(87 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.
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 six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.
The provided document is a 510(k) premarket notification for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs). It details the device's technical characteristics, intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The core performance evaluation for these gloves relates to their physical properties, freedom from holes, powder content, biocompatibility, and most importantly, resistance to permeation by chemotherapy drugs.
| Test Method | Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | ||
| Length (mm) - XS | ≥220 | > 240/Pass | |
| Length (mm) - S/M/L/XL/XXL | ≥230 | > 240/Pass | |
| Width (mm) - XS | 70 ± 10 | 67-72/Pass | |
| Width (mm) - S | 80 ± 10 | 76-83/Pass | |
| Width (mm) - M | 95 ± 10 | 91-99/Pass | |
| Width (mm) - L | 110 ± 10 | 106-112/Pass | |
| Width (mm) - XL | 120 ± 10 | 116-124/Pass | |
| Width (mm) - XXL | 130 ± 10 | 127-134/Pass | |
| Thickness (mm) - Finger | ≥0.05 | 0.06-0.10/Pass | |
| Thickness (mm) - Palm | ≥0.05 | 0.07-0.10/Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 holes out of 125 gloves tested, meeting or exceeding AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 ≤ 2.0mg | 0.02mg/Pass |
| ASTM D412 | Physical Properties (Tensile Strength & Elongation) | ||
| Before Aging: | |||
| Tensile Strength | ≥14MPa | 16.4-17.8MPa/Pass | |
| Ultimate Elongation | ≥500% | 533-551%/Pass | |
| After Aging: | |||
| Tensile Strength | ≥14MPa | 15.8-16.8MPa/Pass | |
| Ultimate Elongation | ≥400% | 520-554%/Pass | |
| ISO 10993-5 | Biocompatibility - Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of the study, device extract is not cytotoxic. /Pass |
| ISO 10993-10 | Biocompatibility - Irritation | Non-irritating | Under the conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Biocompatibility - Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| **ASTM D6978-05 (Reapproved 2019) ** | Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time) | ||
| Carboplatin (10.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| Carmustine (BCNU) (3.3 mg/ml) | N/A (Comparative to predicate) | 35.2 Minutes | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| Doxorubicin (2.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| Etoposide (20.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| Fluorouracil (50.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| Methotrexate (25.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| Paclitaxel (6.0 mg/ml) | N/A (Comparative to predicate) | > 240 Minutes | |
| ThioTepa (10.0 mg/ml) | N/A (Comparative to predicate) | 76.3 Minutes |
Note on Chemotherapy Permeation Acceptance Criteria: The document primarily presents these as reported values and compares them to the predicate device in Table 1 (pages 6-7). The acceptance criteria for these would implicitly be that the breakthrough times are considered sufficient for safe use, or comparable/better than the predicate for equivalent drugs, with a clear warning for drugs with low permeation times. The "Warning: Please do not use with Carmustine (BCNU) and ThioTepa" indicates that the low breakthrough times for these specific drugs are accepted with a cautionary label, rather than requiring an explicit "minimum time" acceptance criterion for regulatory clearance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the total sample size for all tests performed. However, it does provide a specific sample size for one critical test:
- Watertightness Test (ASTM D5151): 125 gloves were tested (indicated by "0/125/Pass").
- For other tests (e.g., physical dimensions, tensile strength, powder content, biocompatibility, chemotherapy permeation), the specific number of gloves or samples tested is not explicitly stated in the provided summary, although the ASTM standards themselves would specify statistical sampling plans.
- Data Provenance: The tests were conducted by the manufacturer, Yunnan Huazhiyuan Medical Technology Co., Ltd. The location is China. The studies are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance with standards for the 510(k) submission, rather than being part of a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to this type of device and submission. The "ground truth" for the performance of these medical gloves is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, chemical resistance, and biocompatibility, as measured by laboratory equipment and procedures, not by expert human interpretation or consensus. No human "experts" are interpreting images or clinical data for this non-diagnostic device.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly in imaging or diagnostic device evaluations where multiple readers interpret data and discrepancies need to be resolved. For laboratory bench testing against physical and chemical standards, there is no human interpretation needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This section is not applicable. MRMC studies are specific to diagnostic devices, especially those involving image interpretation by multiple human readers, to assess the impact of an AI algorithm on reader performance. This device is a medical glove, a Class I non-diagnostic device, and its performance is evaluated through bench testing against established standards, not human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This device is not an algorithm or AI-based product. Its performance is entirely standalone in the sense that its physical and chemical properties are measured directly from the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based entirely on laboratory bench testing results measured against predefined acceptance criteria established by recognized international standards (ASTM and ISO).
- Physical properties: Measured dimensions, tensile strength, elongation.
- Freedom from holes: Tested using a water-tightness test.
- Powder content: Measured residual powder.
- Biocompatibility: In vitro cytotoxicity, irritation, and sensitization tests.
- Chemotherapy drug permeation: Measured breakthrough times using specific chemical assays as per ASTM D6978-05.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for the device's manufacturing process would be based on quality control and manufacturing specifications, not a data training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as it pertains to AI/ML devices.
§ 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.