(91 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 qloves are offered in four sizes: extra-small, small, medium, large, and extra-large.
This document describes the premarket notification (510(k)) for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs). The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K190860). The "device" in this context refers to the Nitrile Examination Gloves. The acceptance criteria and the study that proves the device meets them are based on non-clinical (bench) testing, as no clinical testing was performed or required for this device type.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally defined by compliance with specific ASTM and ISO standards, and the reported performance are the test results demonstrating this compliance.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| ISO 10993-10:2010 (Irritation & Sensitization) | Assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation, or skin sensitization. | Skin Sensitization Test: Provided grades less than 1, otherwise sensitization. | |
| Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | Skin Sensitization Test: All grades are 0. All animals survived and no abnormal signs were observed. | ||
| Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible. | |||
| ISO 10993-5:2009 (Cytotoxicity) | Describes test methods to assess the in vitro cytotoxicity of medical devices. | The viability (%) of the 100% extract of the test article is the final result, and if viability is reduced to 15.1 Minutes | |
| Cisplatin 1.0 mg/ml: > 240 Minutes | |||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Carboplatin 10.0 mg/ml: > 240 Minutes | |||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | |||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | |||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||
| Thio Tepa 10.0 mg/ml: > 32.8 Minutes | Carmustine (BCNU) 3.3 mg/ml: 15.1 minutes (individual results: 15.1, 16.4, 16.6) | ||
| Cisplatin 1.0 mg/ml: > 240 Minutes | |||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Carboplatin 10.0 mg/ml: > 240 Minutes | |||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | |||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | |||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||
| Thio Tepa 10.0 mg/ml: 32.8 minutes (individual results: 48.6, 32.8, 46.1) | |||
| (Note: A warning is included for Carmustine (BCNU) and Thiotepa due to low permeation times.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Freedom from Holes (ASTM D5151-19): 125 gloves.
- Chemotherapy Drug Permeation (ASTM D6978-05): The table provides individual breakthrough detection times for some drugs, indicating multiple samples were tested (e.g., three reported times for Carmustine and Thio Tepa). Specific sample sizes for each drug are not explicitly stated beyond these examples.
- Other tests (Biocompatibility, Physical Properties, Residual Powder): Specific sample sizes are not detailed in the provided text, but testing was conducted "in accordance with" the listed standards, implying standard-appropriate sample sizes were used.
- Data Provenance: This is a 510(k) submission for a medical device (nitrile examination gloves). The testing is non-clinical (bench testing), meaning it was performed in a laboratory setting to assess the physical and chemical properties of the gloves. The country of origin of the data is not explicitly stated for each test, but the submitting company is 5R MED Instruments (CHENGDU) Co., Ltd. located in China. The testing would have been conducted in a controlled lab environment. The studies are prospective tests performed on the manufactured device to ensure it meets the required standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For a device like examination gloves, "ground truth" is established by laboratory measurements against defined standards (e.g., strength, thickness, permeation time), not by expert human interpretation of medical images or clinical outcomes. The tests are objective, quantifiable measurements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (like medical images) and their discrepancies need to be resolved. For non-clinical bench testing, the results are quantitative and directly measured by calibrated equipment and documented procedures.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are used to evaluate the diagnostic performance of medical imaging devices, often comparing human readers with and without AI assistance. This submission is for examination gloves, which do not involve such diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. "Standalone performance" typically refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. Its performance is demonstrated through physical and chemical property testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective, measurable physical properties and chemical resistance, defined by international standards:
- Standard-defined thresholds: For properties like tensile strength, elongation, freedom from holes (AQL), residual powder, dimensions (length, width, thickness), and breakthrough times for chemotherapy drugs.
- Laboratory measurements: Results obtained from standardized test methods (ASTM, ISO).
- Biocompatibility assessments: Based on established criteria for irritation, sensitization, and cytotoxicity from biological assays.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model. There is no "training set" in the context of examination gloves.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it. The ground truth for the device's performance is based on its physical, chemical, and biological properties measured against established standards during non-clinical testing.
§ 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.