(322 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.
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.
However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (ASTM Specifications) | Reported Device Performance (K161833) | Status |
|---|---|---|---|
| Dimension (Length) | |||
| Size XSmall | 220 mm min. | 224mm-236mm | Meet Specification |
| Size Small | 220 mm min. | 225mm-240mm | Meet Specification |
| Size Medium | 230 mm min. | 235mm-246mm | Meet Specification |
| Size Large | 230 mm min. | 235mm-245mm | Meet Specification |
| Size XLarge | N/A | N/A | N/A |
| Thickness | |||
| Palm | 0.08 mm min. | 0.12mm-0.14mm | Meet Specification |
| Finger | 0.08 mm min. | 0.15mm-0.17mm | Meet Specification |
| Width | |||
| Size XSmall | 70 ± 10 mm | 73mm-75mm | Meet Specification |
| Size Small | 80 ± 10 mm | 82mm-87mm | Meet Specification |
| Size Medium | 95 ± 10 mm | 94mm-97mm | Meet Specification |
| Size Large | 111 ± 10 mm | 102mm-107mm | Meet Specification |
| Size XLarge | N/A | N/A | N/A |
| Physical Properties | |||
| Tensile Strength, Before Aging | 18 MPa min. | 21.18MPa-26.17MPa | Meet Specification |
| Stress at 500% Elongation | 5.5 MPa max. | 3.0MPa-4.2MPa | Meet Specification |
| Ultimate Elongation, Before Aging | 650% min. | 750.20%-820.20% | Meet Specification |
| Tensile Strength, After Aging | 14 MPa min. | 18.28MPa-23.88MPa | Meet Specification |
| Ultimate Elongation, After Aging | 500% min. | 550.40%-700.50% | Meet Specification |
| Water Leak Test, 1000 ml (AQL) | |||
| Before Aging | 2.5 | 1.5 and below | Meet Specification |
| After Aging | 2.5 | 2.5 and below | Meet Specification |
| Extractable Protein | |||
| Water Extractable Protein | 50 µg/dm² | 50 µg/dm² and below | Meet Specification |
| Residual Powder Content | |||
| Residual Powder Content | 2 mg/glove max. | 2 mg/glove and below | Meet Specification |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this submission.
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 that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).
4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
- 21 CFR 800.20 (dealing with devices that prevent contamination)
- ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
These standards define the acceptable performance limits for the characteristics tested.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.
§ 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.