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510(k) Data Aggregation
(127 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
This document is a 510(k) summary for a medical device (Blue Nitrile Examination Glove Powder Free), demonstrating its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than clinical studies for novel AI/ML devices. Therefore, a direct application of the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for AI/ML performance (e.g., accuracy, sensitivity, specificity, MRMC studies) is not present here.
However, we can frame the information provided within the context of the requested questions by translating the device's technical specifications and performance data into a pseudo-"acceptance criteria" and "proof of meeting criteria."
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a physical device like a medical glove, "acceptance criteria" relate to its physical and biocompatibility properties, and "performance" refers to the test results demonstrating compliance with these standards.
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-10 (Reapproved 2015) | Length Min 230 mm; Width depends on size (e.g., Medium: 95+/-10mm) | Meets/Exceeds (e.g., Length Min 230mm, Medium Width 92mm) |
| Physical Properties | ASTM D6319-10 (Reapproved 2015) | Before Aging: Tensile Strength min 14 Mpa, Ultimate Elongation Min 500%After Aging: Tensile Strength min 14 Mpa, Ultimate Elongation Min 400% | Meets/Exceeds (e.g., Before Aging: 18.62Mpa, 694%; After Aging: 17.68Mpa, 668% for Medium) |
| Thickness | ASTM D6319-10 (Reapproved 2015) | Palm min 0.05 mm, Finger min 0.05 mm | Meets/Exceeds (e.g., Palm 0.09mm, Finger 0.15mm for all sizes) |
| Powder Residue | ASTM D6319-10 / ASTM D6124-06 | ≤2 mg/glove | Meets (e.g., 0.22 mg/glove for Medium) |
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015) | Passes AQL-1.5 | Passes AQL 1.5 |
| Biocompatibility: | |||
| Primary Skin Irritation | ISO 10993-10:2010(E) | Not an irritant | Not an irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) | Not a sensitizer | Not a sensitizer |
| In vitro cytotoxicity | ISO 10993-5:2009(E) | Non-cytotoxic | Cytotoxic (This is a discrepancy or a nuance to be explored within biocompatibility, as the acceptance criteria states "non cytotoxic" but result states "cytotoxic." Often, a cytotoxic result in vitro requires further in vivo investigation, but for gloves, the overall safety profile is considered.) |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) | Extracts do not pose a systemic toxicity concern | Extracts do not pose a systemic toxicity concern |
| Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41<151> | Non-pyrogenic | Non-pyrogenic |
| Bacterial Endotoxin | USP 42<85> | NMT 20 EU/pair of gloves | <20 EU/pair of gloves |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the specific numerical sample size for each test. Instead, it references conformity to ASTM and ISO standards, which typically prescribe statistical sampling plans. For instance, AQL (Acceptable Quality Level) 1.5 for water tightness implies a specific sampling size based on lot size, but the exact count isn't given.
- Data Provenance: The device is manufactured by Aspen Glove Sdn. Bhd. in Malaysia. The testing was presumably conducted by the manufacturer or a certified lab. The provenance of the "data" itself is from laboratory tests performed on the physical glove product. The data is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device. "Ground truth" from expert readers (like radiologists) is relevant for AI-powered diagnostic devices interpreting medical images. For a physical device like a glove, the "ground truth" is established by adherence to globally recognized consensus standards (ASTM, ISO, USP) and the results of laboratory tests performed according to validated methods. The "experts" involved are the scientists and technicians who perform these standardized tests and the regulatory bodies who define the standards.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used to establish ground truth in studies where human interpretation is subjective or requires consensus (e.g., AI in radiology). For a physical product's performance characteristics, the "adjudication" is inherently built into the standardized test methods, where results are measured objectively against defined 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. MRMC studies are designed for evaluating AI in diagnostic imaging by comparing human performance with and without AI assistance. This document describes a medical glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm in isolation. The document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established consensus standards and objective laboratory measurements (e.g., dimensions, tensile strength measured by equipment, chemical analysis for powder residue, standardized biological assays for biocompatibility). There is no "expert consensus" in the sense of physicians or pathologists interpreting findings, but rather adherence to scientifically defined parameters and test methodologies.
8. The sample size for the training set
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. Similar to point 8, there is no training set or corresponding ground truth establishment process for a physical device.
In summary: This FDA 510(k) submission for a medical glove demonstrates substantial equivalence primarily through non-clinical testing against established physical and biocompatibility standards. The framework requested (acceptance criteria, study design, expert involvement, etc.) is most appropriate for AI/ML-driven diagnostic or therapeutic devices, rather than traditional Class I or II physical medical devices where performance is assessed through standardized laboratory tests.
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