(196 days)
The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.
Powder Free Nitrile Examination Gloves, Blue meet all the requirements of ASTM standard D6319-00a, D6124-06 and FDA 21 CFR 880.6250.
Acceptance Criteria and Device Performance Study for DERMAGRIP ULTRA Powder Free Blue Nitrile Patient Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Current Device) |
|---|---|---|---|
| Dimensions | ASTM D6319-10 | Meets (Implicitly, as the standard specifies dimensional requirements for various sizes of examination gloves) | Meets |
| Physical Properties | ASTM D6319-10 | Meets (Implicitly, the standard outlines requirements for tensile strength, elongation, and ultimate elongation) | Meets |
| Thickness | ASTM D6319-10 | Meets (Implicitly, the standard specifies minimum and maximum thickness requirements at various points) | Meets |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | Meets (≤ 2 mg/glove) |
| Biocompatibility | Primary Skin Irritation: Consumer Product Safety Commission, Title 16, Chapter II, Part 1500:41 & 1500:3 (c)(4) | Not a primary skin irritant | Passes (Not a primary skin irritant) |
| Dermal Sensitization: Closed Patch Test ISO 10993-10:2002(E) | Not a contact sensitizer | Passes (Not a contact sensitizer) | |
| Watertight (1000ml) | ASTM D5151-06 | Passes (The standard specifies the water leak test and Acceptable Quality Limits (AQL) for pinholes, typically 1.5% AQL or better for medical gloves.) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for each specific test within the "Non-Clinical Performance Data" section. However, medical device testing, particularly for gloves, involves sampling from production lots. The results are reported as meeting the specified ASTM standards, which themselves define sampling plans and acceptable quality limits (AQL) for various tests.
The data provenance is not specified in terms of country of origin, but the submitter is from Malaysia (Advance Medical Products Sdn Bhd). The study appears to be retrospective, relying on performance data generated during the product development and quality assurance process, rather than a new prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The ground truth for this device (examination gloves) is established by adherence to recognized international and national standards (ASTM, ISO, and FDA regulations). These standards are developed and maintained by expert committees in their respective fields (e.g., materials science, toxicology, medical devices).
Therefore, the "ground truth" is the defined requirements and methodologies within these standards. The device's performance is measured against these objective criteria rather than subjective expert consensus on individual cases.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not relevant for the testing of examination gloves as described. The testing involves objective measurements to assess compliance with physical, chemical, and biological standards. Results are typically pass/fail based on predefined thresholds and statistical sampling plans outlined in the respective ASTM and ISO standards (e.g., AQL for pinholes). There is no subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of a computer-aided diagnostic (CAD) device on human reader performance for tasks like image interpretation. This device is a physical medical device (examination glove), not an AI/CAD system, and its performance is evaluated against objective technical standards, not against human reader performance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Device Performance" section and the "Non-Clinical Performance Data" explicitly describe tests conducted on the device itself (DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves) to determine if it meets the specified ASTM and ISO standards for:
- Dimensions
- Physical Properties (e.g., tensile strength, elongation)
- Thickness
- Powder content
- Biocompatibility (skin irritation and sensitization)
- Watertight integrity (pinholes)
These tests evaluate the algorithm-only performance, as the device's function is entirely self-contained within its physical properties and there is no human-in-the-loop interaction in its performance assessment beyond conducting the prescribed standardized tests.
7. Type of Ground Truth Used
The type of ground truth used is objective, standardized measurements and criteria defined by validated industry and regulatory standards. Specifically:
- ASTM (American Society for Testing and Materials) Standards: D6319-10 (for physical properties, dimensions, thickness), D6124-06 (for powder residue), D5151-06 (for watertight integrity/pinholes).
- ISO (International Organization for Standardization) Standard: ISO 10993-10:2002(E) (for dermal sensitization).
- Consumer Product Safety Commission Regulations: Title 16, Chapter II, Part 1500:41 & 1500:3 (c)(4) (for primary skin irritation).
These standards provide the pre-established, empirically validated metrics against which the device's performance is compared.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a physical medical device (examination gloves), not a machine learning or AI model that requires training data. The device's properties are inherent to its manufacturing process and materials.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" is not relevant for this type of device. The "ground truth" for evaluating the performance of examination gloves is established through rigorous, standardized testing methodologies detailed in the ASTM, ISO, and CPSC regulations. These standards define how to measure the intrinsic properties of the glove and the acceptable limits for those properties to ensure safety and effectiveness for its intended use.
§ 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.