(113 days)
A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.
The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.
The provided text describes the acceptance criteria and the methods used to demonstrate substantial equivalence for the "Safe Shield Powder-Free Latex Examination Gloves." Since this is a medical device (gloves), the "performance" metrics relate to physical properties and barrier integrity rather than a complex AI algorithm's diagnostic accuracy. Therefore, several points in your requested output (like MRMC studies, effect size of AI assistance, expert qualifications, etc.) are not applicable in this context.
Here's the breakdown of the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Minimum) | Reported Device Performance (Minimum) | Test Method/Standard |
|---|---|---|
| Physical Dimensions: | ASTM 3578-00 | |
| Length: 230 mm | 230 mm | |
| Thickness: 0.08 mm | 0.08 mm | |
| Width (Small): $80 \pm 10$ mm | $80 \pm 10$ mm | |
| Width (Medium): $95 \pm 10$ mm | $95 \pm 10$ mm | |
| Width (Large): $110 \pm 10$ mm | $110 \pm 10$ mm | |
| Physical Properties: | ||
| Before Aging: | ||
| Tensile Strength: 21 Mpa | 21 Mpa | ASTM 3578-00 |
| Ultimate Elongation: 700% | 700% | ASTM 3578-00 |
| After Aging: | ||
| Tensile Strength: 16 Mpa | 16 Mpa | ASTM 3578-00 |
| Ultimate Elongation: 500% | 500% | ASTM 3578-00 |
| Pin Hole (Water Tight Test): | 1000 ml Water fill | |
| AQL: 4.0 | Meets AQL 4.0 | 21 CFR 800.20, |
| MIL-STD-105E | ||
| Dimensions (Sampling/AQL): | MIL-STD-105E | |
| AQL: 4.0 | Meets AQL 4.0 |
Note: The text states "The physical specifications are as follows:" and then lists specific values for length, thickness, width, tensile strength, and ultimate elongation. These values are presented as minimums or exact specifications which the device must meet. The table above assumes the device met these exact listed values to claim substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The text refers to "Sampling and AQLs" for the Water Tight Test and Dimensions. For the Water Tight Test, it specifies "G-II" general inspection level and for Dimensions it specifies "S-2" special inspection level, derived from MIL-STD-105E. However, the exact number of units sampled for these tests is not explicitly stated in the provided text, only the inspection levels and AQLs.
- Data Provenance: The text does not provide information about the country of origin of the data or whether the tests were retrospective or prospective. It implies the performance testing was conducted by Safe Shield Co. Ltd. in Thailand.
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)
Not applicable. This device is a physical barrier protection device (gloves), not an diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for gloves is adherence to physical performance specifications and barrier integrity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies, often involving expert readers. This is not relevant for the physical testing of examination gloves.
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 device is a medical glove, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by conformance to recognized standards and regulatory requirements for physical properties and barrier integrity.
- Physical dimensions and properties: Based on ASTM 3578-00.
- Pin hole testing (water tightness): Based on the FDA's "1000 ml Water fill test method" as described in 21 CFR 800.20, with sampling derived from MIL-STD-105E.
8. The sample size for the training set
Not applicable. There is no "training set" for physical testing of medical gloves. This term typically refers to data used to train machine learning models.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.