ASTM F2100-19, EN 14683:2019 Annex C)	< 6.0 mmH₂O/cm²	< 6.0 mmH₂O/cm²
   Flammability (16 CFR 1610)	Class 1 (Burn time ≥ 3.5 seconds)	Class I
   Cytotoxicity (ISO 10993-5)	Non-Cytotoxic	No Cytotoxic
   Irritation (ISO 10993-10)	Non-Irritating	No irritating
   Sensitization (ISO 10993-10)	Non-Sensitizing	No Sensitizing

2. Sample size used for the test set and the data provenance:

   • Synthetic Blood Performance (ASTM F1862): 32 samples were tested for each of the three lots (Lot2020120501, Lot2020120101, Lot2020120801).
   • Other performance tests: The exact sample size for other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) is not explicitly stated as a number of discreet items, but results are provided for three distinct lots of the device.
   • Biocompatibility tests: Not explicitly stated how many samples were used for Cytotoxicity, Irritation, and Sensitization.
   • Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, but it's reasonable to infer they were specifically conducted for this submission (prospective) and likely conducted by or for the manufacturer in China, given the manufacturer's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this involves laboratory performance testing against established standards, not interpretation by human experts.

4. Adjudication method for the test set:

   • Not applicable as this involves objective laboratory measurements against set standards, not subjective expert judgment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is not applicable to a medical mask, which is evaluated based on physical performance characteristics rather than human interpretation of medical images or data.

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

   • Not applicable. This device is not an AI/algorithm-based diagnostic or assistive system. Its performance is intrinsic to its physical properties.

7. The type of ground truth used:

   • Objective performance standards: The "ground truth" for the performance tests consists of established, internationally recognized standards and test methods (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993). The device's performance is measured against the specified acceptance criteria defined within these standards.

8. The sample size for the training set:

   • Not applicable. This refers to training data for machine learning models, which is irrelevant for the evaluation of a medical mask.

9. How the ground truth for the training set was established:

   • Not applicable.

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