(109 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
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.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.
This document is a 510(k) Premarket Notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)". It describes the acceptance criteria and the study that proves the device meets those criteria, specifically for its resistance to chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05 (Reapproved 2019)) | For most chemotherapy drugs, a minimum breakthrough detection time (e.g., >240 minutes) is desired for adequate protection. Some drugs may have shorter accepted times based on their specific properties and risks. The predicate device (K151997) also established similar benchmark values. | The device reports the following minimum breakthrough detection times: |
- Carmustine (3.3 mg/ml): 10.2 minutes
- Thiotepa (10.0 mg/ml): 30.2 minutes
- All other 31 listed chemotherapy drugs (e.g., Cisplatin, Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Paclitaxel, etc.): >240 minutes
Note: A caution explicitly warns against use with Carmustine and Thiotepa due to the shorter breakthrough times. |
| Freedom from holes (ASTM D5151-19 and ASTM D6319-19) | AQL 1.5% | Pass |
| Residual Powder (ASTM D6124-06 (2017)) | Average less than 2 mg/glove | Pass |
| Dimensional Conformance (ASTM D6319-19) | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL (AQL 4%)- Length: ≥ 230 mm
- Width (XS: 70 ± 10 mm, S: 80 ± 10 mm, M: 95 ± 10 mm, L: 110 ± 10 mm, XL: 120 ± 10 mm)
- Palm Thickness: Min 0.05 mm
- Finger Thickness: Min 0.05 mm | Pass (Meets specified length, width, palm thickness, and finger thickness requirements. The document specifically states for length "≥ 230 mm" for the subject device and "≥ 240 mm" for the predicate, but both are considered "Same" with a combined ASTM D6319-19 approval) |
| Tensile Performance (ASTM D6319-19) | Conforms to ASTM D6319 tensile strength of at least 14 MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14 MPa and ultimate strength of at least 400% after accelerated aging (AQL 4%) | Pass |
| Biocompatibility: Skin Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant. | Pass (Under the conditions of the study, the device is not an irritant) |
| Biocompatibility: Skin Sensitization (ISO 10993-10) | Under the conditions of the study, not a sensitizer. | Pass (Under the conditions of the study, the device is not a sensitizer) |
| Biocompatibility: Acute Toxicity (ISO 10993-11) | Under the conditions of the study, no acute systemic toxicity. | Pass (Under the conditions of this study, the device showed no evidence of acute systemic toxicity) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test set within the provided tables (e.g., how many gloves were tested for holes, or how many individual glove samples were exposed to each chemotherapy drug). However, it indicates compliance with recognized standards (ASTM D5151-19, ASTM D6319-19, ASTM D6124-06, ASTM D6978-05). These standards typically specify the minimum sample sizes required for testing.
The data provenance is implied to be prospective testing conducted by the manufacturer (Hartalega NGC Sdn. Bhd.) to meet the requirements for their 510(k) submission. Given the company's address, the testing was likely conducted in Malaysia or an affiliated testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation of the device's performance against physicochemical and biological standards (like chemical permeation, physical properties, and biocompatibility) does not typically involve human experts establishing ground truth in the way a clinical diagnostic study would. The "ground truth" here is defined by the objective metrics and thresholds established by the ASTM and ISO standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments to resolve discrepancies. The tests described are objective, standardized laboratory 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
This is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance refers to the assessment of an AI system without human intervention, which does not apply here.
7. The Type of Ground Truth Used
The ground truth used for performance assessment of the Nitrile Powder Free Examination Glove is based on objective, standardized laboratory test results and their comparison against pre-defined acceptance criteria set by international standards:
- Chemotherapy Drug Permeation: Measured breakthrough times (in minutes) as per ASTM D6978-05 (Reapproved 2019). The standard itself establishes the methodology and criteria for evaluating resistance.
- Physical Properties: Measurements against specifications outlined in ASTM D5151-19 (freedom from holes), ASTM D6319-19 (dimensional conformance, tensile performance), and ASTM D6124-06 (R17) (residual powder).
- Biocompatibility: Results of tests performed according to ISO 10993-10 (skin irritation, skin sensitization) and ISO 10993-11 (acute systemic toxicity), which define the methods and expected outcomes for non-toxic materials.
8. The Sample Size for the Training Set
This is not applicable. The device is a manufactured product undergoing standardized testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as 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.