(50 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 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water leak test.
This document describes the performance data and biocompatibility testing for non-sterile, powder-free, polymer-coated latex examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | ASTM D3578-01 Acceptance Criteria | Reported Device Performance (POWDER FREE LATEX EXAM. GLOVES) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm) | ||
| Size XS | Min 220 | 240 mm minimum for all sizes |
| Size S | Min 220 | 240 mm minimum for all sizes |
| Size M | Min 230 | 240 mm minimum for all sizes |
| Size L | Min 230 | 240 mm minimum for all sizes |
| Size XL | - (No direct criteria stated, but expected to meet general length requirements based on other sizes) | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| Size XS | 70 ± 10 | 73 - 78 |
| Size S | 80 ± 10 | 83 - 88 |
| Size M | 95 ± 10 | 93 - 98 |
| Size L | 111 ± 10 | 103 - 107 |
| Size XL | - (No direct criteria stated) | - (Data not provided in the table, but implied to be within acceptable range for that size) |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical Properties | ||
| Before Aging | ||
| Tensile Strength (MPa) | Min 18 | 23 - 25 |
| Ultimate Elongation (%) | Min 650 | 800 - 860 |
| Stress at 500% Elongation | Max 5.5 | 2.1 - 2.7 |
| After Aging | ||
| Tensile Strength (MPa) | Min 14 | 22 - 24 |
| Ultimate Elongation (%) | Min 500 | 800 - 860 |
| 6. Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each individual test. The document refers to "Multiple Normal GI AQL = 2.5" for the watertight test, which implies a sampling plan from ASTM D3578-01, but the exact number of gloves tested is not provided.
- Data Provenance: The document is a 510(k) summary submitted by YTY Industry (Manjung) Sdn Bhd, located in Perak Darul Ridzuan, Malaysia. The data is retrospective, as it represents performance testing conducted to demonstrate compliance with standards for the device described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is established by compliance with standardized test methods (ASTM D3578-01 and FDA 1000ML watertight test) and measured physical/chemical properties, not through expert consensus on qualitative data.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving subjective assessment or decision-making that would require an adjudication method like 2+1 or 3+1. The tests involve objective measurements and adherence to specified limits.
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 device is a medical glove, not an AI-assisted diagnostic or imaging tool. There is no human reader or AI component involved in its performance assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device (gloves), not an algorithm or software. Its performance is assessed through laboratory testing against established specifications.
7. The Type of Ground Truth Used
The ground truth used for this device is based on standardized specifications and laboratory measurements. This includes:
- ASTM D3578-01 Standard: A consensus standard for rubber examination gloves, defining various physical properties and performance requirements.
- FDA 1000ML watertight test: A specific requirement from the FDA for glove integrity.
- FDA minimum Powder Residual Content requirements: A regulatory limit for powder content.
- Protein labeling claim: A specific claim regarding the maximum allowable water extractable protein content.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is relevant for this 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.