(76 days)
Medtexx Powder free Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
MEDTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 95, Standard Specification for Rubber Examination Gloves. They are natural white in color and are powder free.
Here's an analysis of the provided information regarding the MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES, focusing on acceptance criteria and supporting studies:
Assessment of the Provided Information:
The provided document describes a 510(k) premarket notification for a medical device: "MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES". This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.
It's crucial to understand that this document describes a physical medical device (gloves), not an AI/software as a medical device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of device.
The "acceptance criteria" here refers to the performance standards that the physical gloves must meet, primarily outlined in ASTM D 3578-95 and 21 CFR 800.20. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed on the gloves to demonstrate compliance with these standards.
Acceptance Criteria and Device Performance for MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical Properties (ASTM D 3578-95, Standard Specification for Rubber Examination Gloves) | |
| Not explicitly detailed in the provided text, but states compliance with the standard | Gloves meet "all the current specifications listed under the ASTM Specification D 3578 - 95" |
| Freedom from Holes (21 CFR 800.20) | |
| Not explicitly detailed in the provided text, but states compliance with the regulation | Gloves meet "all the current specifications listed under... 21 CFR 800.20" |
| Biocompatibility - Primary skin irritation | No irritation |
| Biocompatibility - Delayed contact sensitization | No sensitization |
| Presence of Starch (USP iodine test) | Negative |
| Protein Content (for "Protein Label Claim") | 50 micrograms or less of total water extractable protein per gram |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated the exact number of gloves tested for each criterion. The document generally states "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20," which implies that the sample sizes specified by these standards were followed. ASTM D 3578 typically specifies sampling plans for lot acceptance.
- Data Provenance: The tests were conducted by Medtexx Industries (Thai) Company Limited, from Thailand. The data is based on retrospective testing of glove samples for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This device is a physical product (examination gloves), not an AI/SaMD. "Ground truth" in this context refers to objective scientific measurements and established standards (ASTM D 3578-95, 21 CFR 800.20, USP iodine test) rather than expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this is a physical product. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in AI/SaMD contexts, not for objective physical or chemical tests of gloves. The "adjudication" is essentially the comparison of test results against the predefined quantitative and qualitative criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, Not Applicable: MRMC studies are specific to evaluating the diagnostic performance of human readers, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a physical product like examination gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, Not Applicable: This concept applies to AI algorithms and their performance. The gloves themselves do not have an "algorithm" to be evaluated in a standalone manner.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of these gloves is based on:
- Established Industry Standards: Specifically, ASTM D 3578-95 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20 (dealing with freedom from holes).
- Objective Laboratory Tests: For biocompatibility (primary skin irritation, delayed contact sensitization) and chemical analysis (USP iodine test for starch, measurement of water extractable protein).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for physical devices like these gloves. This concept is relevant for machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, there is no ground truth, in the context of AI/ML, to be established for it.
§ 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.