(277 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound. non-sterile (as per 21 CFR 880.6250. Class I). The patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document is a 510(k) Premarket Notification from the FDA, evaluating a medical device for substantial equivalence to a legally marketed predicate device. The information provided heavily focuses on bench testing and comparison to standards, rather than clinical studies with human participants or AI-driven performance metrics typically found in software as a medical device (SaMD) clearances.
Therefore, many of the requested details, such as the use of a test set with ground truth established by experts, MRMC studies, or training set details for an AI model, are not applicable to this document. The "device" in this context is a physical product (nitrile examination gloves) and not an AI/ML software.
The acceptance criteria and performance are related to the physical and chemical properties of the gloves, not AI performance.
Here's an attempt to answer the questions based only on the provided text, noting where information is not applicable (N/A) or not present.
Acceptance Criteria and Device Performance for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established by adherence to various ASTM standards and 21 CFR regulations for physical and chemical properties, and specifically ASTM D6978-05 for chemotherapy drug permeation. The reported performance is the device's measured characteristics against these standards.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance | Comparison |
|---|---|---|---|
| Dimension | ASTM D6319-10 (Reapproved 2015) | ||
| Length | ≥230mm | Complies with ASTM D6319-10 (230mm min.) | Met |
| Width (X Small) | 70 ± 10 mm | Complies with ASTM D6319-10 (70±10 mm) | Met |
| Width (Small) | 80 ± 10 mm | Complies with ASTM D6319-10 (80±10 mm) | Met |
| Width (Medium) | 95 ± 10 mm | Complies with ASTM D6319-10 (95±10 mm) | Met |
| Width (Large) | 110 ± 10 mm | Complies with ASTM D6319-10 (110±10 mm) | Met |
| Width (X Large) | 120 ± 10 mm | Complies with ASTM D6319-10 (120±10 mm) | Met |
| Thickness - Finger tip | ≥0.05mm | Complies with ASTM D6319-10 (0.05mm min.) | Met |
| Thickness - Palm | ≥0.05mm | Complies with ASTM D6319-10 (0.05mm min.) | Met |
| Physical Properties | ASTM D6319-10 (Reapproved 2015) | ||
| Tensile strength (Before aging) | ≥14MPa | ≥14MPa | Met |
| Tensile strength (After aging) | ≥14MPa | ≥14MPa | Met |
| Elongated rate (Before aging) | ≥500% | ≥500% | Met |
| Elongated rate (After aging) | ≥400% | ≥400% | Met |
| Freedom from pinholes | 21 CFR 800.20, ASTM D6319-10 (Reapproved 2015), Test method: ASTM D5151-06 (Reapproved 2015) | Passed Standard Acceptance Criteria (AQL 2.5) | Met |
| Powder Residual | ASTM D6319-10 (Reapproved 2015), Test method: D6124-06 (Reaffirmation 2011) | 240 minutes. | Met (except for stated exceptions) |
| Carmustine (BCNU) (3.3 mg/ml) | N/A (Comparative, less than 240 mins expected) | 59.4 minutes | N/A |
| Thiotepa (10.0 mg/ml) | N/A (Comparative, less than 240 mins expected) | 118.5 minutes | N/A |
| Most other 34 chemotherapy drugs | > 240 minutes | > 240 minutes | Met |
Note: For Carmustine and Thiotepa, the "acceptance criteria" is not explicitly defined as a threshold, but rather it is noted that these drugs have "extremely low permeation time," and the observed times are reported. The comparison is against the predicate device's performance for these specific drugs, which the proposed device improved upon (59.4 vs 12.4 for Carmustine, 118.5 vs 24.4 for Thiotepa).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample sizes for each specific test (e.g., how many gloves were tested for pinholes, or how many samples for each chemotherapy drug). It references adherence to ASTM standards, which would dictate appropriate sample sizes for these types of bench tests.
- Data Provenance: The tests were conducted to evaluate the qualities of the "Disposable Powder Free Nitrile Examination Glove, Blue Color" manufactured by Ever Growth (Vietnam) Co. Ltd. (Vietnam). These are bench tests on manufactured products, not data from human subjects or collected retrospectively/prospectively in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. The "ground truth" for the performance of these gloves is established by objective, standardized bench testing methods (e.g., ASTM standards for material properties, chemical permeation tests). There is no "expert consensus" or human adjudication involved in determining these physical and chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is applicable as these are objective bench test measurements, not subjective human interpretations that require reconciliation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This device is a physical medical glove, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- N/A. This device is a physical medical glove. "Standalone performance" in the context of an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance is determined by objective measurements obtained through standardized bench testing methods (e.g., ASTM International standards for physical properties, chemical permeation analysis). For example, a "pinhole" is objectively detected using a water leak test, and "tensile strength" is measured mechanically.
8. The sample size for the training set
- N/A. This is a physical device, not an AI/ML model for which a "training set" would be used.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for a physical product.
§ 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.