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The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's 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 mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device. This product contains no components made from natural rubber latex.

This document is a 510(k) premarket notification for a medical device: a Disposable Medical Mask (K212826). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a set of acceptance criteria through a clinical study that uses AI or human readers for diagnosis. Therefore, several aspects of your request (related to AI, human readers, ground truth establishment for a training set, the number of experts, and adjudication methods for a test set) are not applicable to the content provided.

However, I can extract the acceptance criteria and performance data for the physical properties and biocompatibility of the medical mask, as these are the "device performance" aspects evaluated in this submission for regulatory clearance.

Here's a breakdown of the requested information based on the provided document:

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

The document presents performance criteria for the Disposable Medical Mask based on established ASTM and EN standards for medical face masks.

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Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):

The following drugs had NO breakthrough detected up to 240 minutes:

Busulfan, 6 mg/ml (6,000 ppm)
Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm)
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm)
Cytarabine HCI, 100 mg/ml (100,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Docetaxel, 10 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Ifosfamide, 50 mg/ml (50,000 ppm)
Mechlorethamine HCI, 1 mg/ml (1,000 ppm)
Methotrexate, 25 mg/ml (25,000 ppm)
Mitomycin, 0.5 mg/ml (500 ppm)
Mitoxantrone, 2 mg/ml (2,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Vincristine Sulfate, 1 mg/ml (1,000 ppm)

Please note that the following drug has low permeation times of less than 60 minutes:

Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes

ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes

WARNING: Do not use Carmustine and Thiotepa

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

This document describes the acceptance criteria and performance of "Disposable Medical Nitrile Examination Gloves (Non sterile)" (K212639).

This medical device is a Class I device and does not involve AI or human interpretation of medical images. Therefore, many of the requested categories in the prompt are not applicable. The information provided is based on the provided FDA 510(k) summary, which focuses on physical, chemical, and biological testing as per relevant ASTM and ISO standards for examination gloves.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each physical and chemical test (e.g., number of gloves tested for dimensions, holes, etc.). The testing was conducted according to established ASTM and ISO standards, which typically specify the required sample sizes for each test.

The data provenance is from Jiangsu Nanfang Medical Co., Ltd in China. The tests were non-clinical, laboratory-based performance tests, not involving human subjects or patient data, so the terms "retrospective" or "prospective" are not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for this device is based on objective, quantifiable physical, chemical, and biological measurements performed according to standardized testing protocols (e.g., ASTM, ISO). There is no "expert" interpretation or "ground truth" establishment in the sense of clinical image analysis or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the testing involves objective laboratory measurements, not subjective evaluations or interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This device is a disposable medical glove and does not involve AI or human readers for diagnostic purposes.

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

This is not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device is based on objective measurements obtained through standardized physical, chemical, and biological testing methods (ASTM and ISO standards). Examples include:

• Precise measurements of dimensions (width, length, thickness).
• Quantifiable tensile strength and elongation.
• Measured breakthrough times for chemotherapy drugs.
• Results from established biocompatibility tests (skin irritation, sensitization, cytotoxicity) with clear pass/fail criteria.

8. The sample size for the training set

This is not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

This is not applicable.

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