(48 days)
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs.
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document, K092327, details the 510(k) summary for Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use). This is a submission for a medical device (examination gloves), which typically uses performance standards and bench testing rather than clinical studies with human participants or AI algorithms. As such, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, adjudication methods) are not applicable to this type of submission.
Here's a breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) - Standard Specification for Nitrile Examination Gloves for Medical Application (Implicitly, the dimensional requirements within this standard) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) - Standard Specification for Nitrile Examination Gloves for Medical Application (Implicitly, tensile strength, elongation, etc.) | Meets |
| Freedom from Holes / Holes | ASTM D 6319-00a(2005) (General requirement) and ASTM D 5151-06 (Specific test method for freedom from holes) | Meets |
| Powder-Free | ASTM D 6124-06 (Standard test method for residual powder on medical gloves) | ≤2 mg per glove (meets the standard's requirements for powder-free) |
| Biocompatibility | ISO Skin Irritation Study | Passes |
| ISO Maximization Sensitization Study | Passes | |
| Extract Cytotoxicity Study Using the End-Point Titration Method | Non-toxic at 24 hours for dilutions 1:2 through 1:32 | |
| Chemotherapy Drug Permeation Test | ASTM D 6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Chemotherapy Drug Permeation (average breakthrough time in minutes): |
- Carmustine: 45.27
- Cyclophosphamide: >240
- Doxorubicin Hydrochloride: >240
- Etoposide (Toposar): >240
- 5-Fluorouracil: >240
- Paclitaxel (Toxol): >240
- Thio-Tepa: 93.50
- Vincristine Sulfate: >240
- Methotrexate: >240 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance data based on adherence to ASTM and ISO standards for examination gloves. These tests typically involve statistical sampling from manufacturing lots according to the respective standard's requirements. The document does not specify the exact sample sizes used for each test or the data provenance (e.g., country of origin) beyond stating these are "non-clinical tests." The nature of these tests (e.g., physical property testing, chemical permeation) means samples are taken from product batches, not human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for glove performance characteristics is established by objective measurements against recognized industry standards (ASTM, ISO) and laboratory testing, not by expert consensus on clinical or imaging data.
4. Adjudication Method for the Test Set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is irrelevant for objective physical and chemical property testing of examination gloves.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These studies are typically used to evaluate the impact of AI on human reader performance for tasks like image interpretation, which 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 device is an physical examination glove, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" is based on objective measurements against established performance standards and test methodologies (e.g., ASTM D 6319-00a(2005) for dimensions and physical properties, ASTM D 5151-06 for holes, ASTM D 6124-06 for powder, ISO studies for biocompatibility, and ASTM D 6978-05 for chemotherapy drug permeation).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set. The performance data is derived from testing physical product samples.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device like examination gloves.
§ 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.