(36 days)
AMBIDERM Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.
Ambiderm Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are either Violet, Blue, Green or Pink colour.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES are explicitly stated by referencing industry standards. The device's performance is reported as meeting these standards.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Material Specifications: | |
| ASTM Specification D 3578-99 Standard Specification for Rubber Examination Gloves | Gloves meet all current specifications listed under ASTM Specification D 3578-99. |
| Biocompatibility: | |
| Primary skin irritation testing (rabbit) | No irritation. |
| Delayed contact sensitization testing (guinea pig) | No sensitization. |
| Presence of Starch: | |
| USP iodine test for starch presence | Negative for the test. |
| Protein Content: | |
| 50 microgram or less of total water extractable protein per gram (as per 510(k) confirmation letter) | Contains 50 microgram or less of total water extractable protein per gram. |
| General Controls Provisions (as per FDA letter): | Compliance with annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for tensile strength, or how many rabbits/guinea pigs were used for biocompatibility). However, it implies that the testing was performed "as per ASTM D 3578-99 and 21 CFR 800.20," meaning the sample sizes and testing methodologies would follow those standards.
- Data Provenance: The tests are non-clinical (laboratory and animal data). The country of origin for the data is not specified, but the submission is to the FDA in the USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the evaluation of this device. The "ground truth" for glove performance is established by standardized testing protocols (ASTM D 3578-99) and regulatory requirements (21 CFR 800.20). Expert interpretation of images or clinical outcomes, which typically requires multiple experts and their qualifications, is not relevant for this product.
4. Adjudication Method for the Test Set
Not applicable. The tests involve quantifiable measurements against established standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device clearance for examination gloves. MRMC studies are typically performed for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. This type of study is not relevant for examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device. Performance tests were conducted on the physical product.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements.
- Industry Standards: ASTM Specification D 3578-99 for physical properties (e.g., dimensions, physical integrity, tensile strength) which dictate acceptable ranges for these characteristics.
- Regulatory Standards: 21 CFR 800.20 for biological safety (biocompatibility).
- Specific Claims: The claim of "50 microgram or less of total water extractable protein per gram" is also a specific performance metric.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is evaluated through direct physical and biological testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.