(42 days)
The powder free vinyl patient examination glove (non-sterile) 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. It is sold as non-sterile.
Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves (Non-Sterile):
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Our Device) |
|---|---|---|
| Dimension | Meets ASTM D 5250-06 | Meets ASTM D 5250-06 |
| Physical Properties | Meets ASTM D 5250-06 | Meets ASTM D 5250-06 |
| Freedom from pinholes | Meets 21 CFR 800.20 (Predicate) / ASTM D5151-06 (Our Device's stated standard) | Meets ASTM D5151-06 |
| Powder Residual | Meets ASTM D6124-06 (Predicate) / ASTM D5250-06 and D6124-06 (Our Device's stated standard) | Meets ASTM D5250-06 and D6124-06 |
| Biocompatibility | Passes (for Primary Dermal Irritation) | Passes |
| Biocompatibility | Passes (for Guinea Pig Closed Patch Sensitization Test) | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting ASTM standards (D 5250-06, D5151-06, D6124-06) for physical properties, dimensions, freedom from pinholes, and powder residual. These standards typically define sampling plans and test methods.
For biocompatibility testing:
- Primary Dermal Irritation in Rabbits (ISO): The number of rabbits used is not explicitly stated, but ISO standards for dermal irritation typically involve a small number of animals (e.g., 3 rabbits).
- Guinea Pig Closed Patch Sensitization Test (ISO): The number of guinea pigs used is not explicitly stated, but ISO standards for sensitization testing typically involve a defined number of animals (e.g., 10-20 guinea pigs for the induction phase and a similar number for the challenge phase).
Data Provenance: The studies were conducted by the applicant, LPL (Hui Zhou) Glove Co., Ltd. The country of origin for the data is implied to be China, where the company is located. The studies are prospective as they were conducted to demonstrate the performance of the applicant's device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device (patient examination gloves) does not involve a diagnostic algorithm requiring expert-established ground truth. The evaluation relies on standardized physical, chemical, and biological testing.
4. Adjudication Method for the Test Set:
Not applicable. No expert adjudication was performed as the evaluation is based on objective measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a physical product (gloves) and does not involve AI or human interpretation of cases. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for the performance evaluations (Dimensions, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility) is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standards: ASTM D 5250-06, ASTM D5151-06, ASTM D6124-06. These standards define the test methods, acceptance limits, and sampling plans for the respective characteristics.
- Regulatory Standard: 21 CFR 800.20 (for freedom from pinholes, as referenced for the predicate device).
- ISO Standards: For biocompatibility testing (Primary Dermal Irritation and Guinea Pig Closed Patch Sensitization Test), implying adherence to ISO biological evaluation standards.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #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.