(23 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 Latex Examination Gloves
The provided text describes a 510(k) submission for "Powder-free Latex Examination Gloves" by Lovytex Sdn. Bhd. It includes acceptance criteria for the device and a summary of performance data.
Here's an analysis of the provided information, structured as requested:
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 DRAFT/FDA | 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 $\mu$ grams per gram |
| Cytotoxicity | Not explicitly stated, implied by "NON-TOXIC" | -MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours. |
| Rabbit Skin Irritation | Not explicitly stated, implied by "PASSES" | PASSES |
| Guinea Sensitization Study | Not explicitly stated, implied by "PASSES" | PASSES |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the various tests (Water Leak, Residual Powder, Tensile, Elongation, Water Extractable Protein, or biocompatibility tests).
The data provenance is Malaysia, as the applicant is Lovytex Sdn Bhd, located in Selangor Darul Ehsan, Malaysia.
The study appears to be retrospective in the sense that the data is presented as a summary of tests already conducted, presumably as part of the product development and validation process to meet established standards. It's not a prospective, controlled clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The tests refer to compliance with ASTM and FDA standards, which are established protocols, but the details of who performed or verified these tests are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided. The assessment relies on meeting or exceeding established ASTM and FDA standards. There's no mention of a human adjudication process for interpreting the test results beyond the statement that the device "meets or exceeds" the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with evaluating diagnostic imaging tools or AI-assisted diagnostic systems that rely on human-in-the-loop interpretation. The device described is a medical glove, which has different types of performance metrics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in essence, standalone performance was assessed. The tests described (Water Leak, Tensile, Elongation, Water Extractable Protein, Biocompatibility) are objective, laboratory-based physical and chemical tests of the glove itself. These tests measure the inherent properties of the device without human interpretation as part of the performance metric. The "algorithm" here is the physical product and its manufacturing process, and the performance is measured directly against standards.
7. The Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standards: For mechanical properties (Tensile, Elongation) and some general properties (Water Leak, Residual Powder, Water Extractable Protein).
- FDA Requirements: For pinhole requirements and implied biocompatibility standards.
- Expert Consensus (indirectly): The ASTM standards themselves are developed through expert consensus within the industry.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning or AI development. This device is a physical product (medical glove) and its performance is validated through physical and chemical testing, not through training an algorithm.
9. How the Ground Truth for the Training Set was Established
As the concept of a "training set" doesn't apply, this question is not relevant to the provided document.
§ 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.