(120 days)
Powder Free Blue Nitrile Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
The nitrile rubber is watertight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for the medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319-19 and ASTM D5151-19. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided text is a 510(k) premarket notification for "Powder Free Blue Nitrile Examination Gloves." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding AI/ML device performance and testing (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, effect size of human reader improvement with AI assistance) is not applicable to this document.
However, the document does contain information about performance testing for the physical and biological properties of the gloves, which can be interpreted as "acceptance criteria" and "reported device performance."
Here's the information extracted from the document that is relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" for these physical and biological properties:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing: | ||
| Guinea Pig Sensitization | No deviations noted, observed, nor requiring clarification. Product is not a sensitizer. | No reaction/positive allergic reaction observed. Conforms to requirements. |
| Primary Dermal Irritation in Rabbits | No deviations noted, observed, nor requiring clarification. Product is not a primary irritant. Primary Irritation Index (PII) of 0. | PII was 0. Conforms to requirements. |
| Acute Systemic Cytotoxicity in Rats | No adverse reaction noted, observed, nor requiring clarification. No adverse biological reaction. | All animals survived, healthy, active, gained weight. No abnormalities in gross necropsies. Conforms to requirements. |
| Physical Properties Testing (ASTM D6319-19, D5151-19, D6124-06): | ||
| Watertight (Pinhole Test) per ASTM D5151-19 | Free from holes, AQL 1.5 (G1: AQL 2.5 for 1000mL test) | Pass (G1: AQL 2.5 for 1000mL test) |
| Length (mm) | Size S: Min 220; M, L, XL: Min 230 | 240mm minimum for all sizes |
| Palm Width (mm) | Size S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10 | S: 84-86; M: 95-96; L: 108-109; XL: 114-115 |
| Thickness (mm) - Single Layer | Finger: Min 0.05; Palm: Min 0.05; Cuff: Min 0.05 | Finger: Min 0.06; Palm: Min 0.06; Cuff: Min 0.05 |
| Tensile Strength (MPa) - Before Aging | Min 14 | 17-23 |
| Ultimate Elongation (%) - Before Aging | Min 500 | 540-607 |
| Tensile Strength (MPa) - After Aging | Min 14 | 21-27 |
| Ultimate Elongation (%) - After Aging | Min 400 | 480-565 |
| Powder Content per ASTM D6124-06 | Max 2.0 mg/glove | Below 2.0 mg/glove |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for watertightness, physical properties, or number of animals for biocompatibility). It references ASTM and ISO standards, which would define the required sample sizes for such tests.
- Data Provenance: Not explicitly stated, but the tests were performed on the "proposed device" (Powder Free Blue Nitrile Examination Gloves manufactured by Lienteh Technology Sdn Bhd in Malaysia). The tests are described as non-clinical "performance data of gloves based on animal studies, biocompatibility studies" and "performance data of gloves based on ASTM D6319-19 and FDA Watertight Test." This implies prospective laboratory testing of the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML device relying on human expert annotation for ground truth. The "ground truth" for the physical and biological properties is established by the specified ASTM/ISO standard testing methodologies and their defined criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This document does not describe a study requiring human adjudication for test results; the outcomes are based on standardized laboratory measurements and observations according to specific protocols.
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 an examination glove, not an AI/ML diagnostic aid influencing human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove itself.
7. The type of ground truth used:
- The "ground truth" is based on standardized testing protocols and criteria defined by:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017), (Standard test method for Residual powder on medical gloves)
- ASTM D412-16 (for physical properties like tensile strength and elongation)
- ISO 10993-10:2010 (Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization)
- ISO 10993-11 (Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity)
- FDA watertight test AQL criteria (21 CFR 800.20)
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, it's not an AI/ML 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.