(285 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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". It details the device's characteristics, intended use, and a comparison to a predicate device. The document explicitly states that clinical testing is not applicable and that clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
Therefore, there is no information in the provided text regarding a study that proves the device meets acceptance criteria related to AI or human-in-the-loop performance, as this is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.
However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted on the device, which are relevant for demonstrating its substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-2019 | ||
| Length | Min 230 mm for all sizes | X-Small: 303 mm | |
| Small: 304 mm | |||
| Medium: 305mm | |||
| Large: 306mm | |||
| X-Large: 307mm | |||
| Width (for specific sizes) | X-small: 70+/-10 mm | ||
| Small: 80+/-10 mm | |||
| Medium: 95+/-10mm | |||
| Large: 110+/-10 mm | |||
| X-Large: 120+/-10 mm | X-small: 74 mm | ||
| Small: 84 mm | |||
| Medium: 94 mm | |||
| Large: 104 mm | |||
| X-Large: 115 mm | |||
| Physical Properties | ASTM D6319-2019 | ||
| Before Aging: | |||
| Tensile Strength | 14 Mpa Min for all sizes | X-Small: 18.44 Mpa | |
| Small: 18.49 Mpa | |||
| Medium: 18.56 Mpa | |||
| Large: 18.62 Mpa | |||
| X-Large: 18.64 Mpa | |||
| Ultimate Elongation | 500% Min for all sizes | X-Small: 683% | |
| Small: 687% | |||
| Medium: 692% | |||
| Large: 695% | |||
| X-Large: 698% | |||
| After Aging: | |||
| Tensile Strength | 14 Mpa Min for all sizes | X-Small: 17.49 Mpa | |
| Small: 17.53 Mpa | |||
| Medium: 17.65 Mpa | |||
| Large: 17.71 Mpa | |||
| X-Large: 17.76 Mpa | |||
| Ultimate Elongation | 400% Min for all sizes | X-Small: 656% | |
| Small: 660% | |||
| Medium: 663% | |||
| Large: 666% | |||
| X-Large: 669% | |||
| Thickness | ASTM D6319-2019 | Palm 0.05 mm min | |
| Finger 0.05 mm min | Palm: 0.10 mm for all sizes | ||
| Finger: 0.12 mm for all sizes | |||
| Water Tightness | ASTM D5151-2019 | AQL-1.5 | Passes AQL 1.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | 2 mg/glove Max | X-Small: 0.21 mg/glove |
| Small: 0.21 mg/glove | |||
| Medium: 0.22 mg/glove | |||
| Large: 0.22 mg/glove | |||
| X-Large: 0.22 mg/glove | |||
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10 | 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 | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. |
| Acute Systemic Toxicity | ISO 10993-11:2017 | 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 |
| Material Mediated Pyrogenicity | ISO 10993-11:2017 / USP 41 | 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. |
Regarding the other requested information (2-9), as a physical medical device (gloves) and not an AI/software device, these questions are not applicable to the context of the provided document.
- 2. Sample size used for the test set and the data provenance: Not applicable. (These are physical tests on glove samples, not a test set for AI performance).
- 3. Number of experts and qualifications: Not applicable. (These are standardized physical and biological tests).
- 4. Adjudication method: Not applicable. (These are standardized physical and biological tests).
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted image interpretation or similar.
- 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is for AI algorithms.
- 7. Type of ground truth used: Not applicable in the AI sense. The "ground truth" for these tests comes from established industry standards (ASTM, ISO, USP) for physical and chemical properties and biological responses.
- 8. Sample size for the training set: Not applicable. Applies to AI/machine learning.
- 9. How the ground truth for the training set was established: Not applicable. Applies to AI/machine learning.
§ 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.