(84 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 patient.
Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are Violet, Blue, Green or Pink colored.
The provided text describes a 510(k) summary for AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES. This document is a regulatory filing for a medical device and, as such, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific performance criteria in the way a diagnostic algorithm or drug might.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of document. However, I can extract the relevant information where it exists and state explicitly when certain information is not provided.
Here is an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM D 3578-99 and 21 CFR 800.20) | Reported Device Performance |
|---|---|
| Physical Properties (per ASTM D 3578-99 standard) | "Gloves meet all the current specifications listed under the ASTM specifications D 3578-99 standard specification for latex examination gloves." (Specific metrics like tensile strength, elongation, dimensions, etc., are not detailed but are implied to be met by this statement.) |
| Freedom from Holes (AQL for pinholes, per ASTM D 3578-99 and 21 CFR 800.20) | Implied to be met by "Gloves meet all the current specifications listed under the ASTM specifications D 3578-99 standard specification for latex examination gloves" and regulatory compliance. (Specific AQL levels not stated) |
| Protein Content (specific to the protein claim) | "AMBIDERM Powder Free Latex Examination Gloves with Protein Labeling Claim... [with] Protein Claims of 50 Micrograms or Less Per Grams." |
| Biocompatibility - Primary Skin Irritation | "Primary skin irritation testing in the rabbit... indicate no irritation." |
| Biocompatibility - Delayed Contact Sensitization | "delayed contact sensitization testing in the guinea pig indicate no... sensitization." |
| Absence of Starch (USP Iodine test) | "Final product is negative for the test for presence of starch using the USP Iodine test." |
Note: The document states that the device is "substantially equivalent to the Class I patient examination glove 80LYY" and "meets all the current spec listed under the ASTM specification D 3578-99 standard specification for rubber examination gloves." This implies that the acceptance criteria are those defined in the ASTM standard and relevant FDA regulations for patient examination gloves. Specific numerical values for the performance criteria (e.g., tensile strength minimums, AQL levels) are not enumerated in this summary but would be detailed in the full ASTM standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "nonclinical tests."
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for these nonclinical tests is not specified beyond noting they were performed internally via ASTM D 3578-99 and 21 CFR 800.20 methodologies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards for physical properties, USP tests for chemical properties, animal models for biocompatibility), not by expert consensus on specific cases.
4. Adjudication Method for the Test Set
This concept is not applicable for the type of device and testing described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or diagnoses, not for performance testing of a physical product like an examination glove.
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 outputs (e.g., radiologists reading images) and assessing the impact of AI assistance. This device is a physical examination glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Test Specifications: Adherence to ASTM D 3578-99 for physical properties.
- Biocompatibility Testing: Results from established animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization).
- Chemical Tests: USP Iodine test for starch.
- Protein Content Measurement: Specific laboratory methods to quantify protein according to the stated claim (though the specific measurement method isn't detailed, it's implied by the protein claim).
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.