(64 days)
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Here's a breakdown of the acceptance criteria and study information for the "POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Physical Properties | |
| Tensile Strength (Unaged) | 21.0 MPa (Minimum 14 MPa) |
| Tensile Strength (Aged) | 18.2 MPa (Minimum 14 MPa) |
| Elongation at Break (Unaged) | 600% (Minimum 500%) |
| Elongation at Break (Aged) | 500% (Minimum 400%) |
| Barrier Integrity | |
| Freedom from Holes (AQL 2.5) | AQL 2.5 |
| Biocompatibility | |
| Dermal Sensitization | Non-sensitizing |
| Primary Skin Irritation | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the "test set." However, it references established industry standards:
- Tensile Strength & Elongation: Tested according to ASTM D412.
- Freedom from Holes: Tested according to ASTM D5151 (Water Leak Test) and FDA 21 CFR 800.20 (Acceptance Quality Limit - AQL). The AQL of 2.5 implies a sampling plan based on lot size, which dictates the number of units to be inspected and the maximum allowable number of failures.
- Biocompatibility: Tested according to ISO 10993-10 (Dermal Sensitization and Primary Skin Irritation).
The data provenance is not explicitly stated in terms of country of origin for the performance tests, but the manufacturer is "Comfort Rubber Gloves IND. SDN. BHD." from Malaysia. The tests are prospective in nature, as they are performed on the device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests is established by objective, standardized measurements and laboratory assessments, not by expert consensus or interpretation of images. For example, tensile strength is measured quantitatively, and freedom from holes is determined by a physical water leak test.
4. Adjudication Method for the Test Set
This information is not applicable. The performance criteria for patient examination gloves are based on objective physical and chemical testing, not on adjudicated readings or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not applicable and therefore not done. This type of study is relevant to AI/diagnostic imaging devices where human readers interpret data, and the AI's impact on their performance is evaluated. This device is a physical medical device (examination glove), and its performance is assessed through standardized laboratory tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical product, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on:
- Objective physical measurements: For tensile strength and elongation.
- Adherence to established quality limits: For freedom from holes (AQL 2.5).
- Standardized laboratory biological assays: For dermal sensitization and primary skin irritation (ISO 10993-10).
Essentially, the "ground truth" is defined by the performance requirements outlined in the relevant ASTM, FDA, and ISO standards that the device must meet.
8. The Sample Size for the Training Set
This information is not applicable. The device is a manufactured product, not an AI model that requires a "training set." Its performance is directly assessed through testing of manufactured samples.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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.