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510(k) Data Aggregation
(192 days)
The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, \Vhite) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) includes variations of different size and color. The colors of the proposed device are Blue, and White.
The document describes the K202402 Nitrile Examination Gloves. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Standard) | Test Parameter | Proposed Device Performance (Minimum) | Predicate Device AQL (or value) |
|---|---|---|---|
| ASTM D6319-15 | Pinhole AQL | 1.5 | N/A (implied 1.5 by ASTM) |
| Tensile Strength (Before Aging) | 15 MPa | 15 MPa | |
| Ultimate Elongation (Before Aging) | 500 % | 500 % | |
| Tensile Strength (After Aging) | 14 MPa | 14 MPa | |
| Ultimate Elongation (After Aging) | 500 % | 400 % | |
| ASTM D5151-06 | Freedom from Holes | Free from holes | Free from holes |
| ASTM D6124-17 | Powder Content | Less than 2 mg per glove | Meet ASTM D6319 requirements |
| ISO 10993-10:2010 | Irritation | Not an irritant | Not an irritant |
| Sensitization | Not a sensitizer | Not a sensitizer | |
| ISO 10993-5:2009 | In vitro cytotoxicity | N/A (implied non-cytotoxic) | N/A (implied non-cytotoxic) |
| Biocompatibility | Acute Systemic Toxicity | Not toxic (for proposed device) | Not Available (for predicate) |
| Physical (Dimensions) | Length (XS, S, M) | 230 mm min | 230 mm min |
| Length (L, XL) | 235 mm min | 230 mm min | |
| Width | 70, 80, 95, 110, 120 mm (±10 mm) | 70, 80, 95, 110, 120 mm (±10 mm) | |
| Finger Thickness | 0.05 mm min | 0.10-0.12 mm (±0.03 mm) | |
| Palm Thickness | 0.05 mm min | 0.08-0.10 mm (±0.03 mm) | |
| Cuff Thickness | 0.05 mm min | 0.06-0.09 mm (±0.03 mm) |
Note: The document explicitly states that "The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319." and that the bench tests "demonstrated that the proposed device complies with the following standards".
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test that was performed. It generally refers to "bench tests" for physical properties and "biocompatibility tests".
- Provenance: No specific country of origin is mentioned for the test data itself, beyond the manufacturer being in China. The study is non-clinical bench testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical glove, and the "ground truth" for its performance is established by adherence to recognized international standards (ASTM, ISO) through objective physical and biocompatibility testing, not expert consensus on interpretations of complex medical images or outcomes.
4. Adjudication method for the test set
Not applicable, as the tests are objective measurements against standards.
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 medical glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove, not an algorithm.
7. The type of ground truth used
The ground truth used for performance evaluation is defined by international consensus standards for medical gloves (ASTM D6319-15, ASTM D5151-06, ASTM D6124-17) and biocompatibility testing standards (ISO 10993-10:2010, ISO 10993-5:2009). The device is tested against the specified parameters and thresholds outlined in these standards.
8. The sample size for the training set
Not applicable. This is a physical medical device (gloves), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device (gloves), not an AI algorithm.
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