(58 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 patients' body, fluids, waste or environment.
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
This document describes the acceptance criteria and performance of the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue and Green).
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST | Acceptance Criteria (ASTM D3578-95) | Reported Device Performance (Cashmere Powder Free Nitrile Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| Length (mm) | ||
| Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| Palm width (mm) | ||
| Size XS | - | 75 - 78 |
| S | 80 +/- 10 | 82 - 88 |
| M | 95 +/- 10 | 92 - 98 |
| L | 111 +/- 10 | 102 - 108 |
| XL | - | 111 - 115 |
| Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| Physical Properties - Before Aging | ||
| Tensile Strength (Mpa) | Min 14 | 16.5 |
| Ultimate Elongation (%) | Min 500 | 550 |
| Physical Properties - After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 23.1 |
| Ultimate Elongation (%) | Min 500 | 520 |
| Powder Content | - (FDA Requirement) | Below 2 mg / glove |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test. However, the performance data is based on the ASTM D3578-95 standard and the FDA 1000 ml watertight test, which would typically specify sampling plans. The data provenance is from SEAL POLYMER INDUSTRIES SDN. BHD. in Lahat, Perak, Malaysia. The study appears to be a retrospective analysis of product performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For product performance testing against standard specifications like ASTM D3578-95, the "ground truth" is typically defined by the objective measurement procedures within the standard, not by expert consensus on individual cases.
4. Adjudication method for the test set:
Not applicable. The performance data is based on objective measurements and compliance with a standard (ASTM D3578-95) and FDA requirements, not on subjective interpretations requiring adjudication.
5. 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 a submission for a medical glove, a physical device, and not an AI-powered diagnostic or decision support tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
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 D3578-95 Standard for Rubber Examination Gloves.
- FDA 1000 ml watertight test for pinhole requirements.
- FDA requirements for minimum powder residual content.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device.
§ 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.