(102 days)
The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
The provided document describes the acceptance criteria and performance data for "PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)".
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D 3577-91) | Reported Device Performance (PROFEEL Powder Free Surgical Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on AQL of 1.0 (indicating better performance than required) |
| 2. Length (mm) | ||
| Size 5½ | min 245 | 277 |
| Size 6 | min 265 | 282 |
| Size 6½ | min 265 | 281 |
| Size 7 | min 265 | 299 |
| Size 7½ | min 265 | 298 |
| Size 8 | min 265 | 298 |
| Size 8½ | min 265 | 298 |
| Size 9 | min 265 | 299 |
| 3. Palm width (mm) | ||
| Size 5½ | 70 ± 6 | 72 |
| Size 6 | 76 ± 6 | 78 |
| Size 6½ | 83 ± 6 | 83 |
| Size 7 | 89 ± 6 | 90 |
| Size 7½ | 95 ± 6 | 95 |
| Size 8 | 102 ± 6 | 102 |
| Size 8½ | 108 ± 6 | 108 |
| Size 9 | 114 ± 6 | 114 |
| 4. Thickness (mm) | ||
| Finger | min 0.10 | 0.23 |
| Palm | min 0.10 | 0.20 |
| 5. Physical Properties | ||
| Before Aging: | ||
| Tensile Strength (MPa) | min 24 | 28.19 |
| Ultimate Elongation (%) | min 750 | 827 |
| After Aging: | ||
| Tensile Strength (MPa) | min 18 | 22.23 |
| Ultimate Elongation (%) | min 560 | 898 |
| 6. Powder Content | - (Not specified in ASTM D 3577-91) | below 2 mg / glove |
| 7. Protein Content | - (Not specified in ASTM D 3577-91) | below 50 microgram / gram |
The study concludes that the PROFEEL Powder Free Surgical Gloves exceed the ASTM D 3577-91 requirements, meet FDA pinhole requirements, and meet the protein content labeling claim.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for each individual test. It refers to "Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test," which are established standards that would define sample sizes for testing. For example, "S-4, AQL 1.5" for the watertight test refers to a sampling plan from an acceptance sampling standard (often MIL-STD-105E or equivalent) which would specify sample sizes based on lot size and AQL.
The data provenance is from Malaysia, as the manufacturer, Wembley Rubber Products (M) Sdn. Bhd., is located in Sepang, Selangor Darul Ehean, Malaysia. The data is non-clinical performance data, likely generated through laboratory testing of the gloves, not from human subject studies. Therefore, it is retrospective in the sense that the tests were performed on manufactured products, rather than prospectively collected clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for the performance of surgical gloves is established by objective measurements against industry standards (ASTM D 3577-91 and FDA watertight test for pinholes), not by expert consensus or interpretation of subjective data. The tests are designed to quantitatively measure physical properties.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective, quantitative measurements against predefined standards, 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
This is not applicable. This document describes the performance of a physical medical device (surgical gloves), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no algorithm or AI component to this medical device.
7. The Type of Ground Truth Used
The ground truth used is objective quantitative measurements against established industry standards (ASTM D 3577-91 for physical properties, and FDA 1000 ml watertight test for freedom from pinholes). For powder and protein content, specific laboratory tests (e.g., ASTM D5712 for protein content) are used to provide quantitative "ground truth" values.
8. The Sample Size for the Training Set
This is not applicable. This refers to a manufactured physical product. There is no machine learning model involved that would require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above; there is no training set for a physical product like surgical gloves.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).