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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

The provided text describes the regulatory submission for the "Ever Light Plastic Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of, for example, an AI/ML medical device, is largely not applicable to this submission. The device is a patient examination glove, and its evaluation relies on established standards for physical properties and biocompatibility, not on AI-driven performance metrics.

Below, I've addressed the relevant sections based on the available information and indicated where the requested details are not applicable.

Table of Acceptance Criteria and Reported Device Performance

Additional Requested Information:

This section will address the remaining points, noting their applicability to a medical glove submission.

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

   • Sample Size:
     • For Physical & Dimensions testing: "Inspection level S-2, AQL 4.0." (ASTM D-5250-00E4)
     • For Water Fill Test: "samplings of AQL 2.5, inspection level I."
     • For Primary Skin Irritation and Skin Sensitization: Not specified, but implied to be sufficient for a "no primary skin irritant or sensitization reactions" conclusion.
     • For Residual Powder Test: Not specified, but implied to be sufficient to "insure that our gloves meet our 'powder-free' claims."
   • Data Provenance: Not explicitly stated beyond the tests being conducted for the submitter, Ever Light Plastic Products Co., Ltd., which is based in Hebei, China. The tests are assumed to be prospective, carried out on samples from the manufacturing process.

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)

   • Not Applicable. For medical gloves, "ground truth" is established by adherence to recognized industrial standards (ASTM) and regulatory requirements (FDA water fill test, biocompatibility). These criteria are objective measurements, not subjective interpretations by medical experts in fields like radiology.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image review by radiologists). For the objective tests performed on gloves (e.g., tensile strength, dimensions, pinhole detection, chemical residue), no such adjudication is necessary. The results are quantitative and directly compared against the specified limits in the standards.

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 device is a patient examination glove and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

   • Not Applicable. This device is a physical medical product (gloves), not an algorithm or AI system.

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

   • The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards (e.g., ASTM D-5250-00E4 for physical properties, ASTM D-6124-01 for residual powder, FDA's water fill test for barrier integrity, and biocompatibility testing for skin irritation/sensitization). There is no "expert consensus" or "pathology" in the sense of diagnostic interpretation for a glove.

8. The sample size for the training set

   • Not Applicable. This device is a physical product, not a machine learning model; therefore, there is no "training set."

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

   • Not Applicable. As there is no training set for a physical device like a glove, this question is not relevant.

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