(150 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.
JR MEDIC 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.
The provided text is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free." It details the device's technical characteristics, non-clinical performance, and comparison to a predicate device to demonstrate substantial equivalence.
This document describes the testing of a medical device (examination gloves), which
Does not involve AI, machine learning, or complex algorithmic performance in its functionality or assessment. The tests performed are
physical, chemical, and biological compatibility tests of the material itself.
Therefore, the requested information regarding acceptance criteria and study proving AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document. The document describes the data and testing for a Class I medical device (gloves) and demonstrates its "substantial equivalence" to an existing predicate device, primarily through non-clinical bench testing and biocompatibility studies.
However, I can extract the acceptance criteria and reported performance for the physical and biological properties of the gloves, as provided in the document.
Acceptance Criteria and Reported Device Performance for Blue Nitrile Examination Gloves Powder Free
Since this is a physical medical device (gloves) and not an AI/ML-driven device, the criteria typically associated with AI/ML performance (e.g., AUC, sensitivity, specificity for a diagnostic algorithm) are not relevant here. Instead, the acceptance criteria relate to the physical properties, chemical composition, and biocompatibility of the gloves, demonstrating they meet established standards for medical examination gloves.
Here's the table of acceptance criteria and reported device performance based on the non-clinical testing summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Physical Properties | ||||
| Length | ASTM D6319-10 (Reapproved 2015) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 404 mm |
| Small: 404 mm | ||||
| Medium: 405 mm | ||||
| Large: 404 mm | ||||
| X-Large: 404 mm | ||||
| Width | ASTM D6319-10 (Reapproved 2015) | To determine the width of the gloves | X-small: 70+/-10 mm | |
| Small: 80+/-10 mm | ||||
| Medium: 95+/-10 mm | ||||
| Large: 110+/-10 mm | ||||
| X-Large: 120+/-10 mm | X-small: 74 mm | |||
| Small: 84 mm | ||||
| Medium: 94 mm | ||||
| Large: 105 mm | ||||
| X-Large: 115 mm | ||||
| Thickness | ASTM D6319-10 (Reapproved 2015) | To determine the thickness of the gloves | Palm 0.05 mm min | |
| Finger 0.05 mm min for all sizes | Palm: | |||
| X-Small: 0.20mm | ||||
| Small: 0.19mm | ||||
| Medium: 0.20mm | ||||
| Large: 0.20mm | ||||
| X-Large: 0.20mm | ||||
| Finger: | ||||
| X-Small: 0.22mm | ||||
| Small: 0.21mm | ||||
| Medium: 0.22mm | ||||
| Large: 0.21mm | ||||
| X-Large: 0.22mm | ||||
| Tensile Strength | ASTM D6319-10 (Reapproved 2015) | To determine the physical properties | Before Ageing: 14Mpa Min for all sizes | |
| After Ageing: 14Mpa Min for all sizes | Before Ageing: | |||
| X-Small: 22.0Mpa | ||||
| Small: 23.0Mpa | ||||
| Medium: 25.6Mpa | ||||
| Large: 24.0Mpa | ||||
| X-Large: 24.5Mpa | ||||
| After Ageing: | ||||
| X-Small: 18.5Mpa | ||||
| Small: 20.5Mpa | ||||
| Medium: 22.0Mpa | ||||
| Large: 21.0Mpa | ||||
| X-Large: 21.7Mpa | ||||
| Ultimate Elongation | ASTM D6319-10 (Reapproved 2015) | To determine the physical properties | Before Ageing: 500% Min for all sizes | |
| After Ageing: 400% Min for all sizes | Before Ageing: | |||
| X-Small: 898% | ||||
| Small: 896% | ||||
| Medium: 868% | ||||
| Large: 899% | ||||
| X-Large: 874% | ||||
| After Ageing: | ||||
| X-Small: 872% | ||||
| Small: 861% | ||||
| Medium: 828% | ||||
| Large: 869% | ||||
| X-Large: 853% | ||||
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015) | To determine the holes in the gloves | AQL 2.5 | Gloves pass AQL 1.5 (This meets or exceeds the AQL 2.5 criteria, as a lower AQL indicates fewer allowable defects). |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | 2 mg/glove Max | X-small: 0.16 mg/glove |
| Small: 0.20 mg/glove | ||||
| Medium: 0.21 mg/glove | ||||
| Large: 0.20 mg/glove | ||||
| X-Large: 0.21 mg/glove | ||||
| Biocompatibility | - | |||
| Primary Skin Irritation | ISO 10993-10:2010(E) | To determine the potential to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) | To determine skin sensitization potential in Guinea Pig | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009(E) | To evaluate in vitro cytotoxic potential in L-929 mouse fibroblasts cells | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. (This indicates an initial result that was followed up to ensure safety). |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) | To determine acute systemic toxicity potential in swiss Albino mice | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern. (This addresses the concern from the cytotoxicity test). |
| Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41 | To determine pyrogenic potential in New Zealand white Rabbits | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
Since the device is a simple medical examination glove and not an AI/ML system, the following points regarding AI/ML study design are explicitly not applicable to the data provided in this document:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on physical and chemical tests on manufactured gloves, not a "test set" of patient data for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by adherence to physical standards (ASTM) and biological safety (ISO, USP), not expert annotation of medical images/data.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for performance assessment of diagnostic/AI tools with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is compliance with established international standards for physical properties and biocompatibility of medical gloves.
- The sample size for the training set: Not applicable. There is no training set as there is no AI/ML model.
- How the ground truth for the training set was established: Not applicable.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.