(217 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
HG PRO® Nitrile Powder Free Examination Gloves are substantially equivalent to the Class 1 patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided document describes the acceptance criteria and performance of the HG PRO® Nitrile Powder Free Examination Gloves, primarily comparing them to a predicate device (K022548) and relevant ASTM standards.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria / Standards | Reported Device Performance (Subject Device: HG PRO® Nitrile Powder Free Examination Gloves) |
|---|---|---|
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber |
| Color | - | Blue |
| Texture | - | Textured Fingers |
| Size | Medical Glove Guidance Manual - Labeling - Issued on January 22, 2008 | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Gloves Guidance Manual - Issued on January 22, 2008 | Single use |
| Dimension | ASTM D6319-10 | Meets ASTM D6319-10 |
| Length: | ||
| Extra Small = 220 mm minimum | ||
| Small = 220 mm minimum | ||
| Medium = 230 mm minimum | ||
| Large = 230 mm minimum | ||
| Extra Large = 230 mm minimum | ||
| Palm Width: | ||
| Extra Small = 60-80 mm | ||
| Small = 70-90 mm | ||
| Medium = 85-105 mm | ||
| Large = 100-120 mm | ||
| Extra Large = 110-130 mm | ||
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 |
| Finger: 0.05 mm min | ||
| Palm: 0.05 mm min | ||
| Physical Properties | ASTM D6319-10 | Meet ASTM D6319-10 |
| Tensile Strength: | ||
| 14 MPa min (before aging) | ||
| 14 MPa min (after aging) | ||
| Ultimate Elongation: | ||
| 500% min (before aging) | ||
| 400% min (after aging) | ||
| Watertight test (1000 ml) | ASTM D5151-06 | Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06 | Meet ≤ 2.0 mg/glove |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10: 2010 | |
| Dermal Sensitization - ISO 10993-10: 2010 | Pass | |
| Not a primary skin irritant under the conditions of the study | ||
| Not a contact sensitizer under the conditions of the study |
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 sample sizes used for each specific test (e.g., watertight test, physical properties). It refers to compliance with ASTM standards, which would dictate the sample sizes for those tests. The data provenance is not specified, but the manufacturer is based in Thailand (Healthy Glove Co., Ltd.). The studies appear to be prospective, laboratory-based tests conducted to meet established standards.
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 to the type of device and testing presented. The "ground truth" for examination gloves is established by meeting predefined physical, chemical, and biological standards (ASTM, ISO), not by expert consensus on clinical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is an examination glove, and its performance is evaluated against objective, measurable standards, not through adjudication by experts on subjective clinical interpretations.
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. This is not an AI-powered diagnostic device, but a physical medical device (examination glove). Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is established by objective, measurable physical, chemical, and biological performance standards as defined by organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:
- Dimensions: Measured against specified ranges (e.g., length, palm width).
- Thickness: Measured against minimum requirements.
- Physical Properties: Tensile strength and ultimate elongation measured against minimum requirements (before and after aging).
- Watertightness: Tested against leakage rates (AQL 1.5).
- Residual Powder: Measured against maximum limits.
- Biocompatibility: Tested for primary skin irritation and dermal sensitization using established biological evaluation standards (ISO 10993-10).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML 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.