(86 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex.
The provided document describes the acceptance criteria and study results for Powder-Free Nitrile Examination Gloves.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Device Performance (Color: White, Blue, Black, Orange, Green) |
|---|---|---|
| Dimension (Length) | ASTM D6319-19 (XS: 220mm, S: 220mm, M: 230mm, L: 230mm, XL: 230mm, XXL: 230mm minimum) | All sizes and colors meet or exceed minimum length requirements (e.g., XS: 239-244mm, M: 230-245mm). |
| Dimension (Width) | ASTM D6319-19 (XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm) | All sizes and colors meet width requirements (e.g., XS: 75-77mm, M: 86-97mm). |
| Dimension (Finger Thickness) | ASTM D6319-19 (0.05mm minimum) | All sizes and colors meet or exceed minimum finger thickness (e.g., White: 0.07-0.10mm, Orange: 0.27-0.28mm). |
| Dimension (Palm Thickness) | ASTM D6319-19 (0.05mm minimum) | All sizes and colors meet or exceed minimum palm thickness (e.g., White: 0.05-0.06mm, Orange: 0.18-0.22mm). |
| Freedom from Holes | ASTM D6319-19, 21 CFR 800.20 (AQL 2.5) | Passed for all sizes and colors. |
| Physical Property (Tensile Strength Before Aging) | ASTM D6319-19 (14 MPa minimum) | All sizes and colors meet or exceed 14 MPa (e.g., White: 20.5-23.2 MPa). |
| Physical Property (Elongation Before Aging) | ASTM D6319-19 (500% minimum) | All sizes and colors meet or exceed 500% (e.g., White: 520-536%). |
| Physical Property (Tensile Strength After Aging) | ASTM D6319-19 (14 MPa minimum) | All sizes and colors meet or exceed 14 MPa (e.g., White: 20.2-26.8 MPa). |
| Physical Property (Elongation After Aging) | ASTM D6319-19 (400% minimum) | All sizes and colors meet or exceed 400% (e.g., White: 427-488%). |
| Residual Powder | ASTM D6319-19 (≤ 2.0 mg of residual powder per glove) | All sizes and colors meet this requirement (e.g., White: 0.74-0.98 mg). |
| Chemotherapy Drug Permeation (Breakthrough Detection Time) | >240 minutes for most drugs (except Carmustine and ThioTepa) | Performance is explicitly listed in Table 5.1 and Table 6.3. For example, Cisplatin: >240 minutes for all colors. Carmustine and ThioTepa have lower breakthrough times and are explicitly warned against. |
| Biocompatibility (Skin Irritation) | ISO 10993-10 (Non-irritant) | Non-irritant under the conditions of the study for all colors. |
| Biocompatibility (Skin Sensitization) | ISO 10993-10 (Non-sensitizer) | Non-sensitizer under the conditions of the study for all colors. |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 (Not acutely systemically toxic) | Not an acute systemic toxic under the condition of the study for all colors. |
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 (e.g., how many gloves were tested for dimensions, holes, or chemical permeation). It lists "Device Performance (Minimum)" in tables, implying that measurements were taken across a sample.
The data provenance is not explicitly mentioned (e.g., country of origin for the testing or if it was retrospective/prospective). However, the submitter's address is Malaysia: "Lot 18256, Kawasan Perindustrian Lot Q, Kertih Bio-Polymer Park, 24300 Kemaman, Terengganu, Malaysia." The testing standards cited are international (ASTM, ISO).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical permeation tests, and biocompatibility studies, not through expert consensus or interpretation of medical images/conditions. The performance is measured against established scientific and engineering standards (ASTM and ISO).
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against defined standards, not 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 not an AI-powered diagnostic or interpretive device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (glove), not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance of the medical gloves is established through:
- Standardized Physical and Mechanical Testing: Against ASTM D6319-19 requirements for dimensions, tensile strength, elongation, and residual powder.
- Permeation Testing: Against ASTM D6978-05 for chemotherapy drugs.
- Biocompatibility Testing: Against ISO 10993-5 (In Vitro Cytotoxicity - although the proposed device showed potential cytotoxicity, it was then deemed safe by the Acute Systemic Toxicity test), ISO 10993-10 for skin irritation and sensitization, and ISO 10993-11 for acute systemic toxicity.
These are all objective, laboratory-based measurement criteria rather than expert consensus, pathology, or outcomes data in a clinical setting.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical 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.