(122 days)
A 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.
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
The provided text describes the acceptance criteria and performance data for the "Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile". This is a medical device, and the data presented relates to its physical properties and biocompatibility, not an AI/ML-based device. Therefore, questions related to AI/ML specific aspects like expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable.
Here's the analysis based on the provided text, focusing on the relevant criteria for this type of medical device:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Tensile Strength (Before Aging) | ASTM D412 | Min 14.0 MPa | 32.35 MPa | Pass |
| Ultimate Elongation (Before Aging) | ASTM D412 | Min 500% | 568% | Pass |
| Tensile Strength (After Aging) | ASTM D412 | Min 14.0 MPa | 36.10 MPa | Pass |
| Ultimate Elongation (After Aging) | ASTM D412 | Min 400% | 551% | Pass |
| Length (Dimension) | ASTM D3767 | Min 240 mm | 249 mm | Pass |
| Width (Dimension) | ASTM D3767 | 95 ± 10 mm | 98 mm | Pass |
| Thickness - Finger (Dimension) | ASTM D3767 | Min 0.05 mm | 0.10 mm | Pass |
| Thickness - Palm (Dimension) | ASTM D3767 | Min 0.05 mm | 0.07 mm | Pass |
| Watertight | ASTM D5151 | AQL 1.5, Acceptance No. 10 for 315 samples | 0 pieces with leaks (for 315 samples) | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | 0.24 mg per glove | Pass |
| Biocompatibility | ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16. Chapter II, Part 1500 | Non-irritant and non-sensitizer | Negligible irritant response, no sensitization effect in guinea pigs | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | No systemic toxicity induced | No systemic toxicity induced | Pass |
2. Sample size used for the test set and the data provenance
- Physical Properties (Tensile Strength, Ultimate Elongation, Dimensions): The sample sizes are not explicitly stated for each specific test, but ASTM D412 and ASTM D3767 standards typically specify sample sizes for these types of tests.
- Watertight: The sample size used was 315 pieces (based on inspection level G1 for a batch size of 150,001 to 500,000 under AQL 1.5).
- Residual Powder: The sample size used was 5 pieces.
- Biocompatibility: The specific sample sizes for in vivo tests (like primary skin irritation, dermal sensitization, acute systemic toxicity) are not explicitly mentioned in terms of number of animals, but the standards (ISO 10993-10, ISO 10993-11) outline the appropriate sample sizes and methodologies for these studies.
- Data Provenance: The data is non-clinical test data conducted by Onetexx Sdn Bhd (Malaysia), indicated by the submitter's address. These are prospective tests performed on the device to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a patient examination glove, and its performance is assessed through standardized physical and chemical tests (e.g., tensile strength, watertightness, biocompatibility), not through expert interpretation of medical images or other data requiring "ground truth" established by human experts.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, especially when human interpretation is involved. For physical and chemical testing of medical gloves, results are determined by adherence to established test procedures and measurement against quantitative criteria.
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 question is not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device is established by objective measurements and standardized test procedures defined by ASTM and ISO standards (e.g., ASTM D412 for tensile properties, ASTM D5151 for watertightness, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this product's performance evaluation.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."
§ 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.