(27 days)
Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are green in color and are powdered.
The provided document is a 510(k) summary for "POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". This type of device (examination gloves) is a well-established medical product, and its evaluation for regulatory clearance focuses on material properties, performance characteristics (like puncture resistance, tensile strength, and freedom from holes), and biocompatibility, rather than sophisticated signal processing or AI algorithms.
Therefore, many of the typical questions asked for AI/ML-driven medical devices, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "training set size," or "number of experts for ground truth," are not applicable to this submission. The device is a physical product, not a software algorithm.
Here's a breakdown of the requested information based on the provided text, with clarifications where questions do not apply:
1. A table of acceptance criteria and the reported device performance
The device is evaluated against the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The 510(k) summary explicitly states: "Gloves meet all the current ASTM D 6319-00a." and "MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a".
While the specific numerical acceptance criteria from ASTM D 6319-00a are not fully detailed in this 510(k) summary, the document indicates full compliance. ASTM D 6319-00a generally covers criteria such as:
| Characteristic | Acceptance Criteria (ASTM D 6319-00a - typical values, not fully specified in this document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Freedom from Holes | AQL 2.5 (e.g., Water Leak Test) | Meets all current specifications listed under ASTM Specification D 6319-00a |
| Tensile Strength | (e.g., typically ≥ 14 MPa for unbroken, ≥ 14 MPa for aged) | Meets all current specifications listed under ASTM Specification D 6319-00a |
| Elongation at Break | (e.g., typically ≥ 500% for unbroken, ≥ 400% for aged) | Meets all current specifications listed under ASTM Specification D 6319-00a |
| Puncture Resistance | (Specific requirements for examination gloves) | Meets all current specifications listed under ASTM Specification D 6319-00a |
| Biocompatibility | Primary Skin Irritation (non-irritant), Dermal Sensitization (non-sensitizer) | Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization. |
| Powder Content | Max 10 mg per glove (for powdered gloves) | Meets all current specifications listed under ASTM Specification D 6319-00a |
| Dimensions | Specific length, palm width, finger thickness, cuff thickness | Meets all current specifications listed under ASTM Specification D 6319-00a |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for each test within the ASTM D 6319-00a standard. ASTM standards typically define sampling plans (e.g., AQL levels for visual and physical defects), but the specific number of gloves tested is not in this summary.
- Data Provenance: The device manufacturer (Latexx Manufacturing Sdn. Bhd.) is located in Malaysia. The testing was performed according to ASTM D 6319-00a and 21 CFR 800.20 requirements. The details on where the tests were executed (e.g., specific lab location) are not provided. The nature of these tests (e.g., physical property measurements, biocompatibility) is prospective in the sense that they are performed on manufactured product batches to ensure compliance.
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)
This question is not applicable. The "ground truth" for examination gloves is established by objective physical and chemical testing (e.g., tensile strength machines, water leak tests, chemical analysis, animal biocompatibility studies), not by human expert interpretation in the same way as medical imaging or clinical diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used for subjective clinical assessments or interpretations where multiple observers might disagree. The tests for examination gloves are objective, laboratory-based measurements.
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
This question is not applicable. This device is an examination glove, not an AI software. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is established through:
- Standardized physical and mechanical property testing: Per ASTM D 6319-00a (e.g., measurements for tensile strength, elongation, dimensions, leak tests).
- Biocompatibility testing: Conducted using animal models for primary skin irritation (rabbit) and delayed contact sensitization (guinea pig). These are laboratory-derived ground truths based on standardized biological assay results.
8. The sample size for the training set
This question is not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This question is not applicable. There is no machine learning "training set" for this device.
§ 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.