(43 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
The provided medical device is the "Chlorinated Powder Free Latex Examination Gloves" manufactured by SPI Gloves Sdn. Bhd. It is a Class I device regulated under 21 CFR 880.6250 (Latex Patient Examination Glove) with product code LYY.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Chlorinated Powder Free Latex Examination Gloves are based on meeting ASTM D3578-01a2 (or D3578-01a52, as both appear in the document for the same standard) and FDA requirements, including water leak test and minimum powder residual content.
| Test | Acceptance Criteria (ASTM D3578-01a2/a52 & FDA) | Reported Device Performance (Chlorinated Powder Free Latex Exam Gloves) |
|---|---|---|
| 1. Watertightness (1000 ml) | Pass AQL=2.5% | Pass AQL=2.5% |
| 2. Length (mm) - All Sizes | Min 230 | 240 mm minimum for all sizes |
| 3. Palm Width (mm) - XS | - | 110 mm |
| 4. Thickness (mm) - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| 4. Thickness (mm) - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| 5. Physical Properties - Before Aging - Tensile Strength (Mpa) | Min 14.0 | *19.9 |
| 5. Physical Properties - Before Aging - Ultimate Elongation (%) | Min 650 | *835 |
| 5. Physical Properties - After Aging - Tensile Strength (Mpa) | Min 14.0 | *16.5 |
| 5. Physical Properties - After Aging - Ultimate Elongation (%) | Min 500 | *786 |
| 6. Powder Content | Below 2mg / glove (FDA requirement) | Below 2mg / glove |
| 7. Protein Content | - | Below 50 microgram / gram |
| 8. Biocompatibility Test | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) Test | Passed Biocompatibility Tests |
Note: The document specifies "ASTM D3578-01a2" in the table heading and "ASTM D3578-01a52" in the general description of the standard. Assuming these refer to the same standard. The asterisk () for physical properties refers to average results obtained from Attachment C, which is not provided in the input.*
Details of the Study Proving Acceptance Criteria
The provided documentation describes the types of tests conducted and their outcomes, but it does not provide a detailed study report that would include specific sample sizes, ground truth establishment, or expert involvement as typically understood for AI/diagnostic device studies.
Based on the available information, here's what can be inferred and what information is missing:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test. For the "Watertight (1000 ml)" test, the Acceptance Quality Limit (AQL) of 2.5% is mentioned, which implies a sampling plan was used, but the specific sample size (e.g., number of gloves tested) is not given.
- Data Provenance: The tests were performed by the manufacturer, SPI Gloves Sdn. Bhd., in Malaysia. The type of study (e.g., retrospective or prospective) is not explicitly mentioned but these performance tests are typically conducted prospectively on manufactured batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and these physical/chemical performance tests. "Ground truth" established by experts is typically for diagnostic devices assessing medical images or clinical data. For examination gloves, the "ground truth" is defined by the objective measurement of physical and chemical properties against established standards (ASTM, FDA).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are used to resolve disagreements among human readers/experts in diagnostic studies. For these physical and chemical tests, the results are objective measurements from laboratory testing.
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:
- No, this was not done. This type of study is relevant for AI-powered diagnostic devices, not for examination gloves, which are physical barriers and do not involve human readers interpreting data enhanced by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI system, so the concept of standalone performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims of these gloves is defined by established regulatory and international standards (ASTM D3578-01a2/a52 and FDA requirements). For example, a glove is considered "watertight" if it passes the 1000 ml test with an AQL of 2.5%. "Tensile strength" is determined by mechanical testing against a minimum threshold. "Powder content" is determined by chemical analysis against a maximum threshold.
8. The sample size for the training set:
- Not applicable. This device is not an AI or machine learning model, so there is no "training set." The tests are performed on samples from manufacturing batches.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.
In summary:
The provided document demonstrates that the "Chlorinated Powder Free Latex Examination Gloves" meet the specified performance criteria based on objective physical and chemical testing against recognized standards (ASTM D3578-01a2/a52) and FDA requirements. The information required for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication, MRMC studies, or training data details) is not relevant for this type of medical device and is therefore not present in the submission.
§ 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.