(307 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
This document describes the acceptance criteria and performance data for Mexpo International Inc.'s Non Sterile Nitrile Powder Free Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria are based on the ASTM D6319 and ASTM D6124 standards for nitrile examination gloves.
| Characteristic | ASTM D6319/D6124 Requirement | Reported Device Performance (Table 3, for Blue, Green, and Black Gloves) |
|---|---|---|
| DIMENSIONS | ||
| Overall Length | Small: Pass (237-253 mm) | |
| Medium: Pass (240-251 mm) | ||
| Large: Pass (240-255 mm) | ||
| X-Large: Pass (241-277 mm) | ||
| - Small | 220 mm minimum | Pass |
| - Medium | 230 mm minimum | Pass |
| - Large | 230 mm minimum | Pass |
| - X-large | 230 mm minimum | Pass |
| Width | Small: Pass (85-88 mm) | |
| Medium: Pass (95-98 mm) | ||
| Large: Pass (105-109 mm) | ||
| X-Large: Pass (113-116 mm) | ||
| - Small | $80 \pm 10$ mm | Pass |
| - Medium | $95 \pm 10$ mm | Pass |
| - Large | $110 \pm 10$ mm | Pass |
| - X-large | $120 \pm 10$ mm | Pass |
| Palm Thickness | 0.05 mm minimum | Small: Pass (0.06-0.14 mm) |
| Medium: Pass (0.06-0.13 mm) | ||
| Large: Pass (0.05-0.13 mm) | ||
| X-Large: Pass (0.06-0.13 mm) | ||
| Finger Thickness | 0.05 mm minimum | Small: Pass (0.09-0.17 mm) |
| Medium: Pass (0.09-0.18 mm) | ||
| Large: Pass (0.10-0.16 mm) | ||
| X-Large: Pass (0.10-0.16 mm) | ||
| PHYSICAL PROPERTIES | ||
| Tensile Strength (Before Aging) | 14 MPa minimum | Small: Pass (24.1-41.2 MPa) |
| Medium: Pass (25.9-46.5 MPa) | ||
| Large: Pass (21.2-42.2 MPa) | ||
| X-Large: Pass (19.6-43.5 MPa) | ||
| Tensile Strength (After Aging) | 14 MPa minimum | Small: Pass (24.4-43.5 MPa) |
| Medium: Pass (24.8-45.8 MPa) | ||
| Large: Pass (20.7-43.0 MPa) | ||
| X-Large: Pass (21.6-44.8 MPa) | ||
| Ultimate Elongation (Before Aging) | 500% minimum | Small: Pass (500-600%) |
| Medium: Pass (500-600%) | ||
| Large: Pass (500-600%) | ||
| X-Large: Pass (460-560%) Note: X-Large Black glove reports 460-540%, which includes values below 500% (e.g., 460%). This is a slight discrepancy against the "500% minimum" requirement, though generally reported as "Pass". | ||
| Ultimate Elongation (After Aging) | 400% minimum | Small: Pass (460-580%) |
| Medium: Pass (460-600%) | ||
| Large: Pass (480-560%) | ||
| X-Large: Pass (440-560%) | ||
| FREEDOM FROM HOLES (Pinhole Inspection) | AQL=2.5 | Small: Pass (Found=0-2) |
| Medium: Pass (Found=0) | ||
| Large: Pass (Found=0-1) | ||
| X-Large: Pass (Found=1-6) | ||
| Inspection Level | G-1 | Pass |
| POWDER FREE/Powder Content | Does not exceed 2 mg/glove | Small: Pass (Average: 0.04-0.36 mg/glove) |
| Medium: Pass (Average: 0.06-0.70 mg/glove) | ||
| Large: Pass (Average: 0.04-0.30 mg/glove) | ||
| X-Large: Pass (Average: 0.10-1.02 mg/glove) | ||
| BIOCOMPATIBILITY | ISO 10993-10, ISO 10993-11 | Non-irritant, non-sensitizer, no acute systemic toxic effects. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the total sample size across all tests for the subject device. However, for the "Freedom from Holes (Pinhole Inspection)" test, the sample size per size/color variation is reported as n=200 gloves (as indicated by "Accept on 10 (n=200)" or "Accept on 7 (n=200)"). The specific number of gloves tested for other physical and dimensional properties is not detailed, but it is implied that sufficient samples were tested to demonstrate compliance with ASTM standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It presents the results as "Summary of Device Specifications and Performance Results" and "Performance Test Results Comparison," implying the data was generated from testing of the subject gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this type of device (nitrile examination gloves). The "ground truth" for glove performance is established by objective, standardized laboratory tests according to recognized industry standards (ASTM D6319, ASTM D6124, ISO 10993 series for biocompatibility), not by expert consensus in the way medical imaging or diagnostic devices might require.
4. Adjudication Method for the Test Set:
This information is not applicable. As standard laboratory tests are used, there is no subjective interpretation requiring an adjudication method. The results are quantitative measurements or pass/fail criteria against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device on human expert performance, which is not relevant for examination gloves.
6. If a Standalone Performance Study Was Done:
Yes, a standalone (algorithm only, without human-in-the-loop performance) study was done. The document presents the performance of the device itself against recognized objective standards without requiring human interaction or interpretation beyond performing the tests. The results in Table 3 directly reflect the intrinsic properties of the gloves.
7. The Type of Ground Truth Used:
The ground truth used is based on established industry standards and objective physical/chemical measurements. Specifically:
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-06 (2011): Standard Test Method for Detection of Holes in Medical Gloves
- ISO 10993-10: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11: Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
These standards define the acceptable ranges and methodologies for determining the "truth" of a glove's dimensions, physical properties, freedom from holes, and biocompatibility.
8. The Sample Size for the Training Set:
This information is not applicable. Examination gloves do not typically involve a "training set" in the context of machine learning or AI. The manufacturing process is controlled to consistently produce gloves meeting specifications.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8. The "ground truth" for quality control and manufacturing is the continuous adherence to the established product specifications and the ASTM/ISO standards.
§ 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.