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510(k) Data Aggregation
(131 days)
Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
The document provided is a 510(k) premarket notification for "Latex Examination Powder Free Gloves." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data against established standards for medical gloves, rather than clinical studies using AI.
Therefore, the requested information regarding AI study details (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, how ground truth for training was established) is not applicable to this submission, as it does not involve an AI/ML powered device.
However, I can extract the acceptance criteria and device performance based on the non-clinical tests described.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method & Purpose | Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| ASTM D3578-05 (Reapproved 2015) - Length | Min 230 mm for all sizes | X-Small: 236 mm, Small: 236 mm, Medium: 242 mm, Large: 248 mm, X-Large: 252 mm |
| ASTM D3578-05 (Reapproved 2015) - Width | X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 111+/-10 mm, X-Large: 115+/-10 mm | X-Small: 76 mm, Small: 85 mm, Medium: 98 mm, Large: 106 mm, X-Large: 116 mm |
| Physical Properties | ||
| ASTM D3578-05 (Reapproved 2015) - Thickness | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | All sizes (X-Small to X-Large): Palm 0.12 mm, Finger 0.14 mm |
| ASTM D3578-05 (Reapproved 2015) - Tensile Strength (Before Ageing) | 18 Mpa Min for all sizes | X-Small: 22.08 Mpa, Small: 22.16 Mpa, Medium: 22.22 Mpa, Large: 22.30 Mpa, X-Large: 22.32 Mpa |
| ASTM D3578-05 (Reapproved 2015) - Tensile Strength (After Ageing) | 14 Mpa Min for all sizes | X-Small: 18.50 Mpa, Small: 18.56 Mpa, Medium: 18.65 Mpa, Large: 18.74 Mpa, X-Large: 18.76 Mpa |
| ASTM D3578-05 (Reapproved 2015) - Ultimate Elongation (Before Ageing) | 650% Min for all sizes | X-Small: 856%, Small: 868%, Medium: 874%, Large: 880%, X-Large: 882% |
| ASTM D3578-05 (Reapproved 2015) - Ultimate Elongation (After Ageing) | 500% Min for all sizes | X-Small: 842%, Small: 850%, Medium: 855%, Large: 860%, X-Large: 862% |
| ASTM D3578-05 (Reapproved 2015) - Stress at 500% Elongation (Before Ageing) | 5.5 Mpa Max for all sizes | X-Small: 5.1 Mpa, Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.2 Mpa |
| Barrier Integrity | ||
| ASTM D5151-06 (Reapproved 2015) - Detection of Holes (Water Tight) | AQL 2.5 | Gloves Pass AQL 1.5 |
| Other Properties | ||
| ASTM D6124-06 (Reapproved 2017) - Residual Powder on Medical Gloves | 2 Mg/Glove Max | X-Small: 0.21 mg/glove, Small: 0.21 mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove |
| ASTM D5712-95 (Reapproved 2010) - Analysis of Protein in Natural Rubber | 200 µg/dm² Max for all sizes | All sizes (X-Small to X-Large): 32 µg/dm² |
| ISO 10993-10:2010(E) - Primary Skin Irritation | Not an irritant | Under the condition of study, not an irritant |
| ISO 10993-10:2010(E) - Dermal Sensitization | Not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009(E) - In vitro cytotoxicity | Non-cytotoxic | Under the conditions of the study, non-cytotoxic |
| ISO 10993-11:2017(E) / USP - Material mediated Pyrogenicity | Non-pyrogenic | Under the conditions of the study, non-pyrogenic |
| USP 42 <85> - Bacterial Endotoxin Test | <20 EU/pair of gloves (implied, based on comparison table data) | <20 EU/pair of gloves |
| ISO 10993-11:2017(E) - Acute Systemic Toxicity Test | Not systemic toxic | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document describes a series of non-clinical, controlled laboratory tests performed according to ASTM and ISO standards for medical gloves. Specific sample sizes for each test are not explicitly stated in the provided summary, beyond the "AQL 1.5" for water tightness (which relates to the acceptable quality level for sampling, not the total sample size tested).
- Data provenance: The tests were conducted to specific international and US standards (ASTM, ISO, USP). The manufacturing entity, Aspen Glove Sdn. Bhd., is based in Malaysia, suggesting the tests were likely performed in or commissioned by the manufacturer within that region, or by certified testing labs. The data is prospective for the purpose of demonstrating the device meets the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This is a non-AI device. Ground truth in this context refers to the defined scientific and engineering standards (e.g., ASTM, ISO) and the results of laboratory measurements against those standards. The "experts" are the qualified laboratory personnel conducting the tests and interpreting the results according to the test methodologies. The document does not specify the number or qualifications of these testing personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. This is a non-AI device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers to establish consensus ground truth for complex interpretations (e.g., medical image diagnosis). For physical and chemical tests, the results are objectively measured against established 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
- Not Applicable. This is a non-AI device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a non-AI device. "Standalone" performance testing refers to the evaluation of an AI algorithm without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is defined by the established performance specifications and methodologies outlined in the referenced standards (ASTM, ISO, USP). The device's characteristics (length, width, tensile strength, elongation, thickness, powder residue, extractable protein, biocompatibility, water tightness, bacterial endotoxin) are quantitatively measured and compared against the predefined numerical or qualitative acceptance criteria from these standards.
8. The sample size for the training set
- Not Applicable. This is a non-AI device and does not involve machine learning training sets.
9. How the ground truth for the training set was established
- Not Applicable. This is a non-AI device and does not have a "training set" or corresponding ground truth establishment process in the context of AI.
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