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510(k) Data Aggregation
(274 days)
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Non-Sterile, Powder Free Nitrile Examination Gloves – Orange, Green, Blue and Violet Color Color meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided text describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color," which is seeking substantial equivalence to a predicate device (K052502).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Ranges for Orange, Green, Blue, Violet) |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets (Specific ranges provided below) |
| Length (Size M) | Min 230 mm (Predicate: 240-251 mm) | Orange: 242-257 mm |
| Green: 240-249 mm | ||
| Blue: 240-250 mm | ||
| Violet: 240-244 mm | ||
| Palm Width (Size M) | 95 ± 10 mm (Predicate: 94-96 mm) | Orange: 96-100 mm |
| Green: 95-99 mm | ||
| Blue: 95-99 mm | ||
| Violet: 96-98 mm | ||
| Thickness Finger (Single Layer) | Min 0.05 mm (Predicate: 0.15-0.19 mm) | Orange: 0.11-0.14 mm |
| Green: 0.11-0.14 mm | ||
| Blue: 0.09-0.10 mm | ||
| Violet: 0.09-0.11 mm | ||
| Thickness Palm (Single Layer) | Min 0.05 mm (Predicate: 0.12-0.16 mm) | Orange: 0.09-0.11 mm |
| Green: 0.07-0.08 mm | ||
| Blue: 0.05-0.06 mm | ||
| Violet: 0.06-0.07 mm | ||
| Thickness Cuff (Single Layer) | Not explicitly stated in table | Orange: 0.07-0.09 mm |
| Green: 0.06-0.07 mm | ||
| Blue: 0.04-0.05 mm | ||
| Violet: 0.05-0.06 mm | ||
| Physical Properties | ASTM D6319-10 | Meets (Specific ranges provided below) |
| Before Aging: Tensile Strength (MPa) | Min 14 MPa (Predicate: 26.00-30.00 MPa) | Orange: 21.21-29.63 |
| Green: 24.15-29.21 | ||
| Blue: 28.46-33.44 | ||
| Violet: 23.22-29.11 | ||
| Before Aging: Ultimate Elongation (%) | Min 500% (Predicate: 750-800%) | Orange: 540-600 |
| Green: 580-620 | ||
| Blue: 520-580 | ||
| Violet: 520-580 | ||
| After Aging: Tensile Strength (MPa) | Min 14 MPa (Predicate: 25.00-28.00 MPa) | Orange: 29.23-33.56 |
| Green: 28.72-34.84 | ||
| Blue: 29.76-34.18 | ||
| Violet: 27.39-30.82 | ||
| After Aging: Ultimate Elongation (%) | Min 400% (Predicate: 670-730%) | Orange: 480-520 |
| Green: 520-540 | ||
| Blue: 440-520 | ||
| Violet: 440-500 | ||
| Freedom from Holes (Barrier) | ASTM D6319-10 (AQL = 2.5, FDA 1000ml Water Leak Test) | Meets (Holes found: 0 for all colors; Accept 1, Reject 7 criteria) |
| AQL | AQL 2.5 (Predicate: AQL 2.5) | AQL 2.5 (Result: 0 for all colors) |
| Powder-free | ASTM D6319-10 (Max 2.0 mg/glove) | Meets (Specific values below) |
| Residual Powder | Max 2.0 mg/glove (Predicate: 0.20 mg/glove) | Orange: 0.16 mg/glove |
| Green: 0.24 mg/glove | ||
| Blue: 0.20 mg/glove | ||
| Violet: 0.14 mg/glove | ||
| Bio-compatibility | ISO 10993-10 (2010), Non-irritant, Non-sensitizer | Meets (Under the conditions of the study, the device is non-irritant or non-sensitizer for all colors) |
Study Proving Device Meets Acceptance Criteria:
The document explicitly states that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application." The tables provided, particularly on pages 5 and 7, show the performance of the "Non-Sterile, Powder Free Nitrile Examination Gloves - Orange, Green, Blue and Violet Color" against these ASTM D6319-10 standards, and also against the FDA 1000ml Water Leak Test and ISO 10993-10 (2010) for biocompatibility.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The specific sample sizes for each test (e.g., how many gloves were tested for length, how many for freedom from holes) are not explicitly detailed. For the "Watertight (1000ml)" test, it mentions "Multiple Normal GII AQL = 2.5", and the acceptance criterion is "(Accept 1, Reject 7)", which implies a sampling plan based on AQL principles, but not a fixed number of samples. This is a common statistical sampling approach in quality control of manufactured goods.
- Data Provenance: The manufacturer is YTY Industry (Manjung) Sdn. Bhd., located in Sitiawan, Perak, Malaysia. Therefore, the data provenance is Malaysia. The study is a prospective test of the manufactured gloves against established standards, not a retrospective analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as it's not relevant for this type of device (nitrile examination gloves). The "ground truth" for glove performance is established by objective, standardized tests (ASTM, ISO, FDA methods), not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. As mentioned above, the performance of examination gloves is determined by objective physical and chemical testing against established standards, not by human adjudication of "ground truth".
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:
- A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert human readers interpret images or data, often with or without AI assistance. This device (examination gloves) does not involve human interpretation or AI assistance in its intended use or performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone algorithm performance study was not done. This device is a physical medical product, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance of these gloves is defined by established international and national standards and test methods:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- FDA 1000ml Water Leak Test
- ISO 10993-10 (2010) (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
- ASTM D6124-10 (Reapproved 2011) (Residual Powder on Medical Gloves)
- ASTM D5151-06 (Reapproved 2011) (Detection of Holes in Medical Gloves)
8. The sample size for the training set:
- This information is not applicable. This is a physical manufactured product, not an AI/ML algorithm that requires a "training set". The manufacturing process is subject to quality control and adherence to standards.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of medical device.
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