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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM IN-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LtZ, and meets all requirement of ASTM Standard D5250-06 (2011).

This 510(k) submission is for Powder-Free Vinyl Patient Examination Gloves, which are Class I devices that typically do not require clinical studies. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM standards. Therefore, many of the typical AI/software-based study questions are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set Sample Size: For the FDA 1000 ml. Water Fill Test, the "samplings of AOL 2.5, Inspection Level I" were used. This indicates an acceptance quality limit (AQL) sampling plan, but the exact number of units sampled is not explicitly stated in the provided text. For Physical and Dimensions Testing, the "Inspection Level S-2, AOL 2.5" was used, again indicating a sampling plan rather than a fixed sample size. For Residual Powder testing, the standard ASTM D6124-06 was applied, but the specific sample size is not mentioned. For Biocompatibility testing, specific numbers of test subjects and samples are not provided but implied through "testing conducted".
   • Data Provenance: Not specified, but the manufacturing company is Zibo Tengyue Plastic Products Co., Ltd. from Zibo, Shandong, China. It is highly probable the testing was conducted in China or a contracted lab. The studies would be considered prospective for the specific batches tested.

2. 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. This device is a medical glove, and its performance is evaluated against engineering and biological standards, not by expert interpretation of images or clinical outcomes. Ground truth is established through standardized physical, chemical, and biological tests.

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

   • Not applicable. Performance is determined by objective measurements and compliance with ASTM standards and FDA tests.

4. 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 an AI/software device.

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

   • Not applicable. This is not an AI/software device. The tests performed are standalone in the sense that they evaluate the device itself without human interaction as part of the performance metric.

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

   • Standards-based Ground Truth: The ground truth for this device is based on established engineering and biological standards. This includes:
     • ASTM D5250-06 (2011): Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
     • ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
     • FDA 1000 ml. Water Fill Test: For pinhole detection.
     • Biocompatibility Standards: Implicitly for Primary Skin irritation and Skin Sensitization.

7. The sample size for the training set

   • Not applicable. There is no "training set" in the context of this device. Device performance is based on manufacturing processes and quality control testing, not machine learning.

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

   • Not applicable. As there is no training set, this question is irrelevant.

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