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510(k) Data Aggregation
(115 days)
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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards. Gloves is direct contact and not to be worn for more than 24 hours.
The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs And Fentanyl Citrate (Blue). The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-11 and permeability to chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019).
This document is a 510(k) premarket notification for "Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)". It details the device's characteristics, performance, and comparison to 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's performance is tested against various physical properties and chemical permeation criteria.
Physical Properties (based on ASTM D6319-19):
| Items | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Length | Minimum 230mm | All size ≥230 |
| Palm Width | XS: 70±10mm | 76-78mm |
| S: 80±10mm | 86-88 mm | |
| M: 95±10mm | 96-98mm | |
| L: 110±10mm | 106-108 mm | |
| XL: 120±10mm | 116-118 mm | |
| XXL: 130±10mm | 126-128 mm | |
| Thickness | Palm: 0.05mm (min) | 0.07-0.08mm |
| Finger: 0.05mm (min) | 0.09-0.11mm | |
| Tensile Strength, Before Aging | 14MPa, min | 15.7-20.6 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.5-19.5 MPa |
| Ultimate Elongation, Before Aging | 500%, min | 500-550% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 410-510% |
| Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 requirements |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg, meet requirements |
Chemotherapy Drug and Fentanyl Citrate Permeation (based on ASTM D6978 standards):
| Chemotherapy Drug / Fentanyl Citrate Concentration | Reported Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 22.4 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.3 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Note: For Carmustine and Thiotepa, the document explicitly states warnings due to low permeation times, even though they have a reported BDT.
Biocompatibility Studies (ISO 10993-10, ISO 10993-11, ISO 10993-5):
| Technological Characteristics | Standard / Test / FDA Guidance | Result Summary (Acceptance Criteria & Performance) |
|---|---|---|
| Primary Skin Irritation Test | ISO 10993-10:2010 | Meets (Under the conditions of the study, not an irritant) |
| Dermal Sensitization Assay | ISO 10993-10:2010 | Meets (Under the conditions of the study, not a sensitizer) |
| In Vitro Cytotoxicity Test | ISO 10993-5:2009 | The test article extract showed potential toxicity to L929 cells. Cytotoxicity concern was addressed by acute systematic toxicity testing. |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 | Meets (Under the conditions of this study, there was no evidence of systemic toxicity.) |
2. Sample size used for the test set and the data provenance
The document specifies the standards used for testing, which implicitly defines the sample sizes and testing methodologies. However, it does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for each chemotherapy drug).
- Standards Used: ASTM D6319-19 (for dimensions, physical properties, freedom from holes, powder content) and ASTM D6978-05(2019) (for permeability to chemotherapy drugs and Fentanyl Citrate). Biocompatibility testing was done per ISO 10993-10, ISO 10993-11, and ISO 10993-5.
- Data Provenance: Not explicitly stated, but based on the owner's identification (Grand Work Plastic Products Co., Ltd. in Hebei, China) and the contact information (Hongray USA Medical Products Inc. in Chino, California), the testing was likely conducted by or for the manufacturer, potentially in China or a contracted lab. The data is retrospective for the purpose of this 510(k) submission, as the tests have already been performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes the testing of physical and chemical properties of gloves against established industry standards. The "ground truth" here is the performance requirement defined by these standards, not expert consensus on medical images or clinical outcomes. The tests are objective measurements, not subjective expert interpretations.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, quantitative measurements against predefined specifications (e.g., minimum length, minimum tensile strength, breakthrough detection time). There is no "adjudication" in the sense of reconciling differing expert opinions.
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
Not applicable. This is a submission for sterile nitrile examination gloves, not an AI-powered diagnostic device. No human readers or AI assistance are involved in the performance evaluation of the gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is objective, laboratory-measured data based on established international standards:
- Physical properties (dimensions, strength, elongation, hole detection, powder content) are measured quantitatively according to ASTM D6319-19, ASTM D5151-19, and ASTM D6124-06(2017).
- Chemical permeation (breakthrough detection time for chemotherapy drugs and Fentanyl Citrate) is measured according to ASTM D6978-05(2019).
- Biocompatibility (skin irritation, sensitization, systemic toxicity, cytotoxicity) is assessed using in vitro and in vivo tests guided by ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
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