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510(k) Data Aggregation
(219 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
The provided text describes the 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color" (K211864). This document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. It specifically states that "Clinical testing is not needed for this device." Therefore, the requested information pertaining to AI/ML device studies, such as multi-reader multi-case studies, expert adjudication, training/test set ground truth establishment, or sample sizes for AI model development, is not applicable to this submission.
The document outlines the acceptance criteria and reported device performance based on non-clinical tests.
Here is the table summarizing the acceptance criteria and stated performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension Length | ≥ 230mm | 237 mm min for all sizes | Pass |
| Dimension Width | Small 70-90 mm | 85-87 mm | Pass | |
| Medium 85-105mm | 95-97 mm | Pass | ||
| Large 100-120mm | 105-107mm | Pass | ||
| X large 110-130 mm (from comparison table) | 115-117 mm (from comparison table) | Pass | ||
| Thickness | Fingertip ≥ 0.05 mm | 0.091mm | Pass | |
| Palm ≥ 0.05 mm | 0.072mm | Pass | ||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties: Tensile strength (Before & After aging) | ≥14MPa | 16.5-19.3 MPa | Pass |
| Physical Properties: Before aging Elongation | ≥500% | 526-560% | Pass | |
| Physical Properties: After aging Elongation | ≥400% | 432-492% | Pass | |
| • 21 CFR 800.20, • ASTM D 6319-06 (Reapproved 2015), • ASTM D5151-19 | Freedom from pinholes: Water leakage test | Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. | 2 noncompliance is allowed. | Pass |
| • ASTM D6319-10 (Reappr oved 2015), • ASTM D6124-06 (Reapproved 2017) | Powder Residual | <2mg/glove | Mean: 0.6-0.9 mg/pcs | Pass |
| Primary Skin Irritation in rabbits ISO 10993-10: 2010-08-01 | Biocompatibility | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes | Pass |
| Dermal sensitization in the guinea pig ISO 10993-10: 2010-08-01 | Biocompatibility | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes | Pass |
| The test article was added to L929 cells measured by MTT assay ISO 10993-5: 2009 | Biocompatibility | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern. | See Note below |
| Acute Systemic Toxicity Systemic injection in mice ISO 10993-11: 2017 | Biocompatibility | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Pass | Pass |
Note on Biocompatibility (Cytotoxicity): The device was found to be "cytotoxic" in the initial ISO 10993-5 test. However, the subsequent Acute Systemic Toxicity test (ISO 10993-11) passed, indicating that despite the in-vitro cytotoxicity, the device extracts do not pose a systemic toxicity concern in vivo. The document explicitly states: "Under the conditions of this study, the test article was shown potential toxicity to L-929 cells," but then for Acute Systemic Toxicity, it states, "Under the conditions of study, the device extracts do not pose a systemic toxicity concern (ISO 10993-11:2017)." This implies that the initial cytotoxicity finding was addressed and deemed not to be a safety concern in the context of systemic exposure.
Regarding the other requested information (2-9), as a 510(k) for a Class I medical device (patient examination gloves) that explicitly states "Clinical testing is not needed for this device," the following items are not applicable or not detailed in this submission because they are typically relevant for AI/ML-driven or image-analysis medical devices, which these gloves are not:
- Sample size used for the test set and the data provenance: Not applicable. These are physical product tests, not data-driven AI model tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (like glove dimensions, tensile strength, pinholes) is established by adherence to specified ASTM and ISO testing standards, not by expert consensus readings of images or data.
- Adjudication method for the test set: Not applicable.
- 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 not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for these tests is defined by established international standards (ASTM, ISO) for physical and chemical properties of gloves.
- The sample size for the training set: Not applicable. There is no AI model involved.
- How the ground truth for the training set was established: Not applicable.
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