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The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

The document provided focuses on the substantial equivalence determination for PP CARE Nitrile Examination Gloves (K212629) based on non-clinical testing. It does not describe a clinical study or AI/algorithm performance. Therefore, many of the requested points are not applicable.

Here's the information that can be extracted from the provided text regarding the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Water Tightness Test: 200 samples were tested.
• Data Provenance: The tests described are non-clinical (laboratory/materials testing) and were performed by EG Group Product and Service Co., Ltd. in Thailand. The data is thus prospective for the purpose of this submission and originates from Thailand.
• For other tests like Dimensions, Physical Properties, Powder Residue, the sample sizes are not explicitly stated but are implied to be sufficient for demonstrating compliance with the respective ASTM standards.
• For biocompatibility tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity), specific animal models are mentioned (New Zealand White Rabbits, Guinea Pigs, Swiss Albino Mice), indicating laboratory testing.

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

• Not applicable. This document describes non-clinical performance and biocompatibility testing of medical gloves, not a study requiring expert clinical judgment for ground truth. The "ground truth" here is compliance with established international standards (ASTM, ISO, EN).

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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:

• Not applicable. This is not a study involving human readers or AI.

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

• Not applicable. This document is about medical gloves, not an algorithm or AI device.

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

• The "ground truth" for the device's performance against its acceptance criteria is defined by compliance with established international standards (ASTM D6319-19, EN 455-1:2000) and ISO 10993 series for biocompatibility. These standards set the benchmarks for physical properties, barrier integrity, and biological safety.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable. This is not an AI/machine learning study.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The device's compliance with acceptance criteria is demonstrated through a series of non-clinical tests performed in accordance with recognized international standards. These tests assessed:

• Dimensional properties: Length, width, and thickness as per ASTM D6319-19.
• Physical properties: Tensile strength and ultimate elongation (before and after aging) as per ASTM D6319-19.
• Powder Residue: Measurement of powder content as per ASTM D6319-19.
• Water Tightness: To detect holes, conducted in accordance with EN 455-1:2000.
• Biocompatibility:
  • Skin Irritation (ISO 10993-10:2010(E) using New Zealand White Rabbits)
  • Skin Sensitization (ISO 10993-10:2010(e) using Guinea Pigs)
  • In Vitro Cytotoxicity (ISO 10993-5:2009(E) by elution method)
  • Acute Systemic Toxicity (ISO 10993-11:2017 using Swiss Albino Mice)

The results show that the PP CARE Nitrile Examination Gloves meet or exceed all specified acceptance criteria derived from these standards for physical and barrier properties, and demonstrate acceptable biocompatibility (despite an "100% cytotoxic" in vitro result, which was mitigated by a successful acute systemic toxicity test, deeming the device non-toxic under study conditions). These non-clinical tests collectively provide the evidence that the device meets its performance requirements and is substantially equivalent to the predicate device.

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