(111 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® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs meet all of the current specifications of ASTM D6319-00a(2005)e1, Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance of "Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs" as part of a 510(k) submission (K093523).
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| General Glove Standards | ||
| Dimensions | ASTM D 6319-00a(2005)e1 | Meets |
| Physical Properties | ASTM D 6319-00a(2005)e1 | Meets |
| Freedom from Holes | ASTM D 6319-00a(2005)e1 & ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤2 mg per glove |
| Biocompatibility | ||
| Primary Skin Irritation | Animal Study | Passes |
| Dermal Sensitization Assay | Animal Study | Passes |
| Chemotherapy Drug Permeation (ASTM D6978-05) | ||
| Carmustine | Not explicitly stated as a minimum, but breakthrough time recorded | 12.4 minutes |
| Cyclophosphamide | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
| Doxorubicin Hydrochloride | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
| Etoposide (Toposar) | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
| 5-Fluorouracil | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
| Paclitaxel (Toxol) | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
| ThioTEPA | Not explicitly stated as a minimum, but breakthrough time recorded | 19.6 minutes |
| Cisplatin | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
| Dacarbazine | Not explicitly stated as a minimum, but breakthrough time recorded | >240 minutes |
Note on Chemotherapy Drug Permeation Acceptance Criteria: While specific minimum breakthrough times are not explicitly listed as "acceptance criteria" in the table within the document, the "Indications for Use" section presents these values as the performance data for which the device was "tested for use." The underlying acceptance criterion for these drugs would be defined by the ASTM D6978-05 standard for acceptable permeation, likely implying a desired "resistant" or "protective" duration, which the ">240 minutes" results aim to demonstrate. The WARNING regarding Carmustine and ThioTEPA with their lower breakthrough times indicates that these specific drugs do not meet an acceptable level of protection, hence the cautionary instruction.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of gloves tested) for each of the performance tests (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Biocompatibility, and Chemotherapy Drug Permeation). It only reports the performance results based on standard test methods.
The data provenance is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective. However, given that this is a 510(k) submission for a new device, the testing would generally be considered prospective in nature, performed specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a "ground truth" in the context of interpretation or diagnosis for this device. This product is a physical device (examination gloves), and its performance is evaluated through standardized laboratory tests, not through expert review of clinical images or data. Therefore, the concept of qualified experts establishing ground truth for a test set is not applicable here.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance of the gloves is based on objective laboratory measurements and adherence to ASTM standards, not on subjective assessment requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an imaging or diagnostic device that would typically involve human readers or MRMC studies. The device is a medical glove, and its effectiveness is determined by its physical and chemical barrier properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The testing performed for the gloves is entirely "standalone" in that it evaluates the intrinsic properties of the device itself (e.g., integrity, dimensions, chemical resistance) without human interaction or a "human-in-the-loop" component for its functional assessment. There is no algorithm involved.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Standardized Test Methods and Specifications: Adherence to defined ASTM standards (e.g., ASTM D 6319-00a(2005)e1 for dimensions and physical properties, ASTM D 5151-06 for freedom from holes, ASTM D 6124-06 for powder residue, and ASTM D6978-05 for chemotherapy drug permeation).
- Established Biological Safety Standards: Demonstrated biocompatibility through "Animal Study" results (Primary Skin Irritation and Dermal Sensitization Assay).
These standards and test results serve as the objective "truth" against which the device's performance is measured.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm or a diagnostic system that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.