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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 fingers to prevent contamination between patient and examiner.

A Powder-free Clear 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 Clear 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 D-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, LYZ, and meets all requirement of ASTM Standard 5250-06.

This document is a 510(k) Pre-market Notification for a medical device: Powder-free Clear Vinyl Patient Examination Gloves.

Here's an analysis of the acceptance criteria and study information provided, focusing on the requested elements:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds against which the device is formally judged. Instead, it presents a comparison of the proposed device's characteristics and performance against a legally marketed predicate device (K142703). The "Comparison Conclusion" column often states "Similar," implying that meeting or being comparable to the predicate's performance constitutes the acceptance for substantial equivalence.

Based on the "Technological Characteristic Comparison" table, here's a representation of the implicit acceptance criteria and the reported device performance:

"The Study That Proves the Device Meets the Acceptance Criteria":

The document describes non-clinical tests performed to demonstrate substantial equivalence to the predicate device. These tests align with recognized standards for patient examination gloves.

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

   • Length on Large Size: The specific sample size isn't explicitly stated for the "Average over 232.23mm" measurement.
   • Width of Palm on Large Size: The specific sample size isn't explicitly stated for the "Average 95mm" measurement.
   • Palm Thickness: The specific sample size isn't explicitly stated for the "Average 0.095 mm" measurement.
   • Fingertip Thickness: The specific sample size isn't explicitly stated for the "Average 0.09 mm" measurement.
   • Residual Powder: Not explicitly stated, but the testing was conducted per ASTM D6124-06.
   • Pinhole Results: The test set for pinhole detection was 125 gloves, with the requirement that fewer than two pieces of gloves out of 125 have pinholes to meet AQL 2.5. This seems to be a specific sample size.
   • Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The sample size for these studies is not specified in the provided summary.
   • Tensile Strength and Ultimate Elongation (Before and After Aging): The specific sample size used for these mechanical properties tests is not explicitly stated.
   • Water Fill Test: "Samplings of AOL 2.5, Inspection Level I" was used, but the specific number of gloves isn't given.
   • Data Provenance: The data appears to be prospective testing conducted on the Yongsheng Medical Products Co., Ltd gloves. The "country of origin" for these tests is implicitly China, as the submitter is based in China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an examination glove, and its performance is evaluated through objective physical, chemical, and biological tests governed by established standards (e.g., ASTM). There is no mention of human expert interpretation or subjective ground truth establishment for these types of tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not relevant for the objective performance tests of an examination glove.

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 document pertains to a physical medical device (examination gloves), not an AI imaging or diagnostic algorithm.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm. The tests are for the physical properties of the glove.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the performance characteristics of the gloves is established by the methods, specifications, and acceptable limits defined in the referenced industry standards, primarily ASTM D5250-06 for general requirements, ASTM D6124-06 for residual powder, and ASTM D5151-06 for pinhole defects. Biocompatibility tests followed standard protocols to determine irritation and sensitization.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

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

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