(183 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the glove, with no mention of AI or ML. The testing described is standard for medical gloves.
No
The device is a medical glove intended to prevent contamination, not to treat or mitigate a disease or condition.
No
This device is a medical glove designed to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical medical glove, not a software-only device. The description focuses on material properties, physical performance, and biocompatibility testing of a tangible product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The description clearly states that the GenaCheck™ Nitrile Powder Free Examination Glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between the examiner and the patient. It is a barrier device used on the body (or in contact with the body during examination).
- Lack of Specimen Analysis: The device does not analyze any biological specimens. Its function is purely protective.
- Testing Focus: The testing described (biocompatibility, physical properties, permeation by chemotherapy drugs and fentanyl citrate) is focused on the glove's ability to act as a barrier and its safety for contact with skin, not on analyzing biological samples.
Therefore, based on the provided information, the GenaCheck™ Nitrile Powder Free Examination Glove is a medical device, specifically a medical glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LZA, LZC, ODO, OPJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- ISO 10993-11:2017, Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity.
Results:
- Cytotoxicity (ISO 10993-5): Under conditions of the study, device extract is cytotoxic.
- Acute Systemic Toxicity (ISO 10993-11): Under conditions of the study, device extract did not show acute systemic toxicity in vivo.
- Irritation (ISO 10993-23): Under conditions of the study, the device was non-irritating.
- Sensitization (ISO 10993-10): Under conditions of the study, the device is non-sensitizing.
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.
The performance testing was conducted 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
Results:
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 (2023) | Physical Dimensions Test | Length: XS/S: ≥220; M/L/XL: ≥230. Width: XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10. | Length: XS/S: ≥220; M/L/XL: ≥230. Width: 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 Test for Detection of Holes | Met the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124-06 (2022) | Powder Content | Meet the requirements of ASTM D6124 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 mg/ml): 37.9 minutes
- Vincristine Sulfate (1.0 mg/ml): > 240 Minutes
- Fentanyl Citrate injection (100.0 mcg/2ml): > 240 Minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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"
1
(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
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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.
4
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5
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.
6
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 Detection
Time 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 |
7
| 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: ≥230 | ||||
| Width: | ||||
| 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 | |
| Physical | ||||
| Properties | Before Aging | Tensile | ||
| Strength $≥14MPa$ | Tensile | |||
| Strength $≥14MPa$ | Same | |||
| Ultimate | ||||
| Elongation $≥500%$ | Ultimate | |||
| Elongation $≥500%$ | ||||
| After Aging | Tensile | |||
| Strength $≥14MPa$ | Tensile | |||
| Strength $≥14MPa$ | Same | |||
| Ultimate | ||||
| Elongation $≥400%$ | Ultimate | |||
| Elongation $≥400%$ | ||||
| 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 10993-5 | ||||
| Under 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 10993-5 | ||||
| Under 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 | |||
| Carmustine | ||||
| 3.3 mg/ml | 22.8 Minutes | 18.2 Minutes | Similar | |
| Cisplatin | ||||
| 1.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Chemotherapy Drugs | ||||
| and Fentanyl Citrate | ||||
| Tested with Minimum | ||||
| Breakthrough | ||||
| Detection Time as | ||||
| Tested per ASTM | ||||
| D6978 | Cyclophosphamide | |||
| 20.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Doxorubicin HCI | ||||
| 2.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Dacarbazine 10.0 | ||||
| mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Etoposide | ||||
| 20.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Fluorouracil | ||||
| 50.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Methotrexate | ||||
| 25.0 mg/ml | > 240 Minutes | / | Different | |
| Mitomycin C | ||||
| 0.5 mg/ml | > 240 Minutes | / | Different | |
| Paclitaxel | ||||
| 6.0 mg/ml | > 240 Minutes | > 240 Minutes | Same | |
| Thiotepa | ||||
| 10.0 mg/ml | 37.9 minutes | 57.3 minutes | Similar | |
| Vincristine Sulfate | ||||
| 1.0 mg/ml | > 240 Minutes | / | Different | |
| Fentanyl Citrate | ||||
| injection 100mcg/2ml | > 240 Minutes | > 240 Minutes | Same |
8
9
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.
10
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
| Test
| Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM | |||
| D6319-19 | |||
| (2023) | Physical | ||
| Dimensions | |||
| Test | Length: | ||
| XS/S: ≥220; M/L/XL: | |||
| ≥230 | |||
| Width: | |||
| XS: 70 ± 10; | |||
| S: 80 ± 10; | |||
| M: 95 ± 10; | |||
| L: 110 ± 10; | |||
| XL: 120 ± 10. | Length: | ||
| XS/S: ≥220; | |||
| M/L/XL: | |||
| ≥230 | |||
| Width: | |||
| 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 Test | ||
| for Detection of | |||
| Holes | Met the requirements of ASTM | ||
| D5151 AQL 2.5 | 0/125/Pass | ||
| ASTM D6124- | |||
| 06 (2022) | Powder | ||
| Content | Meet the requirements of ASTM | ||
| D6124 |