(84 days)
The RubberCare powdered latex 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 made from natural rubber latex using USP cornstarch as donning powder. The manufacturing process includes pre and post leaching stages to remove residual chemicals and water-soluble proteins. The extent of protein removal is within the limit of the ASTM D3578-01a24 recommended limits for both powder and water-soluble protein.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | ASTM Specifications (Acceptance Criteria) | Reported Device Performance (Measured Values) |
|---|---|---|
| Length (sizes M, L) | 230 mm min. | 240 - 245 mm |
| Thickness (palm) | 0.08 mm min. | 0.14 - 0.16 mm |
| Thickness (finger) | 0.08 mm min. | 0.16 - 0.20 mm |
| Width (size M) | 95 ± 10 mm | 94 - 98 mm |
| Tensile Strength (Before Aging) | 18 Mpa min. | 20 - 29 Mpa |
| Tensile Strength (After Aging) | 14 Mpa min. | 20 - 26 Mpa |
| Ultimate Elongation (Before Aging) | 650% min. | 750 - 900% |
| Ultimate Elongation (After Aging) | 500% min. | 750 - 950% |
| Water Extractable Protein | 200 µg/dm² (recommended) | 100 µg/gram and below |
| Water Leak Test (Before Aging) (AQL) | 2.5 | 1.5 and below |
| Water Leak Test (After Aging) (AQL) | n.a. (not specified by ASTM) | 2.5 and below |
| Residual Powder | 10 mg/dm² | 9 - 10 mg/dm² |
| Skin Irritation Test | n.a. (not specified by ASTM) | Passed* |
| Dermal Sensitization Test | n.a. (not specified by ASTM) | Passed* |
Note: The document states these passed tests refer to "attachment H (page 19)" which is not included in the provided text, so specific criteria for these tests are not available here.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for testing each parameter. However, the data represents testing performed by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD, located in Seremban, Negeri Sembilan, Malaysia. The data is retrospective in the sense that it was collected and then summarized for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of study (material properties testing for medical gloves) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The acceptance criteria are established by the ASTM (American Society for Testing and Materials) standard D 3578-01a2, which represents a consensus of experts in the field of rubber products. The testing itself is performed by laboratory technicians following standardized procedures.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations, but rather laboratory testing against established specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes the performance of a medical device (gloves) against established material and performance standards, not a diagnostic algorithm that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this can be considered a "standalone" performance evaluation in the sense that the device's physical and chemical properties were tested in isolation against established standards, without human interaction influencing the measurement of these properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the ASTM D3578-01a2 standard specifications. These are industry-accepted, scientifically validated performance metrics for patient examination gloves.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The measurements presented are from a batch of manufactured gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The ground truth (ASTM standards) is established through a consensus process by the ASTM organization, involving experts in the field.
§ 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.