(50 days)
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91.
The document describes the acceptance criteria and performance of "COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)".
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D 3578-91) | Reported Device Performance (COMFIT Powder Free Blue Examination Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 |
| 2. Length (mm) | ||
| Size S | min 230 | 297 |
| Size M | min 230 | 303 |
| Size L | min 230 | 300 |
| Size XL | - | 293 |
| 3. Palm width (mm) | ||
| Size S | 80 ± 10 | 84 |
| Size M | 95 ± 10 | 95 |
| Size L | 111 ± 10 | 105 |
| Size XL | - | 118 |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.40 |
| Palm | min 0.08 | 0.30 |
| 5. Physical Properties | ||
| Before Ageing : | ||
| Tensile Strength (MPa) | min 21 | 31.23 |
| Ultimate Elongation (%) | min 700 | 895 |
| After Ageing : | ||
| Tensile Strength (MPa) | min 16 | 26.64 |
| Ultimate Elongation (%) | min 500 | 946 |
| 6. Powder Content | - (Implied maximum for "powder free") | below 2 mg / glove |
| 7. Protein Content | - (Implied maximum for "low protein" and "hypoallergenic") | below 50 microgram / gram |
2. Sample Size for the Test Set and Data Provenance
- Non-Clinical Performance Data: The sample sizes for the physical and watertight tests (length, palm width, thickness, tensile strength, elongation, powder content) are not explicitly stated, but the performance is presented as single values for each metric for each size. The "Watertight (1000 ml)" test results are reported against an AQL (Acceptable Quality Limit) of 2.5, indicating a sampling plan was used according to the ASTM and FDA standards. The provenance of this data is not specified beyond being generated by the device manufacturer.
- Clinical Performance Data (Hypoallergenic Claim):
- Sample Size: 200 human subjects.
- Data Provenance: Not explicitly stated, but implies a prospective clinical study conducted to assess the hypoallergenic claim.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical Performance Data: The document does not specify the number or qualifications of experts for establishing ground truth for the physical and chemical properties tests (e.g., tensile strength, protein content). These are standard laboratory tests typically performed by trained technicians according to established protocols (ASTM D 3578-91 and ASTM D5712 for protein content).
- Clinical Performance Data (Hypoallergenic Claim): The "Modified Draize test" is mentioned, which is a standardized patch test for skin irritation and sensitization. This test involves clinical assessment by trained personnel, typically dermatologists or clinical researchers. However, the document does not specify the number or specific qualifications of the experts (e.g., dermatologists with X years of experience) involved in assessing the 200 human subjects.
4. Adjudication Method for the Test Set
- Non-Clinical Performance Data: Not explicitly mentioned. Standardized tests (ASTM) usually have clear pass/fail criteria.
- Clinical Performance Data (Hypoallergenic Claim): Not explicitly mentioned. The Modified Draize test results would likely involve trained evaluators assessing skin reactions, but an explicit adjudication method (e.g., independent review by multiple experts) is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This document pertains to the performance of examination gloves, not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is "standalone" in the sense that it's the raw physical and chemical properties of the glove.
7. The Type of Ground Truth Used
- Non-Clinical Performance Data:
- Expert Consensus: Not explicitly stated. The "ground truth" for these measurements (e.g., length, tensile strength) is defined by the objective measurement obtained through validated laboratory testing methods (e.g., ASTM D 3578-91, ASTM D5712).
- Pathology/Outcomes Data: Not directly applicable. The data is based on physical and chemical measurements.
- Clinical Performance Data (Hypoallergenic Claim):
- Clinical Assessment/Outcomes Data: The ground truth for the hypoallergenic claim was established through clinical observation and assessment of the human subjects for dermal irritation or sensitization using the Modified Draize test. The outcome (presence or absence of reaction) serves as the ground truth.
8. The Sample Size for the Training Set
This question is not applicable as the device is an examination glove, not a machine learning model that requires a training set. The manufacturing process and quality control would be "trained" through process optimization and adherence to standards, but not in the sense of a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons mentioned in point 8.
§ 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.