(42 days)
Powder Free Blue Patient Nitrile Examination Gloves 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.
Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria for the "Powder Free Blue Patient Nitrile Examination Gloves" and the study that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 6139-05 | Meets |
| Physical Properties | ASTM D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-00c4 and D6124-01 | Meets |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in guinea pig (ISO10993-10) | Passes (Not a Dermal sensitization) |
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. However, the testing was conducted on the "Powder Free Blue Patient Nitrile Examination Gloves" manufactured by Tangshan Luxiong Plastic Products Co.,Ltd. The data provenance is not specified as retrospective or prospective, but it can be inferred that the testing was conducted specifically for this device as part of its premarket notification process. The country of origin of the device is China.
3. Number of Experts and their Qualifications for Ground Truth
The concept of "experts" and "ground truth" as typically applied to AI/ML device studies (e.g., radiologist consensus) is not directly applicable here. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards. Therefore, the "ground truth" is defined by these standards, and the "experts" would be the certified laboratories and personnel conducting the specified tests according to the standard operating procedures of each test. Their qualifications would be their certification and experience in performing these specific tests (e.g., in material science testing, biological safety testing).
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not applicable to the testing of medical gloves against performance standards. The results of the tests (e.g., whether a dimension meets the specification, whether a sample passes the pinhole test) are objective measurements or categorical outcomes that do not require human interpretation or consensus in the same way as an image diagnosis. The "adjudication" is inherent in the methodology of the standard test itself, where specific pass/fail criteria are defined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted medical devices where human readers interpret medical images or data. The "Powder Free Blue Patient Nitrile Examination Gloves" is a physical barrier device, and its effectiveness is determined by its physical and biological properties.
6. Standalone Performance (Algorithm Only)
A standalone performance study (algorithm only) was not done. This device is not an algorithm or AI system. Its performance is entirely physical and biological, as assessed through laboratory testing.
7. Type of Ground Truth Used
The type of ground truth used is based on established industry standards and regulatory requirements. Specifically:
- ASTM D 6139-05: For Dimension and Physical Properties.
- 21 CFR 800.20: For Freedom from pinholes.
- ASTM D 5250-00c4 and D6124-01: For Powder Residual.
- ISO10993-10: For Biocompatibility (Primary Skin Irritation and Dermal sensitization).
These standards define the methodologies, acceptance criteria, and expected performance for patient examination gloves.
8. Sample Size for the Training Set
A "training set" is not applicable to this device. This is not an AI/ML device that requires machine learning model training. The device's manufacturing process is controlled to meet the specified standards, and batches are tested to ensure compliance.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set is not relevant here. The "ground truth" for the device's performance is inherently defined by the objective, predetermined pass/fail criteria within the ASTM and ISO standards mentioned above. These standards are developed through expert consensus within their respective organizations (ASTM, ISO) and are widely accepted in the industry and by regulatory bodies.
§ 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.