(35 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 Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-01 and FDA Water Leak Test.
The provided documentation describes the acceptance criteria and performance data for Non-Sterile Powdered Natural or Colored Latex Examination Gloves. This is a medical device, and the study described is a performance verification test against established industry standards. It is not an AI/ML device, therefore, many of the requested fields are not applicable.
Here's the breakdown of the information as it applies:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3578-01) | Reported Device Performance (POWDERED LATEX EXAM. GLOVES) |
|---|---|---|
| Watertight (1000ml) | Multiple Normal GI, AQL = 2.5 | Pass GI, AQL = 2.5 |
| Length (mm) | Min 220 (XS, S), Min 230 (M, L), - (XL) | 240 mm minimum for all sizes |
| Palm Width (mm) | 70 ± 10 (XS), 80 ± 10 (S), 95 ± 10 (M), 111 ± 10 (L), - (XL) | 73 - 78 (XS), 83 - 88 (S), 93 - 98 (M), 103 - 107 (L) |
| Thickness (mm) (Single Layer) | Min 0.08 (Finger), Min 0.08 (Palm) | Min 0.10 (Finger), Min 0.10 (Palm) |
| Physical Properties - Before Aging | ||
| Tensile Strength (MPa) | Min 18 | 26 - 30 |
| Ultimate Elongation (%) | Min 650 | 820 - 940 |
| Stress at 500% Elongation | Max 5.5 | 2.0 - 3.3 |
| Physical Properties - After Aging | ||
| Tensile Strength (MPa) | Min 14 | 24 - 30 |
| Ultimate Elongation (%) | Min 500 | 840 - 920 |
| Powder Content | 10mg per square decimetre max | Below 10 mg per square decimetre |
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., number of gloves tested for watertightness, length, etc.). It only references the ASTM D3578-01 standard, which would define the sampling plans. The data provenance is derived from internal testing conducted by YTY Industry (Manjung) Sdn Bhd in Malaysia, referencing internationally recognized standards. This is likely retrospective testing of manufactured batches to ensure compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This study involves physical and chemical property testing of a manufactured product against established engineering standards (ASTM D3578-01 and FDA Water Leak Test), not clinical interpretation requiring expert consensus. The "ground truth" is defined by the objective measurement parameters within these standards.
4. Adjudication Method for the Test Set
Not applicable. This type of testing does not involve subjective adjudication by human experts in the way clinical diagnostic studies do. The results are based on objective measurements and pass/fail criteria as defined by the standards.
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 document describes a medical device (examination gloves) that is not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective, measurable physical and chemical properties defined by established international standards:
- ASTM D3578-01: Standard for Latex Examination Gloves.
- FDA Water Leak Test: Specific for watertightness of medical gloves (1000ml test).
- Other referenced standards like ASTM D 5712-99, ASTM D 5151-99, ASTM D 6124-01, and ISO 2859 (likely for sampling procedures).
8. The Sample Size for the Training Set
Not applicable. This is a physical product undergoing performance verification, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As described above, there is no AI/ML model or corresponding training set.
§ 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.