(70 days)
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10(2015) and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2013).
This document is a 510(k) summary for the "Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". It describes the device, its intended use, and comparative testing against a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily evaluated against two standards: ASTM D6319-10(2015) for Nitrile Examination Gloves (General Characteristics) and ASTM D6978-05(2013) for Chemotherapy Drug Permeation. Specific acceptance criteria are not explicitly stated for all parameters, but rather the performance of the proposed device is compared to the predicate device and relevant ASTM standards.
The table below summarizes the key performance characteristics and reported results. For characteristics not explicitly having acceptance criteria listed as a specific number, the "Comparison" column indicates if the device is "Same" or "Similar" to the predicate, implying it meets comparable performance.
| Test Parameter / Acceptance Criteria (as per ASTM standards or comparison) | Reported Device Performance (Proposed Device K182600) |
|---|---|
| General Characteristics (ASTM D6319-10(2015)) | |
| Length | Minimum 230mm |
| Palm Width (XS) | $70\pm10$ mm |
| Palm Width (S) | $80\pm10$ mm |
| Palm Width (M) | $95\pm10$ mm |
| Palm Width (L) | $110\pm10$ mm |
| Palm Width (XL) | $120\pm10$ mm |
| Thickness (Finger) | Minimum 0.05 mm |
| Thickness (Palm) | Minimum 0.05 mm |
| Tensile Strength, Before Aging | 14MPa, min |
| Ultimate Elongation, Before Aging | 500%, min |
| Tensile Strength, After Accelerated Aging | 14MPa, min |
| Ultimate Elongation, After Accelerated Aging | 400%, min |
| Freedom from holes (ASTM D 5151-06, AQL 2.5) | In accordance with ASTM D 5151-06, following ASTM D6319-10, G-1, AQL 2.5 |
| Powder-Content | $\le2$ mg per glove |
| Biocompatibility (ISO 10993) | |
| ISO 10993-10:2010 Skin Irritation Study | Not an irritant |
| ISO 10993-10:2010 Maximization Sensitization Study | Not a sensitizer |
| ISO 10993-5:2009 Cytotoxicity Test | Not a cytotoxic potential |
| Chemotherapy Drug Permeation (ASTM D6978-05(2013)) | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or test replicates) used for each individual test (e.g., tensile strength, freedom from holes, chemotherapy permeation). It references the ASTM standards, which typically define the appropriate sample sizes and testing methodologies.
The data provenance is from non-clinical testing conducted by Better Care Plastic Technology Co., Ltd. located in Hebei Province, China. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation of these medical gloves relies on objective measurements performed according to recognized international standards (ASTM, ISO). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes for this type of device. The "truth" is established by the standardized test methods themselves and the resulting physical and chemical measurements.
4. Adjudication method for the test set
This information is not applicable. The tests performed are objective, quantitative measurements according to predefined standards. There is no subjective assessment requiring adjudication.
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 is a medical glove, a physical device, and not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is based on objective measurements derived from standardized test methods (ASTM D6319-10, ASTM D6978-05, ISO 10993 series). For example:
- Physical properties (e.g., tensile strength, elongation): Measured directly by testing equipment following ASTM protocols.
- Freedom from holes: Determined by a standardized water-leak test (ASTM D5151-06).
- Chemotherapy drug permeation: Measured by detecting the breakthrough of chemotherapy drugs through the glove material over time, as per ASTM D6978-05.
- Biocompatibility: Evaluated using established in-vitro and in-vivo biological tests (cytotoxicity, irritation, sensitization) according to ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of validating a medical glove. The product is manufactured and then tested to ensure it meets performance standards.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.