(86 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, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.
The provided document details the acceptance criteria for "Blue Nitrile Examination Gloves Powder Free" and presents the results of non-clinical testing to demonstrate the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (Predicate / Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Dimensions | |||
| Length | ASTM D6319-2019 | Min 230 mm for all sizes | X-Small: 245 mm, Small: 245 mm, Medium: 246 mm, Large: 248 mm, X-Large: 248 mm |
| Width | ASTM D6319-2019 | X-small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | X-small: 76 mm, Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 115 mm |
| Physical Properties | |||
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm, Finger min 0.05 mm for all sizes | Palm: 0.09 mm (all sizes), Finger: 0.15 mm (all sizes) |
| Tensile Strength (Before Aging) | ASTM D6319-2019 | Min 14 Mpa for all sizes | X-Small: 22.76 Mpa, Small: 22.77 Mpa, Medium: 24.46 Mpa, Large: 24.51 Mpa, X-Large: 24.59 Mpa |
| Tensile Strength (After Aging) | ASTM D6319-2019 | Min 14 Mpa for all sizes | X-Small: 20.50 Mpa, Small: 20.50 Mpa, Medium: 21.81 Mpa, Large: 21.95 Mpa, X-Large: 22.05 Mpa |
| Ultimate Elongation (Before Aging) | ASTM D6319-2019 | Min 500% for all sizes | X-Small: 884%, Small: 885%, Medium: 888%, Large: 891%, X-Large: 892% |
| Ultimate Elongation (After Aging) | ASTM D6319-2019 | Min 400% for all sizes | X-Small: 867%, Small: 868%, Medium: 870%, Large: 872%, X-Large: 875% |
| Water Tight (Detection of Holes) | ASTM D5151-2019 | Passes AQL-1.5 | Gloves Passes AQL 1.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | ≤2 mg/glove | X-small: 0.16 mg/glove, Small: 0.16 mg/glove, Medium: 0.16 mg/glove, Large: 0.16 mg/glove, X-Large: 0.16 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 (Note: This result is listed as "cytotoxic" while the acceptance criteria is "non cytotoxic", which could be a typo or indicates further consideration is needed). |
| 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 |
From the table, the device performance meets or exceeds the acceptance criteria for all tested characteristics, with the exception of the "In vitro Cytotoxicity" test where the reported result is "cytotoxic" while the acceptance criteria is "non cytotoxic". This discrepancy needs clarification. However, in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS", the predicate also states "cytotoxic" for in vitro cytotoxicity, implying it might be an acceptable characteristic for this type of device or a different interpretation of cytotoxicity specific to gloves.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test. For example, for "Water Tight (1000 ml)" test, it mentions "Passes AQL-1.5", which implies a sampling plan was used according to the ASTM standard, but the specific number of gloves tested is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, beyond the fact that the tests were conducted according to international standards (ASTM, ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device under review is a medical glove, and the evaluation relies on adherence to established physical, chemical, and biological performance standards, not expert interpretation of medical images or cases. Ground truth for these tests is based on objective measurements and established test methodologies defined in the ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) where expert consensus is required. The testing for this device involves objective, quantitative measurements against predefined 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
This information is not applicable. The device is a medical glove. MRMC studies are relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on the objective measurements and predefined thresholds within recognized international standards (ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993-10, ISO 10993-5:2009, ISO 10993-11:2017, USP 41). For example:
- Dimensions: Measured length and width against minimum/range requirements.
- Physical Properties: Measured tensile strength and elongation against minimum percentage requirements.
- Water Tightness: Statistical sampling and inspection against an Acceptable Quality Level (AQL).
- Biocompatibility: Observation of biological responses (e.g., irritation, sensitization) following standardized protocols, compared against criteria for "not an irritant" or "not a sensitizer".
8. The sample size for the training set
This information is not applicable. The device is a medical glove, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of medical device.
§ 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.