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510(k) Data Aggregation
(44 days)
A 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.
Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (<50ug/g) and Polycoating Class I Device, 80LYY
This document describes the acceptance criteria and performance of Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (<50ug/g) and Polycoating (K023577).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-01A62 and FDA 1000ML watertight test) | Reported Device Performance (YTY INDUSTRY POWDER FREE LATEX EXAM. GLOVES) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm) | ||
| XS | Min 220 | 240 mm minimum for all sizes |
| S | Min 220 | 240 mm minimum for all sizes |
| M | Min 230 | 240 mm minimum for all sizes |
| L | Min 230 | 240 mm minimum for all sizes |
| XL | - | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| XS | 70 ± 10 | 73 - 78 |
| S | 80 ± 10 | 83 - 88 |
| M | 95 ± 10 | 93 – 98 |
| L | 111 ± 10 | 103 - 107 |
| XL | - | - |
| 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 - 27 |
| Ultimate Elongation (%) | Min 650 | 820 - 900 |
| Stress at 500% Elongation | Max 5.5 | 2.9 - 3.8 |
| 5. Physical Properties After Aging | ||
| Tensile Strength (MPa) | Min 14 | 22 - 26 |
| Ultimate Elongation (%) | Min 500 | 780 - 860 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
In addition to the above, the device also met or exceeded the following standards and/or tests:
- ASTM D 5712-99
- ASTM D 3578-01aE2
- ASTM D 6124-01
- ASTM D 5151-99
- ISO 2859
- Bio-Compatibility: Dermal Sensitization
- Bio-Compatibility: Primary Skin Irritation
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific sample size for each test. However, the tests are based on ASTM and FDA standards (ASTM D3578-01 and FDA 1000ML watertight test, ASTM D 5712-99, ASTM D 3578-01aE2, ASTM D 6124-01, ASTM D 5151-99, ISO 2859). These standards typically prescribe specific sampling plans for testing.
The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). The gloves are manufactured by YTY INDUSTRY (MANJUNG) SDN BHD, which is a Malaysian company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM, FDA, ISO) through quantitative measurements, not by expert consensus on qualitative data.
4. Adjudication method for the test set
This information is not applicable for a physical product testing against quantitative standards. The results are objective measurements against predefined criteria.
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 information is not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device corresponds to the established acceptance criteria defined by international and national standards for medical gloves (ASTM D3578-01, FDA 1000ML watertight test, ASTM D 5712-99, ASTM D 3578-01aE2, ASTM D 6124-01, ASTM D 5151-99, ISO 2859). Compliance is determined by objective physical and chemical tests against these specified values.
8. The sample size for the training set
This information is not applicable. This is a manufactured product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is a manufactured product, not a machine learning model.
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