(44 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 Nitrile Examination Gloves
This document is a 510(k) submission for Lovytex Powder-free Nitrile Examination Gloves (K981179). The acceptance criteria and the study proving the device meets them are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Reference Document) | Reported Device Performance (Lovytex Device) |
|---|---|---|
| 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 | Does not meet ASTM D 3578-95; BUT meets ASTM D 5250 (Vinyl) |
| Elongation @ Break (Aged) | ASTM D 3578-95 | Meets or Exceeds |
| Pinhole Requirements | FDA | Meets |
| Cytotoxicity | -MEM test | Non-toxic at dilution 1:4 at 24 hours |
| Rabbit Skin Irritation | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, the tests are laboratory-based performances of the glove material. The manufacturer is Lovytex Sdn Bhd, located in Malaysia, suggesting the testing was likely conducted in Malaysia. The studies are prospective as they are tests performed on the Lovytex device to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics of examination gloves is established by standardized testing protocols (e.g., ASTM standards, FDA pinhole requirements) and general biocompatibility assessments, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective laboratory measurements against set standards, not by an adjudication process involving human review of cases.
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 diagnostic devices that involve human interpretation of images or other data. For examination gloves, the focus is on material properties and barrier integrity, not diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted are standalone evaluations of the device's physical and biological properties. There is no "algorithm" or human-in-the-loop component for examination gloves. The device's performance is assessed purely on its inherent characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Standardized Test Methods: Adherence to established industry standards like ASTM D 3578-95 for physical properties (e.g., tensile strength, elongation).
- Regulatory Requirements: Meeting FDA specific requirements, such as pinhole acceptance rates.
- Biocompatibility Testing: Results from established biological evaluation methods for medical devices (e.g., cytotoxicity tests, skin irritation tests).
8. The Sample Size for the Training Set
This concept is not applicable here. There is no "training set" for physical and biocompatibility testing of examination gloves as there is no machine learning or AI algorithm being developed. The tests are performed on representative samples of the manufactured gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved in this type of device 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.