(62 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
Powder-free Polymer Coated Latex Examination Gloves with protein label claim 50 micro-grams per gram
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-free Polymer Coated Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Reference Document) | Reported Device Performance |
|---|---|---|
| Water Leak | ASTM D 3578/FDA | Meets or Exceeds |
| Residual Powder | ASTM D 6124 | Meets or Exceeds |
| Tensile (Unaged) | ASTM D 3578-95 | Meets or Exceeds |
| Tensile (Aged) | ASTM D 3578-95 | Meets or Exceeds |
| Elongation @ Break (Unaged) | ASTM D 3578-95 | Meets or Exceeds |
| Elongation @ Break (Aged) | ASTM D 3578-95 | Meets or Exceeds |
| Water Extractable Protein | ASTM D 5712-95 | 50 u grams per gram |
| Cytotoxicity | (Not explicitly stated, but implied by "MEM test extract was NON-TOXIC") | MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours. |
| Rabbit Skin Irritation | (Not explicitly stated, but implied by "PASSES") | PASSES |
| Guinea Sensitization Study | (Not explicitly stated, but implied by "PASSES") | PASSES |
| Pinhole Requirements | FDA Pinhole Requirements | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set for any of the performance characteristics (e.g., water leak, tensile strength, protein content, biocompatibility tests).
The data provenance is retrospective, as this is a 510(k) submission summarizing data already collected. The country of origin of the data is implicitly Malaysia, given that the applicant, Lovytex Sdn Bhd, is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For performance tests on examination gloves, the "ground truth" is typically established by the standardized testing methodologies themselves (e.g., ASTM standards) rather than by human expert consensus or interpretation of images. Biocompatibility tests are also performed by trained laboratory personnel following specific protocols.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., image analysis by multiple radiologists) to resolve discrepancies. For objective performance tests of physical properties and chemical composition, such adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being assessed. This submission is for an examination glove, which does not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This question is not applicable to an examination glove. This is not an AI-driven device with an algorithm that performs tasks independently. The performance listed is that of the physical product itself.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements against established industry standards and regulatory requirements. Specifically:
- ASTM (American Society for Testing and Materials) standards for physical properties (Water Leak, Residual Powder, Tensile, Elongation @ Break, Water Extractable Protein).
- FDA Pinhole requirements.
- Biocompatibility test results (Cytotoxicity, Rabbit Skin Irritation, Guinea Sensitization Study) which have defined pass/fail criteria.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a "training set." The product's properties are inherent to its manufacturing process and materials.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.