(93 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.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.7 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | 240 Minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | 240 Minutes |
| Methotrexate | 25 mg/ml(25,000 ppm) | 240 Minutes |
| Mitomycin C | 0.5 mg/ml(500 ppm) | 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | 240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 45.7 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes
Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa
WARNING: Do not use with Carmustine
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 non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.
Below is a summary of the acceptance criteria and the study conducted for the Disposable Nitrile Examination Glove, as detailed in the provided FDA 510(k) submission.
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 | |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | |||
| Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: >230 mm for all sizes | ||
| Width: XS: 75-80; S: 85-87; M: 95-98; L: 105-107; XL: 115-117 | |||
| Thickness (mm): XS Finger: 0.10 | |||
| Result: 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: 2/125 leaks; XL: 2/125 leaks |
| Result: Pass | |||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 240 Minutes | |
| Cyclophosphamide (Cytoxan): > 240 Minutes | |||
| Dacarbazine (DTIC): > 240 Minutes | |||
| Doxorubicin HCl: > 240 Minutes | |||
| Etoposide: > 240 Minutes | |||
| Fluorouracil: > 240 Minutes | |||
| Methotrexate: > 240 Minutes | |||
| Mitomycin C: > 240 Minutes | |||
| Paclitaxel: > 240 Minutes | |||
| Thio Tepa: 45.7 Minutes | |||
| Vincristine Sulfate: > 240 Minutes | |||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. |
| Result: Pass | |||
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. |
| Result: Pass | |||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. |
| Result: Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides sample sizes for specific tests:
- ASTM D5151 (Watertightness): 125 gloves per size (XS, S, M, L, XL) were tested.
- The specific sample sizes for other tests like physical dimensions (ASTM D6319, ASTM D412), powder content (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993-5, ISO 10993-10) are not explicitly stated in numerical terms (e.g., "n=X"), but are implied to be sufficient to meet the requirements of the respective ASTM and ISO standards.
- Data Provenance: The studies were conducted by the device manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is located in China. The data would be considered prospective as it involves new testing on the subject device to demonstrate its performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this device. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., ASTM and ISO methods) rather than expert clinical judgment or consensus. These are physical and chemical properties measured according to specific protocols.
4. Adjudication Method for the Test Set:
This is not applicable to this device. As mentioned above, the evaluation relies on objective measurements from standardized test methods, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or other complex data, and their performance is compared with and without AI assistance. Examination gloves are a Class I device with performance assessed via bench testing, not human interpretation.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination glove), not an AI algorithm or software. Its performance is evaluated through material and physical property testing, not algorithmic output.
7. Type of Ground Truth Used:
The ground truth used in these studies is based on objective, quantitative measurements obtained through validated and standardized laboratory test methods as defined by:
- ASTM International (formerly American Society for Testing and Materials) standards: ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978.
- ISO (International Organization for Standardization) standards: ISO 10993-5 and ISO 10993-10.
These standards define the methods for measuring physical properties, chemical resistance, and biocompatibility, and the "ground truth" is the result of these measurements compared against the specified acceptance criteria within the standard.
8. Sample Size for the Training Set:
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" of data. The manufacturing process of examination gloves is based on established engineering principles and quality control, rather than machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This information is 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.