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The Medical Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: S,M,L,XL. The subject device is non-sterile.

The provided text describes the 510(k) summary for the "Medical Nitrile Examination Gloves" (K220066). This document is for a Class I medical device (non-powdered patient examination glove), which is a low-risk device. For such devices, clinical testing is typically not required, and the focus of the submission is on non-clinical performance and substantial equivalence to a predicate device.

Therefore, the requested information regarding AI device performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this specific submission. This document details the testing of physical properties and biocompatibility of examination gloves, not an AI or imaging device.

However, I can extract the acceptance criteria and performance data for the glove product based on the provided non-clinical testing summary.

Here's the relevant information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, for Medical Nitrile Examination Gloves)

Points 2-9 are not applicable to this submission as it is not for an AI / imaging device.

Regarding the "study that proves the device meets the acceptance criteria," the "Summary of Non-clinical Testing" (Section 8.0) and "Table 2 - Summary of non-clinical performance testing" provide the evidence.

• Sample sizes used for the test set and data provenance:

  • For the Watertightness Test (ASTM D5151), the result "0/125/Pass" implies a sample size of 125 gloves were tested.
  • Other tests (e.g., physical dimensions, strength, thickness, powder content, biocompatibility) would have specific sample sizes per the ASTM/ISO standards, but these are not explicitly stated in the summary table beyond the result itself (e.g., "S: 83-88 /Pass").
  • Data provenance: Not explicitly stated, but typically non-clinical testing for medical devices is performed by accredited labs, often in the country of manufacture (China, in this case, as per the submitter's address). This is retrospective for the purpose of the submission.

• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. These are laboratory tests measuring physical and chemical properties, not human interpretation of images or clinical outcomes.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.

• The type of ground truth used:

  • For physical/chemical tests: The "ground truth" is defined by the technical specifications and methodologies outlined in the referenced ASTM and ISO standards (e.g., specific measurement techniques, chemical analyses, biological assays).
  • For biocompatibility tests: The "ground truth" is based on the biological responses observed in the in vitro and in vivo models as per ISO 10993 standards.

• The sample size for the training set: Not applicable (this is not an AI/ML device).

• How the ground truth for the training set was established: Not applicable.

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Medical Surgical 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. This is a single use, disposable device(s), provided as sterile.

The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of 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. The elastic ear loops are not made with natural rubber latex. The nose piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "Medical Surgical Mask" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the total sample size for the entire test set in a singular number. However, it indicates the sample size for specific tests per lot:

• Fluid Resistance: 32 samples per lot (tested against 3 lots).
• Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: The results are presented for 3 distinct 'Lots' (Lot 1, Lot 2, Lot 3). While the exact number of samples per lot for these tests isn't always explicitly stated (except for fluid resistance), the presentation implies multiple measurements per lot.
• Biocompatibility: The sample size for biocompatibility tests (cytotoxicity, irritation, sensitization) is not specified.

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD is located in China, it's highly probable the testing was conducted there.

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

This information is not applicable and not provided in the document. The tests performed are objective, quantitative laboratory measurements (e.g., filtration efficiency, fluid resistance) based on established ASTM and military standards, not subjective assessments requiring expert consensus on a "ground truth" (like image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the tests are objective laboratory measurements, not subjective assessments requiring an adjudication method among experts.

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

There was no MRMC comparative effectiveness study and no AI component mentioned. This document describes the performance testing of a physical medical device (a surgical mask), not an AI-powered diagnostic tool. Therefore, effects on human reader performance with or without AI assistance are not relevant.

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

There was no standalone (algorithm only) performance study done, as this product is a physical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests directly stems from standardized laboratory test results against predefined acceptance criteria. For example:

• For filtration efficiency, the ground truth is the measured percentage of particles/bacteria filtered.
• For fluid resistance, the ground truth is whether the sample passed or failed at a specific pressure.
• For biocompatibility, the ground truth is the biological response observed in the in vitro or in vivo tests.

This is based on objective measurements and established scientific methods, not expert consensus, pathology, or outcomes data in the traditional sense of clinical studies.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of testing a physical medical device like a surgical mask, as there is no algorithm or model being trained.

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

This information is not applicable and not provided, as there is no training set for this type of device submission.

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