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A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove:

The provided document is a 510(k) Summary for a medical device: 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

The "study" in this context refers to the testing performed against recognized standards and comparative data with predicate devices to demonstrate the new device is as safe and effective as existing ones.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from ASTM D3578-05 (Standard Specification for Rubber Examination Gloves) and in comparison to predicate devices.

Note on "Minor difference": The document explicitly labels the Tensile Strength after aging as having a "Minor difference" compared to one predicate, indicating that while the measurement itself meets the minimum, the specific value is divergent from one of the predicate devices. However, it still meets the stated "Min 14 Mpa" acceptance criteria. The thickness and elongation values also show variation from predicates but generally meet the stated minimums.

Study Details:

This submission describes non-clinical performance testing and a comparison to predicate devices to establish substantial equivalence. It does not involve a multi-reader, multi-case study with human readers or an AI algorithm.

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

• Test Set Sample Size: Not explicitly stated as a single "test set" in the context of clinical trials or AI evaluation. The testing performed involves samples of gloves taken from manufacturing lots. For example, for physical specifications and dimensions testing, the inspection level is S-2 with an AQL 4.0, and for pinholes, an AQL of 2.5 is used. These AQLs (Acceptance Quality Limit) specify the maximum percentage of defective units in a lot that can be considered acceptable.
• Data Provenance: The data originates from internal testing conducted by the manufacturer, Koon Seng Sdn. Bhd., in Malaysia to demonstrate compliance with ASTM D3578-05a and other standards (biocompatibility). It is retrospective in the sense that these are manufacturing quality control tests, not a prospective clinical study specifically designed for this submission.

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

• Not Applicable. For a medical examination glove, "ground truth" typically relates to objective measurements performed by laboratory technicians or validated testing equipment against established standards (e.g., ASTM standards for glove properties, ISO standards for biocompatibility). There are no "experts" in the sense of clinical specialists establishing a "ground truth" for interpretation, as would be the case for diagnostic imaging.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used in studies where there's subjective interpretation by multiple human readers (e.g., radiologists) and a need to resolve discrepancies. The testing for this glove involves objective, quantitative measurements and pass/fail criteria based on standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is not relevant for a patient examination glove. An MRMC study would typically be used to assess the impact of an AI algorithm on human reader performance (e.g., in medical image interpretation).

6. Standalone (Algorithm Only) Performance Study:

• No. This device is a physical product (a glove), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• The "ground truth" for this device is based on objective, quantitative measurements against recognized industry standards (ASTM D3578-05a) and biocompatibility testing performed according to international standards. For example:
  • Physical dimensions: Measured length, width, thickness.
  • Physical properties: Measured tensile strength and elongation.
  • Biocompatibility: Results from standardized tests for skin irritation and dermal sensitization.
  • Defect levels: Based on accepted quality limits (AQL) which define the maximum allowable percentage of defects (e.g., pinholes).
  • Chemical residues: Quantitative measurement of powder and protein content.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable. (See point 8).

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