(72 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
The provided document is a 510(k) summary for a medical device: "Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)". It details the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on your requested format:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | ||
| Length (mm) | XS/S: ≥220; M/L/XL: ≥230 | All reported lengths were >230 mm (Pass) | |
| Width (mm) | XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | All reported widths for three lots were within specified ranges (Pass) | |
| Thickness (mm): Finger | ≥0.05 | All reported finger thicknesses for three lots were ≥0.08 mm (Pass) | |
| Thickness (mm): Palm | ≥0.05 | All reported palm thicknesses for three lots were ≥0.08 mm (Pass) | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks; S: 1/125 leaks; M: 0/125 leaks; L: 0/125 leaks; XL: 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 240 Minutes | |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Dacarbazine (DTIC) 10.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Doxorubicin HCl 2.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Etoposide 20.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Fluorouracil 50.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Methotrexate 25 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Mitomycin C 0.5 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Paclitaxel 6.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Thio Tepa 10.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Note: Predicate had 43.7 min, Subject has 44.2 min for this drug) | 44.2 Minutes (Caution: Testing showed an average breakthrough time of 44.2 minutes with Thio-Tepa) | |
| Vincristine Sulfate 1.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
2. Sample size used for the test set and the data provenance
- ASTM D6319 (Physical Dimensions, Tensile Strength, Ultimate Elongation): Data is reported for "Lot 1", "Lot 2", and "Lot 3". Each lot appears to represent multiple measurements across different sizes (XS, S, M, L, XL). The exact sample size per lot or per measurement (e.g., how many gloves were measured for length, width, thickness, or subjected to tensile tests) is not explicitly stated, but it follows the standard ASTM D6319 requirements for quality assurance.
- ASTM D5151 (Watertightness): The sample sizes are explicitly stated as 125 gloves per size: XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks, L: 0/125 leaks, XL: 0/125 leaks.
- ASTM D6124 (Powder Content): The sample size for powder content is not explicitly stated.
- ASTM D6978 (Chemotherapy Drug Permeation): The sample size for each drug test is not explicitly stated in the provided text.
- ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization): The sample sizes used for these biocompatibility tests are not explicitly stated, but the tests were conducted "under conditions of the study" which implies adherence to the standard's methodology.
- Data Provenance: All testing appears to be non-clinical (bench testing and laboratory biocompatibility tests). There is no information provided about patient data or country of origin for such data, as this is a device for which clinical testing was not deemed necessary. The testing was conducted in support of a device manufactured by Jiangsu Cureguard Glove Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" in this context is established by standardized physical, chemical, and biological testing methods (ASTM and ISO standards), not by individual expert consensus or interpretation of medical images. The results are objective measurements.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements against predefined acceptance criteria from international standards. There is no element of subjective assessment requiring adjudication in the context of these non-clinical tests.
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
Not applicable. This device is a medical examination glove, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove and does not involve any algorithm or AI component.
7. The type of ground truth used
The ground truth used for performance validation is based on standardized test methods and their defined performance criteria. Specifically:
- ASTM Standards: ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ASTM D6978 (chemotherapy drug permeation). These standards define the procedures for measurement and the expected acceptable ranges or thresholds.
- ISO Standards (Biocompatibility): ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These standards define the methods and parameters for assessing the biological safety of the device.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.