(204 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 polymer-coating. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.
The provided text describes a 510(k) premarket notification for a medical device: "RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR." This document seeks to establish substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device submission.
Instead, the acceptance criteria are based on established ASTM standards for patient examination gloves, and the "study" is a series of non-clinical bench tests demonstrating the device's technical characteristics meet these standards and are comparable to the predicate device.
Here's the closest representation of the requested information based on the provided text, adapted for a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR" are derived from ASTM standards, primarily ASTM D3578-05 and ASTM D5712-99c1. The reported device performance is based on measurements taken on the new device and compared against these standards and the predicate device (K011271).
| Parameter | Acceptance Criteria (ASTM Specifications) | Reported Device Performance (Measured Values) |
|---|---|---|
| Physical Properties | ||
| Length, mm | 230 min. (ASTM D3578-05) | 290mm-305mm |
| Thickness (palm), mm | 0.08 min. (ASTM D3578-05) | 0.20mm-0.24mm |
| Thickness (finger), mm | 0.08 min. (ASTM D3578-05) | 0.23mm-0.26mm |
| Width (size: Small), mm | 80 ± 10 (ASTM D3578-05) | 82 mm – 85 mm |
| Width (size: Medium), mm | 95 ± 10 (ASTM D3578-05) | 89 mm – 94 mm |
| Width (size: Large), mm | 111 ± 10 (ASTM D3578-05) | 103 mm – 105 mm |
| Tensile Strength, Before Aging, Mpa | 18 min. (ASTM D3578-05) | 23.1 Mpa |
| Tensile Strength, After Aging, Mpa | 14 min. (ASTM D3578-05) | 29.6 Mpa |
| Ultimate Elongation, Before Aging, % | 650 min. (ASTM D3578-05) | 770 % |
| Ultimate Elongation, After Aging, % | 500 min. (ASTM D3578-05) | 830 % |
| Chemical Properties | ||
| Water Extractable Protein, µg/gram | 200 µg/glove max. (ASTM D5712-99c1) | 50 µg/glove and below |
| Residual Powder (size M), mg/glove | 2 mg/glove max. (ASTM D3578-05) | 2 mg/glove and below |
| Integrity Tests | ||
| Water Leak Test, Before Aging, AQL | 2.5 (ASTM D3578-05) | 1.5 and below |
| Water Leak Test, After Aging, AQL | 2.5 (ASTM D3578-05) | 2.5 and below |
| Biocompatibility | ||
| Skin Irritation Test | (ASTM F 720-81 implicit) | Passed* |
| Dermal Sensitization Test | (ASTM F 720-81 implicit) | Passed* |
Note: The document states "Passed" for biocompatibility tests, implying compliance with internal acceptance criteria based on the relevant ASTM standard. For these tests, specific numerical limits are not explicitly stated in the table but are inherent to the "Passed" designation. The ASTM F 720-81 standard is referenced for Biocompatibility Test.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for length, thickness, tensile strength, etc.). However, compliance with ASTM standards typically involves testing a statistically significant number of samples from production lots to ensure consistency and meet specified AQL (Acceptable Quality Level) values for certain tests like the Water Leak Test.
- Data Provenance: The tests were conducted on the "RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR" manufactured by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD in Malaysia. The tests are non-clinical, bench-top measurements of product characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical device involving physical and chemical property testing, not an AI/ML device relying on expert-adjudicated ground truth. The "ground truth" here is the objective measurement of the glove's parameters against established ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was involved. Test results were objectively measured against predefined limits in ASTM standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is a physical medical device, not an AI/ML diagnostic or treatment assistance tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment is based on objective measurements of physical and chemical properties against recognized industry standards (ASTM).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device and does not involve AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set. The device's characteristics are designed and manufactured to meet predefined specifications and then tested against those specifications.
§ 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.