(47 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a8 and FDA Water leak test.
The provided document describes the acceptance criteria and performance of "MULTIPLE PRIVATE LABELS, NON-STERILE, POWDER-FREE POLYURETHANE, WHITE COLOR EXAMINATION GLOVES" by YTY Industry (Manjung) Sdn Bhd.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM D6319-00a) | Reported Device Performance (Powder Free Polyurethane Exam Gloves) |
|---|---|---|
| Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| Length (mm) | XS: Min 220 | 240 mm minimum for all sizes |
| S: Min 220 | ||
| M: Min 230 | ||
| L: Min 230 | ||
| XL: - | ||
| Palm width (mm) | XS: 70 ± 10 | 73-78 |
| S: 80 ± 10 | 83 - 88 | |
| M: 95 ± 10 | 93-98 | |
| L: 110 ± 10 | 103 - 107 | |
| XL: - | ||
| Thickness (mm) (Single Layer) | Finger: Min 0.05 | Finger: Min 0.13 |
| Palm: Min 0.05 | Palm: Min 0.11 | |
| Physical Properties Before Aging | Tensile Strength (MPa): Min 14 | Tensile Strength (MPa): 16-23 |
| Ultimate Elongation (%): Min 500 | Ultimate Elongation (%): 600-800 | |
| Physical Properties After Aging | Tensile Strength (MPa): Min 14 | Tensile Strength (MPa): 20 - 23 |
| Ultimate Elongation (%): Min 400 | Ultimate Elongation (%): 600-720 | |
| Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
| Bio-compatibility Test | Pass Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test | The gloves pass the Bio-compatibility Test. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test. It refers to the ASTM D6319-00a standard and FDA 1000ML watertight test, which would define the sampling plans. The data provenance is from Malaysia, specifically YTY Industry (Manjung) Sdn Bhd. The study appears to be prospective for the device being submitted, as it's testing the performance of their gloves against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The acceptance criteria are based on the ASTM D6319-00a standard and FDA watertest, which are established industry and regulatory standards, not expert consensus for this specific study.
4. Adjudication Method for the Test Set:
This information is not provided. The assessment appears to be based on direct measurement and comparison against defined thresholds in the ASTM standard and FDA test, rather than an adjudication process between human reviewers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the physical and performance characteristics of a medical glove, not on the interpretation of medical images or data by human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical medical glove and not an algorithm or AI system. The performance tests are direct measurements of the glove's properties
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation is based on established industry standards and regulatory requirements. Specifically:
- ASTM D6319-00a: Standard Specification for Polyurethane Patient Examination Gloves.
- FDA 1000ML watertight test.
- Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization).
8. The Sample Size for the Training Set:
This question is not applicable. The device is a physical product (medical glove), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 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.