(97 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. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves 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 document is a 510(k) premarket notification for a medical device (Blue Nitrile Powder Free Patient Examination Glove) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, or MRMC studies for an AI device.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physical properties, dimensions, watertightness, residual powder, and permeation to chemotherapy drugs.
However, to answer your request to the best of my ability based on the provided document and assuming the "device" refers to the Blue Nitrile Powder Free Patient Examination Glove, here's an interpretation of the relevant information provided:
Since this document pertains to a medical glove and not an AI/Machine Learning enabled device, the requested information regarding AI-specific criteria (e.g., human-in-the-loop, expert consensus for AI ground truth, MRMC studies) is not applicable and hence, not present in the provided text.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical tests conducted to demonstrate the safety and effectiveness of the medical glove.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally based on ASTM standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124) and outlined in the "Summary of Non-Clinical Testing 7.0" section, particularly in the tables on pages 11-14.
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Current Blue) | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412 | |||
| Before Aging: Tensile Strength | - | Min 14.0 MPa | 31.2 MPa | Pass |
| Before Aging: Ultimate Elongation | - | Min 500% | 594% | Pass |
| After Aging: Tensile Strength | - | Min 14.0 MPa | 34.7 MPa | Pass |
| After Aging: Ultimate Elongation | - | Min 400% | 553% | Pass |
| Dimensions (Example: X-Small) | ASTM D3767 | |||
| Length (X-Small) | - | Min 240 mm | 250 mm | Pass |
| Width (X-Small) | - | 70 ± 10 mm | 78.0 mm | Pass |
| Thickness Finger (X-Small) | - | Min 0.05mm | 0.10 mm | Pass |
| Thickness Palm (X-Small) | - | Min 0.05mm | 0.07 mm | Pass |
| Watertight | ASTM D5151 | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | 1 piece found with leaks (within acceptance criteria) | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | 0.26 mg/glove | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05(2019) (Minimum Breakthrough Detection Time in Minutes) | Varies by drug type (Implicitly, the device must meet or exceed predicate performance or established safety thresholds) | Values as listed in "Indications for Use" and "Table 1" (e.g., Carmustine: 23.0 min, Thiotepa: 98.8 min, others > 240 min) | Pass (compared to predicate) |
| Biocompatibility | ISO 10993-10, ISO 10993-5, ISO 10993-11 | Non-irritant, non-sensitizer, and no systemic toxicity. Cytotoxicity may be noted but compensated by other tests. | Non-irritant, non-sensitizer, no systemic toxicity. Cytotoxic effect noted, but acute systemic toxicity test passed. | Similar to predicate / Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document clearly states the sample sizes for certain tests:
- Watertight Test: 315 pieces (gloves) were used for this specific test.
- Residual Powder Test: 5 pieces (gloves) were used.
- Physical Properties & Dimensions: Specific sample sizes are not explicitly stated for these tests, but standards like ASTM D412 and D3767 would define the required sample sizes.
- Chemotherapy Drug Permeation: The specific number of gloves tested per drug type is not listed, but the test methodology (ASTM D6978-05(2019)) typically specifies this. The results are average breakthrough times.
Data Provenance: The tests were conducted by Rimba Glove Sdn Bhd, located in Perak, Malaysia (Submitter information on page 5). The data is non-clinical performance data for the device itself. It is inherently prospective testing of manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable as the "ground truth" for this device is established by physical measurement and chemical analysis against specified ASTM (American Society for Testing and Materials) standards. There are no human experts involved in "establishing ground truth" in the way a radiologist reviews images for an AI algorithm. The tests are objective laboratory measurements.
4. Adjudication Method for the Test Set:
Not applicable. This concept applies to subjective assessments, often in an AI context where multiple human readers disagree. Here, the tests are objective laboratory measurements (e.g., tensile strength, water leak detection, chemical permeation time).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a medical device (glove), not an AI/Machine Learning enabled device. MRMC studies are specific to evaluating diagnostic accuracy, often comparing human performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Machine Learning enabled device. The "standalone performance" is the performance of the glove itself against the defined physical and chemical standards.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is based on objective, measurable criteria defined by international standards (ASTM, ISO) for medical gloves and their material properties. This includes:
- Physical properties (tensile strength, elongation)
- Dimensional measurements (length, width, thickness)
- Integrity (watertightness)
- Chemical residue (residual powder)
- Permeation resistance to chemotherapy drugs.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/Machine Learning device that requires a training set. The device manufacturing processes are subject to Quality System Regulations (21 CFR Part 820), not machine learning training.
9. How the Ground Truth for the Training Set was Established:
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.