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510(k) Data Aggregation
(34 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, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and study information for the SGMP Company Ltd. latex examination gloves, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Criteria (ASTM D3578-01aE2 or FDA Internal) | Reported Device Performance (SGMP) |
|---|---|---|---|
| Dimensions | X-Small (width) | 70 mm +/- 10 mm | 70 - 75 mm |
| Small (width) | 80 mm +/- 10 mm | 80 - 85 mm | |
| Medium (width) | 95 mm +/- 10 mm | 90 - 97 mm | |
| Large (width) | 111 mm +/- 10 mm | 105 - 111 mm | |
| Length (all sizes) | 230 mm minimum | 242 mm | |
| Thickness - Finger | 0.08 mm min | 0.08 mm min | |
| Thickness - Palm | 0.08 mm min | 0.08 mm min | |
| Physical Properties (Before Aging) | Tensile Strength | 14.0 Mpa | 22.0 - 30.2 Mpa (depending on size) |
| Ultimate Elongation | 700 % | 800 - 900 % (depending on size) | |
| Physical Properties (After Aging) | Tensile Strength | 14.0 Mpa | 24.6 - 28.3 Mpa (depending on size) |
| Ultimate Elongation | 500 % | 800 - 830 % (depending on size) | |
| Water Tight Test (Leakage) | Acceptable Quality Level (AQL) | 2.5% AQL (implied from FDA pinhole requirements) | Within 2.5% AQL (1-4 leaks out of 500 total tested) |
| Biocompatibility | General Biocompatibility | Passed tests for examination gloves (specifics not listed) | Passed the tests for examination gloves |
| Residual Powder Content | Residual Powder Content | 2 mg/glove max (FDA internal requirement) | Range: 0.5-0.9 mg/glove, Mean: 0.7 mg/glove |
| Presence of Cornstarch | Negative | Negative | |
| Residual Protein Level | Latex Protein Level (ASTM D 5712-99) | < 50 µg/g (FDA allowable level) | < 50 µg/g (claimed level) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Water Tight Test): 125 pieces for each of the four sizes (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested for the water tight test (125 * 4 * 2).
- Sample Size (Physical Properties): Not explicitly stated, but measurements are provided for each of the four sizes both before and after aging, suggesting multiple samples per size.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It is implied to be data collected specifically for the 510(k) submission, likely prospective, provided by the manufacturer (SGMP Company Ltd.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this device. The tests performed are objective, quantitative measurements of physical and chemical properties of the gloves, not assessments requiring expert interpretation (like medical images). The "ground truth" is defined by established international and FDA standards (e.g., ASTM D3578-01aE2, FDA internal requirements).
4. Adjudication Method for the Test Set
- This information is not applicable as the tests are objective measurements, not subjective evaluations that require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and comparing performance with and without AI assistance. This device is a medical glove, and its performance is assessed through laboratory-based physical and chemical tests, not human reading of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical product (medical glove), not an algorithm or software. Its performance is inherent in its physical properties and chemical composition.
7. The Type of Ground Truth Used
- The ground truth used for these tests is based on established industry standards and regulatory requirements. These include:
- ASTM D3578-01aE2 Standard Specification for Latex Examination Gloves for Medical Application
- ASTM D 6124-01 for Residual Powder Content
- ASTM D 5712-99 for Residual Protein Level
- FDA internal requirements (e.g., for residual powder content, pinhole AQL).
- Biocompatibility tests (details not provided in the summary but indicated as "per attached in APPENDIX L").
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The "training" here refers to the manufacturing process adhering to quality control.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" in the context of an AI/ML device. The ground truth for the manufacturing process is established by adherence to Good Manufacturing Practices (GMP) and the quality control standards outlined in section 7.
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