(50 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
This document describes the premarket notification (510(k)) for the Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powder Free. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be typical for more complex medical devices.
Therefore, many of the requested elements pertaining to clinical studies and associated metrics (like sample sizes for test sets, expert consensus, MRMC studies, training set details) are not applicable to this type of device and submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on meeting established industry standards and regulatory requirements for patient examination gloves.
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|
| Material Strength/Physical Properties (ASTM D5250-06) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves. Inspection level S-2, AQL 4.0." |
| Pinhole/Watertightness (FDA 1000 ml Watertight Test based on ASTM D-5151-06) | "conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements." |
| Biocompatibility (Primary Skin Irritation and Skin Sensitization) | "conducted with results showing no primary skin irritant or sensitization reactions." |
| Powder-Free Claim (ASTM D6124-06 for Starch) | "conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)" |
| Predicate Device Equivalence | "substantially equivalent to the device manufactured by Synmertex Company Limited (K032172)." |
| General Regulatory Compliance | "conform fully to ASTM D-5250-06 standard as well as applicable 21CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims." |
Study Details for Demonstrating Acceptance Criteria (Non-Clinical Tests)
The "study" described here is a series of non-clinical, laboratory-based tests.
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Sample size used for the test set and data provenance:
- ASTM D5250-06 (Physical and Dimensions): "Inspection level S-2, AQL 4.0." (Specific sample size not explicitly stated, but statistical sampling plan indicated).
- ASTM D-5151-06 (Watertightness): "samplings of AQL 2.5, Inspection level I" (Specific sample size not explicitly stated, but statistical sampling plan indicated).
- Biocompatibility (Skin irritation/sensitization): Sample size for this biological testing is not provided.
- ASTM D6124-06 (Residual Powder): Sample size for this testing is not provided.
- Data Provenance: The tests were performed by Rich Mountain Medical Products Inc. (manufacturer), presumably in China (country of origin for the submitter). These are retrospective tests conducted on samples of manufactured gloves.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests is defined by the objective pass/fail criteria of the ASTM standards and FDA requirements, which do not typically involve human expert adjudication in the same way as, for example, image interpretation.
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Adjudication method for the test set: Not applicable. Results are based on objective measurements and comparison to defined thresholds within the standards.
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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-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used: The ground truth is defined by the objective, quantitative measurements against established thresholds and specifications outlined in the referenced ASTM standards (D5250-06, D5151-06, D6124-06) and FDA requirements (e.g., biocompatibility criteria, pinhole limits, powder limits).
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The sample size for the training set: Not applicable. This device does not use an algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.