(183 days)
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per 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 powderfree, ambidextrous with beaded cuff, purple colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.
Here's a breakdown of the acceptance criteria and study information for the GenaCheck™ Nitrile Powder Free Examination Glove, based on the provided FDA document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Property | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Performance (ASTM D6319-19) | |||
| Length | Physical Dimensions Test | XS/S: ≥220 mm; M/L/XL: ≥230 mm | XS/S: ≥220 mm (Pass); M/L/XL: ≥230 mm (Pass) |
| Width | Physical Dimensions Test | XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm | XS: 73-78 mm (Pass); S: 84-88 mm (Pass); M: 93-98 mm (Pass); L: 103-108 mm (Pass); XL: 113-118 mm (Pass) |
| Thickness | Physical Dimensions Test | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Finger: 0.069-0.109 mm (Pass); Palm: 0.052-0.079 mm (Pass) |
| Watertightness (ASTM D5151-19) | |||
| Freedom from Holes | Watertightness Test | Met the requirements of ASTM D5151 AQL 2.5 | 0/125 (Pass) |
| Powder Content (ASTM D6124-06) | |||
| Powder Content | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.27-0.41 mg (Pass) |
| Physical Properties (ASTM D412-16) | |||
| Before Aging - Tensile Strength | Physical properties | ≥14 MPa | 14-27 MPa (Pass) |
| Before Aging - Ultimate Elongation | Physical properties | ≥500% | 516-769 % (Pass) |
| After Aging - Tensile Strength | Physical properties | ≥14 MPa | 14-20 MPa (Pass) |
| After Aging - Ultimate Elongation | Physical properties | ≥400% | 452-662 % (Pass) |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | Cytotoxicity | Under conditions of the study, device extract is cytotoxic. (This criteria seems to indicate the expected outcome of the test, rather than a desired performance threshold; however, the intent is likely to confirm that it is not cytotoxic, as shown in the predicate comparison for the predicate device, which states "device extract is cytotoxic" and is marked as "Same." This implies the predicate itself also had this result, and it's being compared for similarity, not necessarily for a "pass/fail" against a non-cytotoxic ideal in this context for substantial equivalence.) | Under conditions of the study, device extract is cytotoxic (Result confirms similarity to predicate's reported extract cytotoxicity). Note: Given the context of a 510(k) for an examination glove, this result, while listed as "cytotoxic", aligns with the predicate and might be interpreted as acceptable within the framework of demonstrating substantial equivalence, meaning the new device is no worse than the predicate in terms of cytotoxicity. It's unusual for "cytotoxic" to be an acceptance criteria, more commonly "non-cytotoxic". This phrasing might indicate a specific interpretation or comparison to the predicate's known characteristics. More commonly, "non-cytotoxic" is the desired outcome. |
| Acute Systemic Toxicity (ISO 10993-11) | Acute Systemic Toxicity | Under conditions of the study, device extract did not show acute systemic toxicity in vivo | Under conditions of the study, device extract did not show acute systemic toxicity in vivo (Pass) |
| Irritation (ISO 10993-23) | Irritation | Under conditions of the study, the device was non-irritating | Under conditions of the study, the device was non-irritating (Pass) |
| Sensitization (ISO 10993-10) | Sensitization | Under conditions of the study, the device is non-sensitizing | Under conditions of the study, the device is non-sensitizing (Pass) |
| Chemopermeation (ASTM D6978-05) | |||
| Carmustine (3.3 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication highlights "low permeation time" | 22.8 Minutes |
| Cisplatin (1.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication is for comparison to similar predicate results | > 240 Minutes |
| Cyclophosphamide (20.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Dacarbazine (10.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Doxorubicin HCI (2.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Etoposide (20.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Fluorouracil (50.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Methotrexate (25.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Mitomycin C (0.5 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Paclitaxel (6.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Thiotepa (10.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication highlights "low permeation time" | 37.9 Minutes |
| Vincristine Sulfate (1.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Fentanyl Citrate Inj. (100mcg/2ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
Study Details:
For medical gloves, the "study" demonstrating that the device meets acceptance criteria typically refers to a series of non-clinical, laboratory bench tests conducted according to recognized consensus standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. However, it references the standards used, which often specify sample sizes.
- For Watertightness Test (ASTM D5151-19), the result "0/125/Pass" indicates that 125 samples were tested, with 0 failures.
- For other tests like physical dimensions, powder content, and physical properties, the sample sizes are described by the respective ASTM standards but not explicitly listed in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical testing" (bench tests) rather than human subject studies, so there's no "retrospective or prospective" status in the same sense as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable for this type of device and study. The "ground truth" for non-clinical performance and material properties standards is established by the specifications defined within the referenced ASTM and ISO standards themselves (e.g., a tensile strength of ≥14 MPa, or a specific AQL for holes). There are no human experts classifying outcomes in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" are used for human-reviewed data sets (e.g., medical image interpretation consensus). For bench testing against pre-defined engineering and material specifications, the results are quantitative measurements compared directly to the acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of diagnostic tools (e.g., AI algorithms for interpreting medical images) with and without human readers' involvement. The device here is a medical glove, for which MRMC studies are not applicable.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study in the context of an "algorithm only" performance was not done. This concept is specific to software medical devices or AI algorithms. The GenaCheck™ glove is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on established industry and regulatory standards.
- For physical properties, it's defined quantities like minimum tensile strength (e.g., ≥14 MPa).
- For resistance to permeation by chemotherapy drugs, it's the measured "breakthrough detection time" according to the specified method (ASTM D6978-05).
- For biocompatibility, it's the absence of adverse biological reactions (non-irritating, non-sensitizing, no acute systemic toxicity, and comparison to predicate regarding cytotoxicity) as defined by ISO 10993 series.
8. The Sample Size for the Training Set
There is no training set for this device. Training sets are applicable to machine learning algorithms. The GenaCheck™ glove is a physical product, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
August 28, 2024
Genabio Diagnostics Inc. Vincent Cai Vice President of Research and Development 19 Crosby Dr. Ste. 220 Bedford, Massachusetts 01730
Re: K240545
Trade/Device Name: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: July 16, 2024 Received: July 17, 2024
Dear Vincent Cai:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices
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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240545
Device Name
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
Indications for Use (Describe)
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minute |
|---|---|---|
| Carmustine | 3.3 mg/ml | 22.8 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Methotrexate | 25.0 mg/ml | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| Thiotepa | 10.0 mg/ml | 37.9 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 Minutes |
| Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time | ||
|---|---|---|
| Fentanyl Citrate Injection | 100.0mcg/2ml | > 240 Minutes |
Please note that the following drugs have low permeation time: Carmustine 3.3 mg/ml 22.8 Minutes; Thiotepa 10.0 mg/ml 37.9 Minutes Warning: Do not use with Carmustine and Thiotepa.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
∑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Genabio Diagnostics Inc. Address: 19 Crosby Dr. Ste 220, Bedford, MA 01730, USA Contact: Vincent Cai, Vice President of Research & Development Email: Vincent.cai@genabio.com Date prepared: 08/06/2024
2.0 Device Information
Trade name: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL
3.0 Classification
Product code: LZA, LZC, QDO, OPJ Regulation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd Address: Lot 821, Jalan Matang, 34750 Matang, Perak, Malaysia Device Name: Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) Number: K192954
5.0 Device Description
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 powderfree, ambidextrous with beaded cuff, purple colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL.
The subject device is non-sterile.
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6.0 Indications for Use
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine | 3.3 mg/ml | 22.8 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Thiotepa | 10 mg/ml | 37.9 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
Tested chemotherapy drugs are as follows:
Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time
| Fentanyl Citrate Injection | 100.0 mcg/2ml | > 240 |
|---|
Please note that the following drugs have low permeation times:
Carmustine 3.3 mg/ml 22.8 Minutes; Thiotepa 10.0 mg/ml 37.9 Minutes; Warning: Do not use with Carmustine and Thiotepa.
7.0 Technological Characteristic Comparison Table
Table 1 – General Comparison
| Item | Subject Device | Predicate Device(K192954) | Remark |
|---|---|---|---|
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
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| Class | I | I | Same | |
|---|---|---|---|---|
| Sterility | Non-sterile | Non-sterile | Same | |
| Shelf-life | / | / | Same | |
| Materials | Nitrile | Nitrile | Same | |
| Available size | XS, S, M, L, XL | XS, S, M, L, XL | Same | |
| Rx or OTC | OTC | OTC | Same | |
| Indications for Use | The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Warning: Do not use with Carmustine and Thiotepa. | The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Warning: Do not use with Carmustine. | Same | |
| Powdered or Powder free | Powder free | Powder free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Same | |
| Dimensions(mm) | Length: | Length: XS/S/M/L/XL: | ||
| XS/S:≥220;M/L/XL: ≥230Width:XS: 70 ± 10;S: 80 ± 10;M: 95 ± 10;L: 110 ± 10;XL: 120 ± 10. | ≥240;Width:XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Similar | ||
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same | |
| Colorant | Purple | Blue | Different | |
| PhysicalProperties | Before Aging | TensileStrength $≥14MPa$ | TensileStrength $≥14MPa$ | Same |
| UltimateElongation $≥500%$ | UltimateElongation $≥500%$ | |||
| After Aging | TensileStrength $≥14MPa$ | TensileStrength $≥14MPa$ | Same | |
| UltimateElongation $≥400%$ | UltimateElongation $≥400%$ | |||
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL = 2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL = 1.5 | Same | |
| Powder Content | 0.27~0.41 mg per glove,Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124, ≤2mg/glove | Similar | |
| Biocompatibility | ISO 10993-10, -23;Under the conditions of the study, not an irritant or a sensitizer.ISO 10993-5Under conditions of the study, device extract is cytotoxic.ISO 10993-11;Under the conditions of the study, the test article did not show acute systemic toxicity in vivo. | ISO 10993-10;Under the conditions of the study, not an irritant or a sensitizer.ISO 10993-5Under conditions of the study, device extract is cytotoxic.ISO 10993-11;Under the conditions of the study, the test article showed no adverse biological reaction | Same | |
| Carmustine3.3 mg/ml | 22.8 Minutes | 18.2 Minutes | Similar | |
| Cisplatin1.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Chemotherapy Drugsand Fentanyl CitrateTested with MinimumBreakthroughDetection Time asTested per ASTMD6978 | Cyclophosphamide20.0 mg/ml | > 240 Minutes | > 240 Minutes | Same |
| Doxorubicin HCI2.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Dacarbazine 10.0mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Etoposide20.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Fluorouracil50.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Methotrexate25.0 mg/ml | > 240 Minutes | / | Different | |
| Mitomycin C0.5 mg/ml | > 240 Minutes | / | Different | |
| Paclitaxel6.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Thiotepa10.0 mg/ml | 37.9 minutes | 57.3 minutes | Similar | |
| Vincristine Sulfate1.0 mg/ml | > 240 Minutes | / | Different | |
| Fentanyl Citrateinjection 100mcg/2ml | > 240 Minutes | > 240 Minutes | Same |
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Analysis 1:
The physical dimensions of the subject device are similar to that the predicate device, and meet the requirements of ASTM D6319-19.
Analysis 2:
The powder content of the subject device is similar to that of the predicate device, and meets the requirements of ASTM D6124-06.
Analysis 3:
The breakthrough detection times of Carmustine and Thiotepa of subject device are similar with that of the predicate device. The Chemotherapy Labeling Claims has clearly defined on the labeling and therefore does not raise any new safety or performance questions.
8.0 Summary of Non-Clinical Testing Biocompatibility Testing
The biocompatibility evaluation for GENACHECK™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate was conducted in accordance with the following standards:
ISO 10993-10: 2021, Biological Evaluation of Medical Devices – Part 10: Tests for Skin Sensitization.
ISO 10993-23: 2021, Biological Evaluation of Medical Devices – Part 23: Tests for Irritation.
ISO 10993-5:2009, Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity.
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ISO 10993-11:2017, Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity.
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with Chemotherapy drugs and fentanyl citrate. In addition, the proposed device was tested according to ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs and fentanyl citrate.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
-
ASTM D6124-06 (2022), Standard Test Method for Residual Powder on Medical Gloves.
-
ASTM D5151-19(2023), Standard Test Method for Detection of Holes in Medical Gloves.
-
ASTM D6319-19(2023), Standard Specification for Nitrile Examination Gloves for Medical Application.
-
ASTM D6978-05 (2023), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
-
ASTM D412-16(2021), Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319-19(2023) | PhysicalDimensionsTest | Length:XS/S: ≥220; M/L/XL:≥230Width:XS: 70 ± 10;S: 80 ± 10;M: 95 ± 10;L: 110 ± 10;XL: 120 ± 10. | Length:XS/S: ≥220;M/L/XL:≥230Width:XS: 73-78/Pass;S: 84-88/Pass;M: 93-98/Pass;L: 103-108/Pass;XL: 113-118/Pass. |
| Finger: ≥0.05; Palm:≥0.05 | Thickness (mm):Finger:0.069-0.109/Pass;Palm:0.052-0.079/Pass | ||
| ASTM D5151-19 (2023) | Watertightness Testfor Detection ofHoles | Met the requirements of ASTMD5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124-06 (2022) | PowderContent | Meet the requirements of ASTMD6124 < 2.0mg | 0.27~0.41 mg |
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| ASTM D412-16 (2021) | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | 14-27 MPa/Pass |
|---|---|---|---|---|---|
| UltimateElongation | ≥500% | 516-769 %/Pass | |||
| AfterAging | TensileStrength | ≥14MPa | 14-20 MPa/Pass | ||
| UltimateElongation | ≥400% | 452-662 %/Pass | |||
| ISO 10993-5(2009) | Cytotoxicity | Non-In VitroCytotoxicity | Under conditions of the study, deviceextract is cytotoxic. | ||
| ISO 10993-11(2017) | Acute SystemicToxicity | Non-acute systemictoxicity | Under conditions of `the study,device extract did not show acutesystemic toxicity in vivo | ||
| ISO 10993-23(2021) | Irritation | Non-irritating | Under conditions of the study, thedevice was non-irritating. | ||
| ISO 10993-10(2021) | Sensitization | Non-sensitizing | Under conditions of the study, thedevice is non-sensitizing. |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device under K192954.
§ 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.