(56 days)
The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined. It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.
It is the powder-free variation of the class II latex patient examination gloves made by washing the gloves in a chlorine solution followed by an effective chemical removal and acid neutralization steps. 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 device in question is a pair of Rubbercare Powder-Free/Guardian Powder-Free Latex Examination Gloves with a Protein Labeling Claim (50 micrograms or less).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (ASTM Specifications) | Reported Device Performance (Measured Values) |
|---|---|---|
| Length, mm | 230 min. | 240 - 245 |
| Thickness (palm), mm | 0.08 min. | 0.14-0.16 |
| Thickness (finger), mm | 0.08 min. | 0.16-0.20 |
| Width (size M), mm | 95 ± 10 | 94 - 98 |
| Tensile Strength, Before Aging, Mpa | 21 min. | 24 - 32 |
| Tensile Strength, After Aging, Mpa | 16 min. | 20 – 28 |
| Ultimate Elongation, Before Aging, % | 700 min. | 800 - 900 |
| Ultimate Elongation, After Aging, % | 500 min. | 700 - 800 |
| Water Extractable Protein, µg per gm | n.a. (implicit "50 and below" by claim) | 50 and below |
| Water Leak Test, Before Aging, AQL | 2.5 | 1.5 and below |
| Water Leak Test, After Aging, AQL | 4.0 | 2.5 and below |
| Residual Powder (size M), mg | 2 mg/glove | 1 mg/glove |
| Skin Irritation Test | n.a. (implicit "Passed" by claim) | Passed * |
| Dermal Sensitization Test | n.a. (implicit "Passed" by claim) | Passed * |
Note: "n.a." for Protein, Skin Irritation, and Dermal Sensitization implies that these were specific claims or tests conducted without a direct numerical ASTM specification provided in the table, but the results were explicitly stated to "Pass" or meet a defined threshold (like "50 and below" for protein). The document explicitly states these "meet all the requirements of ASTM standard D 3578-99" and other FDA requirements.
The study conducted to prove the device meets these criteria is an internal product testing and evaluation process by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD. The results, as presented in the table, demonstrate the glove's compliance with the ASTM standard D 3578-99, FDA pinhole requirements, and the protein content labeling claim.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific sample sizes for each test (e.g., how many gloves were tested for length, thickness, tensile strength, etc.). It provides ranges of "Measured Values" which suggests that multiple samples were tested for each parameter.
- Data Provenance: The testing was conducted by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD, a Malaysian company. Therefore, the data originates from Malaysia. The study is retrospective in the sense that the data presented reflects tests already performed on the manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This type of device (patient examination gloves) does not typically involve "experts" establishing a subjective ground truth in the way medical imaging or diagnostic devices might.
- The "ground truth" for these tests is based on objective, standardized measurements performed according to ASTM standards and FDA requirements. The measurements are taken by laboratory personnel or quality control technicians. The document does not specify the number or qualifications of the individuals who performed these measurements, but it is implied they are qualified to conduct such tests according to established protocols.
4. Adjudication Method for the Test Set:
- Adjudication methods like "2+1" or "3+1" are not applicable here. This refers to consensus building among multiple human reviewers for subjective assessments.
- For objective laboratory tests of physical properties and chemical content, the results are quantitative measurements. The "adjudication" is inherent in the measurement protocol itself, with results being compared directly against the specified ASTM and FDA thresholds. If a measurement falls within the acceptable range, it passes; otherwise, it fails.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of medical imaging or diagnostic AI on human reader performance, which is not relevant for physical medical devices like examination gloves.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone "algorithm only" study was not done. This device is a physical product, not an AI algorithm. The performance is assessed directly through physical and chemical testing, not through an algorithm's output.
7. Type of Ground Truth Used:
- The ground truth used for this study is based on objective, measurable criteria defined by:
- ASTM standard D 3578-99 for Latex Examination Gloves.
- FDA pinhole requirements.
- Company's own labeling claim for protein content (50 micrograms or less).
- FDA biocompatibility requirements (implied by "Passed*" for Skin Irritation and Dermal Sensitization tests, which likely refer to ISO 10993 or similar standards).
8. Sample Size for the Training Set:
- This concept is not applicable here. "Training set" refers to data used to train a machine learning algorithm. This device is a manufactured physical product, not an AI or software device that undergoes a training process.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no training set for a physical examination glove.
§ 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.