(438 days)
The Powder Free Natural Rubber Latex Examination Gloves is a single use disposable device intended for medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
The Powder Free Natural Rubber Latex Examination Gloves meets all the requirements of ASTM Specification D3578-05(2010) Standard Specification for Rubber Examination Gloves standard.
The provided text describes the acceptance criteria and the device performance, but does not contain a study designed to prove the device meets these criteria in the typical sense of a clinical or analytical study. Instead, the document is a 510(k) summary for a medical device (examination gloves), which establishes substantial equivalence to existing legally marketed devices based on non-clinical performance standards.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS (Acceptance Criteria) | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D3578-05(2010) | Meets standard requirements |
| Physical Properties | ASTM D3578-05(2010) | Meets standard requirements |
| Thickness | ASTM D3578-05(2010) | Meets standard requirements |
| Biocompatibility | ISO 10993-10:2002/Amd 1:2006(E) Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity Amendment 1:2006-07-15 | Pass (Not a primary skin irritant) |
| Pass (Not a contact sensitizer) | ||
| Watertight (1000ml) | 21 CFR 800.20 | Pass |
Note regarding other criteria: The "Substantial Equivalence Comparison" table in section 9.0 also lists several characteristics with specific numerical requirements (e.g., Width, Length, Thickness, Tensile Strength, Elongation, Protein Content, Freedom from Holes). For the "Medtexx Manufacturing Sdn. Bhd." device, these are stated as meeting or passing the relevant ASTM or 21 CFR standards. For example:
- Width (Size Medium): Meets ASTM D 3578-05(2010): XS - 70 ± 10, S - 80 ± 10, M - 95 ± 10, L - 111 ± 10
- Overall length: Length ≥ 240mm
- Palm thickness: 0.08mm
- Finger thickness: 0.08mm
- Tensile Strength per aging min.: 18.0 MPa
- Tensile Strength after aging min.: 14.0 MPa
- Ultimate elongation pre aging min.: 650%
- Ultimate elongation after aging: 500%
- Residual powder test: Passes (meets applicable definition for Powder Free; $\le$ 2 mg per glove)
- Freedom from Holes: Meets Requirements per 21CFR800.20: Gloves Free of Holes at quality level of AQL 1.5
- Protein Content: Meets Applicable Definition for Protein Content; $\le$ max 50 (ug/dm²)
- Skin irritation: Passes
- Dermal sensitization: Passes
Study Details
The document states that "Clinical data is not needed for gloves or most devices cleared by the 510(k) process." This indicates that a traditional clinical study to "prove the device meets the acceptance criteria" was not conducted or required. Instead, the device's performance is demonstrated through compliance with established industry standards (ASTM, ISO) and FDA regulations (21 CFR). The basis for clearance is the "Substantial Equivalence" of the device to existing predicate devices, as shown by non-clinical performance data (i.e., laboratory testing against standards).
Given this, the following points address the specific questions based on the provided text, primarily indicating that these types of studies were not performed or are not applicable in this 510(k) context.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The document refers to "performance test data of non-clinical tests" but does not detail the sample sizes for these tests (e.g., how many gloves were tested for dimensions, physical properties, watertightness, biocompatibility, etc.).
- Data provenance: The submitting company, Worldmed Manufacturing Sdn. Bhd., is located in Malaysia. It is implied that the testing would have been conducted or overseen by the manufacturer or a contracted testing facility. The data itself would be considered retrospective in the sense that the tests were performed on manufactured glove samples to demonstrate compliance with standards for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. For this type of device (examination gloves), ground truth is established by adherence to engineering and performance standards (e.g., ASTM, ISO, FDA regulations) as measured in laboratory settings, not by expert consensus on clinical observations. Therefore, no "experts" in the sense of clinical reviewers establishing ground truth are mentioned or required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for studies where human interpretation or subjective assessment of data (e.g., medical images, clinical outcomes) is involved. The testing described for examination gloves involves objective physical and chemical measurements against predefined standards.
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. MRMC studies are used for evaluating diagnostic aids, especially in imaging, by comparing human readers' performance with and without assistance from a device. This is a very different type of device (examination gloves) where such a study design is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an examination glove, not an algorithm or a diagnostic tool that would have "standalone" performance in the context of AI or interpretive systems. Its performance is inherent to its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is the defined specifications and limits within the referenced national and international standards (ASTM D3578-05(2010), ISO 10993-10:2002/Amd 1:2006(E), 21 CFR 800.20). Performance is judged by whether the device's measured characteristics meet these established engineering and material science criteria.
- For biocompatibility, the "ground truth" is established by laboratory tests for irritation and sensitization, with "Pass" indicating no adverse biological reactions as defined by the ISO standard.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this device.
In summary: The provided text details how the examination gloves meet established engineering and biocompatibility standards through non-clinical laboratory testing. The basis for FDA clearance is "substantial equivalence" to predicate devices, not a clinical study proving effectiveness or safety in human subjects.
§ 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.