(95 days)
The glove 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 and Fentanyl Citrate using ASTM D6978-05(2019)
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.
This document is a 510(k) summary for the Syntex Healthcare Products Co., Ltd.'s "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.
Here's the breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The device's performance is primarily evaluated against recognized standards for medical examination gloves and specific tests for chemical permeation.
| Acceptance Criteria (Standard & Parameter) | Reported Device Performance |
|---|---|
| Physical Dimensions (ASTM D6319-19) | |
| Length (XS, S) | Minimum 220mm (Pass) |
| Length (M-XXL) | Minimum 230mm (Pass) |
| Palm Width (XS) | 70±10mm (Pass) |
| Palm Width (S) | 80±10mm (Pass) |
| Palm Width (M) | 95±10mm (Pass) |
| Palm Width (L) | 110±10mm (Pass) |
| Palm Width (XL) | 120±10mm (Pass) |
| Palm Width (XXL) | 130±10mm (Pass) |
| Thickness (Finger) | Minimum 0.05mm (Pass) |
| Thickness (Palm) | Minimum 0.05mm (Pass) |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | |
| Tensile Strength (Before Aging) | 14MPa, min (Pass) |
| Ultimate Elongation (Before Aging) | 500%, min (Pass) |
| Tensile Strength (After Accelerated Aging) | 14MPa, min (Pass) |
| Ultimate Elongation (After Accelerated Aging) | 400%, min (Pass) |
| Water Leak Test (ASTM D6319-19, ASTM D5151-19) | |
| AQL | 2.5 (Pass) |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | |
| Max Powder/glove | ≤ 2 mg/glove (Pass) |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | |
| Azacytidine (25 mg/ml) | >240 minutes (Pass) |
| Bleomycin Sulfate (15mg/ml) | >240 minutes (Pass) |
| Busulfan (6mg/ml) | >240 minutes (Pass) |
| Carboplatin (10mg/ml) | >240 minutes (Pass) |
| Carmustine (3.3 mg/ml) | 12.9 minutes |
| Chloroquine (50mg/ml) | >240 minutes (Pass) |
| Cisplatin (1mg/ml) | >240 minutes (Pass) |
| Cyclophosphamide (20mg/ml) | >240 minutes (Pass) |
| Cyclosporin A (100 mg/ml) | >240 minutes (Pass) |
| Cytarabine HCL (100 mg/ml) | >240 minutes (Pass) |
| Dacarbazine (10 mg/ml) | >240 minutes (Pass) |
| Daunorubicin HCL (5 mg/ml) | >240 minutes (Pass) |
| Docetaxel (10 mg/ml) | >240 minutes (Pass) |
| Doxorubicin HCL (2 mg/ml) | >240 minutes (Pass) |
| Etoposide (20 mg/ml) | >240 minutes (Pass) |
| Epirubicin HCL (2 mg/ml) | >240 minutes (Pass) |
| Fludarabine (25 mg/ml) | >240 minutes (Pass) |
| Fluorouracil (50mg/ml) | >240 minutes (Pass) |
| Gemcitabine (38mg/ml) | >240 minutes (Pass) |
| Idarubicin HCL (1mg/ml) | >240 minutes (Pass) |
| Ifosfamide (50mg/ml) | >240 minutes (Pass) |
| Irinotecan (20mg/ml) | >240 minutes (Pass) |
| Mechlorethamine HCI (1mg/ml) | >240 minutes (Pass) |
| Melphalan (5mg/ml) | >240 minutes (Pass) |
| Methotrexate (25mg/ml) | >240 minutes (Pass) |
| Mitomycin C (0.5mg/ml) | >240 minutes (Pass) |
| Mitoxantrone HCL (2mg/ml) | >240 minutes (Pass) |
| Oxaliplatin (5mg/ml) | >240 minutes (Pass) |
| Paclitaxel (6mg/ml) | >240 minutes (Pass) |
| Paraplatin (10mg/ml) | >240 minutes (Pass) |
| Retrovir (10mg/ml) | >240 minutes (Pass) |
| Rituximab (10mg/ml) | >240 minutes (Pass) |
| Thio Tepa (10mg/ml) | 35.6 minutes |
| Topotecan (1mg/ml) | >240 minutes (Pass) |
| Trisenox (1mg/ml) | >240 minutes (Pass) |
| Velcade (Bortezomib) (1mg/ml) | >240 minutes (Pass) |
| Vincristine Sulfate (1mg/ml) | >240 minutes (Pass) |
| Vinorelbine (10 mg/ml) | >240 minutes (Pass) |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes (Pass) |
| Biocompatibility | |
| Irritation & Skin Sensitization (ISO 10993-10 & -23) | Non-sensitization and Non-irritation (Pass) |
| Cytotoxicity (ISO 10993-5) | Showed potential toxicity to L929 cells |
| Acute Systemic Toxicity (ISO 10993-11) | No evidence of acute systemic toxicity (Pass) |
| Bioburden Study (ISO 11737-1) | No increase in bioburden levels (Pass) |
Note on Chemotherapy Permeation: For Carmustine and Thio Tepa, the reported breakthrough detection times (12.9 minutes and 35.6 minutes respectively) are explicitly noted as "extremely low permeation times" and a warning is issued: "Do not use with Carmustine and Thio Tepa." This indicates that for these specific drugs, the device does not meet an implicit "long duration" acceptance criterion and thus, limitations are clearly stated for safe use.
The study that proves the device meets (or defines limitations for) these criteria is a Summary of Non-Clinical Performance Data (Section 7 and 10 of the provided document).
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of gloves for physical dimensions, individual tests for chemotherapy permeation, or biological evaluations). However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes for testing to ensure statistical validity.
The data provenance is from Syntex Healthcare Products Co., Ltd., located at No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China. These are retrospective tests conducted by the manufacturer as part of the premarket notification (510(k)) submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For non-clinical performance data like material testing and chemical permeation, "experts" in the sense of clinical decision-makers (e.g., radiologists) are not typically involved in establishing ground truth. The ground truth is objective, defined by the parameters of the test methods (e.g., measuring glove dimensions, detecting chemical breakthrough, evaluating cellular response). The tests are performed by personnel trained in the specific methodologies, likely in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
An adjudication method (like 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, often when establishing a ground truth from multiple reviewers. Since these are non-clinical laboratory tests with objectively measurable outcomes (e.g., min/mm measurements, detection of chemical permeation, biological response), an adjudication method is not applicable and therefore, none was used. The "ground truth" is determined by the direct results of the standardized 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:
No MRMC comparative effectiveness study was done. This type of study is completely irrelevant for a medical device such as examination gloves, which do not involve human readers or AI assistance in their function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm-only performance assessment was done. This device is an examination glove, not an AI or software-based medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical tests is based on objective measurements and observations according to established ASTM and ISO standards and methodologies.
- Physical properties and dimensions: Direct physical measurements.
- Chemical permeation: Detection of the breakthrough of specific chemicals through the glove material using analytical methods defined in ASTM D6978-05 (2019).
- Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) tests with defined endpoints and criteria.
- Bioburden: Microbiological testing to quantify microorganism levels.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning device, so there is no "training set." The data presented is from non-clinical performance testing of the final product.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply here.
§ 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.