(134 days)
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).
This document is a 510(k) Premarket Notification for Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs). As such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on the performance of an AI/ML powered medical device. Therefore, a significant portion of the requested information (points 2-5, 7-9) about the study design for an AI/ML powered device is not applicable to this document.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The device meets acceptance criteria across several tests, primarily based on ASTM standards.
| Test Standard Followed | Test Conducted | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions - Length (mm) | ≥220 | Pass | Pass |
| ASTM D6319-19 | Physical Dimensions - Width (mm) | S: 80±10, M: 95±10, L: 110±10, XL: 120±10 | Pass | Pass |
| ASTM D6319-19 | Physical Dimensions - Thickness (Finger & Palm) | ≥0.05 mm | Pass | Pass |
| ASTM D6319-19 | Physical Properties - Before Aging | Tensile ≥14Mpa; Elongation ≥500% | Pass | Pass |
| ASTM D6319-19 | Physical Properties - After Aging | Tensile ≥14Mpa; Elongation ≥400% | Pass | Pass |
| ASTM D6319-19 & ASTM D5151-19 | Watertightness Test for detection of holes | Batch size=35000, sample 125, ≤7 defective gloves (AQL 1.5) | Pass | Pass |
| ASTM D6319-19 & ASTM D6124-06 (2017) | Powder Residual | ≤2 (mg/glove) | Pass | Pass |
| ASTM D6978-05(2019) | Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time | Specific breakthrough times for various chemotherapy drugs, generally >240 min, except for Carmustine (BCNU) where a specific time is given, and a "Do Not Use" warning is issued. The acceptance criterion is implicit: the glove must perform as reported for safe use or be explicitly contraindicated for certain drugs based on the test results. | As reported in the table above and below (see section 9. Conclusion) | Pass for indicated drugs |
| ISO 10993-10 | Biocompatibility - Skin Irritation Test | non-irritation | Pass (non-irritation) | Pass |
| ISO 10993-10 | Biocompatibility - Skin Sensitization | non-sensitization | Pass (non-sensitization) | Pass |
| ISO 10993-11 | Biocompatibility - Acute Systemic Toxicity | non-acute systemic toxicity | Pass (non-acute systemic toxicity) | Pass |
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:
- For the Watertightness Test (detection of holes), the sample size was 125 gloves for a batch size of 35,000.
- For other physical and chemotherapy permeation tests, the specific sample sizes are not explicitly stated within the provided text, but they were conducted "per ASTM D6319-19" and "per ASTM D6978-05(2019)", implying adherence to the sample size requirements of those standards.
- Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the independent labs performing the tests are located) or whether the studies were retrospective or prospective, though performance testing is inherently prospective for a new device. The submitter is XINGYU MEDICAL TECH CO.,LTD. from China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. This document describes performance testing of medical gloves against established ASTM and ISO standards for physical properties, chemotherapy permeation, and biocompatibility. Ground truth in this context is determined by laboratory measurements and chemical/biological assays, not by expert interpretation of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As mentioned above, the assessment criteria are based on objective, standardized laboratory tests, not subjective expert judgment that would require an adjudication method.
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
This information is not applicable. This document is for medical gloves, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document is for medical gloves, not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and observations derived from standardized laboratory tests:
- Physical Measurements: Length, width, and thickness measured according to ASTM D6319-19.
- Mechanical Property Tests: Tensile strength and elongation measured before and after aging according to ASTM D6319-19.
- Watertightness Test: Detection of holes by visual inspection after inflation or water fill, according to ASTM D5151-19.
- Chemical Analysis: Residual powder measured according to ASTM D6124-06 (2017).
- Permeation Testing: Breakthrough time of chemotherapy drugs measured using a sensitive analytical method (e.g., gas chromatography, liquid chromatography) to detect the permeation of the drug through the glove material (as per ASTM D6978-05(2019)).
- Biocompatibility Assays: In-vitro or in-vivo tests to assess skin irritation (e.g., patch tests on animals or human volunteers), dermal sensitization (e.g., guinea pig maximization test), and acute systemic toxicity (e.g., intravenous or oral administration to animals), according to ISO 10993-10 and ISO 10993-11.
8. The sample size for the training set
This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set" or ground truth establishment for such a set.
§ 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.