(27 days)
Not Found
No
The device is a physical examination glove and the description focuses on material properties and performance testing, with no mention of AI or ML.
No
The device is an examination glove, which acts as a barrier to prevent contamination, not to treat or cure a disease or condition.
No
This device is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove made of nitrile latex, not software. The description focuses on material properties and performance testing of the physical glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- Device Description: The description focuses on the physical properties and materials of the glove, and its testing for resistance to certain substances.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Studies: The performance studies focus on the physical integrity, barrier properties, and biocompatibility of the glove, not on its ability to detect or measure substances in a biological sample.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This glove serves a protective function, not a diagnostic one.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM 06978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing was performed. Testing included:
- ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Purpose was to demonstrate barrier properties of gloves to permeation of Fentanyl Citrate solution. Result: No breakthrough detected during 240 minute test duration.
- Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151-19: Purpose was to demonstrate glove integrity. Criteria: Freedom from holes AQL 1.5%. Result: Pass.
- Standard Test Method for Residual Powder on Medical Gloves ASTM D6124-06(R17): Purpose was to demonstrate the gloves are 'powder free'. Criteria: Average less than 2 mg/glove. Result: Pass.
- Dimensional Conformance ASTM D6319: Purpose was to demonstrate appropriate dimensions for labeled sizes. Criteria: Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL AQL 4%. Result: Pass.
- Tensile Performance ASTM D6319: Purpose was to demonstrate adequate tensile properties. Criteria: Conforms to ASTM D6319 tensile strength of at least 14MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14MPa and ultimate strength of at least 400% after accelerated aging AQL 4%. Result: Pass.
- Biocompatibility: Skin Irritation ISO 10993-10: Purpose was to demonstrate low potential for skin irritation. Criteria: Under the conditions of the study, not an irritant. Result: Pass.
- Biocompatibility: Skin Sensitization ISO 10993-10: Purpose was to demonstrate low potential for skin sensitization. Criteria: Under the conditions of the study, not a sensitizer. Result: Pass.
- Biocompatibility: Acute Toxicity ISO 10993-11: Purpose was to demonstrate low acute toxicity. Criteria: Under the conditions of the study, no acute toxicity. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 8, 2025
Hartalega NGC Sdn. Bhd. Nurul Aisyah Kong General Manager - Quality Assurance No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung Sepang, Selangor 43900 Malaysia
Re: K243818
Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) 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: November 29, 2024 Received: December 12, 2024
Dear Nurul Aisyah Kong:
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 (the 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.
1
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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows the text "Allan Guan -S" in a large, sans-serif font. The text is black and is set against a white background. There is a faint, light blue watermark in the background, but it does not obscure the text. The text is horizontally oriented and centered.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices 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) K243818
Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Indications for Use (Describe)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM 06978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine, 3.3 mg/ml | 10.2 |
| Cisplatin, 1.0 mg/ml | >240 |
| Cyclophosphamide, 20.0 mg/ml | >240 |
| Dacarbazine, 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride, 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, 10.0 mg/ml | 30.2 |
| Vincristine Sulfate, 1.0 mg/ml | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | >240 |
| Bortezomib, 1.0 mg/ml | >240 |
| Busulfan, 6.0 mg/ml | >240 |
| Carboplatin, 10.0 mg/ml | >240 |
| Chloroquine, 50.0 mg/ml | >240 |
| Cyclosporin A, 100.0 mg/ml | >240 |
| Cytarabine, 100.0 mg/ml | >240 |
| Daunorubicin, 5.0 mg/ml | >240 |
| Docetaxel, 10.0 mg/ml | >240 |
| Epirubicin, 2.0 mg/ml | >240 |
| Fludarabine, 25.0 mg/ml | >240 |
| Gemcitabine, 38.0 mg/ml | >240 |
| Idarubicin, 1.0 mg/ml | >240 |
| Ifosfamide, 50.0 mg/ml | >240 |
| Irinotecan, 20.0 mg/ml | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | >240 |
| Melphalan, 5.0 mg/ml | >240 |
| Mitoxantrone, 2.0 mg/ml | >240 |
| Oxaliplatin, 2.0 mg/ml | >240 |
| Paraplatin, 1.0 mg/ml | >240 |
| Retrovir, 10.0 mg/ml | >240 |
| Rituximab, 10.0 mg/ml | >240 |
| Topotecan, 1.0 mg/ml | >240 |
4
| Trisenox, 1.0 mg/ml | > 240 |
|---|---|
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 |
Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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5
K243818
SPECIAL 510(k) SUMMARY
FOR
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE (BLUE)
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
SUBMISSION APPLICANT
| Date Prepared | : January 6, 2025 |
|---|---|
| Name | : Hartalega NGC Sdn. Bhd. |
| Address | : No. 1, Persiaran Tanjung, |
| Kawasan Perindustrian Tanjung | |
| 43900 Sepang, Selangor, | |
| Malaysia | |
| Establishment Registration Number | : 3011200663 |
SUBMISSION CORRESPONDENT AND/OR PREPARER
| Contact Name | : | Nurul Aisyah Kong |
|---|---|---|
| Contact Title | : | General Manager – Quality Assurance |
| Phone Number | : | (603) 3280 3888 |
| Fax Number | : | (603) 3271 0135 |
| Contact Email | : | wkkong@hartalega.com.my |
DEVICE IDENTIFICATION
| Common Name of the Device | : | Examination Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use with |
| Chemotherapy Drugs and Fentanyl Citrate (Blue) | ||
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, QDO, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |
PREDICATE DEVICE INFORMATION
| 510(k) Number | : | K222225 |
|---|---|---|
| Manufacturer | : | Hartalega NGC Sdn. Bhd. |
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use with |
| Chemotherapy Drugs (Blue) | ||
| Device Class | : | 1 |
| Product Code | : | LZA, LZC |
6
DESCRIPTION OF THE DEVICE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. 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).
DEVICE MODIFICATION:
The proposed modification to the predicate device is the inclusion of the subject device has been tested for use with fentanyl citrate in addition to its existing claim of use with chemotherapy drugs. The proposed device (physically identical to the predicate device) was tested for use with fentanyl citrate as per ASTM D6978. There are no differences with these two gloves in materials, manufacturing process and compliance with ASTM D6319 performance specifications.
INDICATIONS FOR USE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (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 (10.0 mg/ml) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Bleomycin Sulfate, 15.0 mg/ml | > 240 |
| Bortezomib, 1.0 mg/ml | > 240 |
| Busulfan, 6.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 |
| Chloroquine, 50.0 mg/ml | > 240 |
7
| Cyclosporin A, 100.0 mg/ml | > 240 |
|---|---|
| Cytarabine, 100.0 mg/ml | > 240 |
| Daunorubicin, 5.0 mg/ml | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 |
| Fludarabine, 25.0 mg/ml | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 |
| Idarubicin, 1.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 |
| Mechlorethamine HCI, 1.0 mg/ml | > 240 |
| Melphalan, 5.0 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 |
| Paraplatin, 10.0 mg/ml | > 240 |
| Retrovir, 10.0 mg/ml | > 240 |
| Rituximab, 10.0 mg/ml | > 240 |
| Topotecan, 1.0 mg/ml | > 240 |
| Trisenox, 1.0 mg/ml | > 240 |
Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100 mcg/2ml | > 240 |
8
| Characteristics
and Parameters | Subject Device | Predicate Device
(K222225) | Discussion |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Nitrile Powder Free Examination Glove
Tested for Use with Chemotherapy Drugs
and Fentanyl Citrate (Blue) | Nitrile Powder Free Examination Glove
Tested for Use with Chemotherapy Drugs
(Blue) | Similar |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC | Similar |
| Classification | 1 | 1 | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Regulation
Name | Patient Examination Glove | Patient Examination Glove | Same |
| Indications for
Use | A non-sterile disposable device intended for
medical purpose that is worn on the
examiner's hand to prevent contamination
between patient and examiner. It is also tested
to be used against Chemotherapy Drugs and
Fentanyl Citrate. | A non-sterile disposable device intended for
medical purpose that is worn on the
examiner's hand to prevent contamination
between patient and examiner. It is also tested
to be used against Chemotherapy Drugs. | Similar |
| | The gloves were tested for use with
chemotherapy drugs and Fentanyl Citrate as
per ASTM D6978-05 (Reapproved 2019)
Standard Practice for Assessment
of | The gloves were tested for use with
chemotherapy drugs as per ASTM D6978-05
(Reapproved 2019) Standard Practice for
Assessment of Resistance of Medical Gloves | |
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Chemotherapy Drug
and Concentration | Minimum
Breakthrough
Detection Time in
Minutes | Chemotherapy Drug
and Concentration | Minimum
Breakthrough
Detection Time in
Minutes |
|-------------------------------------------|---------------------------------------------------------|-------------------------------------------|---------------------------------------------------------|
| Carmustine, 3.3 mg/ml | 10.2 | Carmustine, 3.3 mg/ml | 10.2 |
| Cisplatin, 1.0 mg/ml | > 240 | Cisplatin, 1.0 mg/ml | > 240 |
| Cyclophosphamide
(Cytoxan), 20.0 mg/ml | > 240 | Cyclophosphamide
(Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine, 10.0 mg/ml | > 240 | Dacarbazine, 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride,
2.0 mg/ml | > 240 | Doxorubicin Hydrochloride,
2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0
mg/ml | > 240 | Etoposide (Toposar), 20.0
mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 | Fluorouracil, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 | Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 | Mitomycin C, 0.5 mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 | Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| Thiotepa, 10.0 mg/ml | 30.2 | Thiotepa, 10.0 mg/ml | 30.2 |
| Vincristine Sulfate, 1.0
mg/ml | > 240 | Vincristine Sulfate, 1.0
mg/ml | > 240 |
| Bleomycin Sulfate, 15.0
mg/ml | > 240 | Bleomycin Sulfate, 15.0
mg/ml | > 240 |
| Bortezomib, 1.0 mg/ml | > 240 | Bortezomib, 1.0 mg/ml | > 240 |
| Busulfan, 6.0 mg/ml | > 240 | Busulfan, 6.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 | Carboplatin, 10.0 mg/ml | > 240 |
| Chloroquine, 50.0 mg/ml | > 240 | Chloroquine, 50.0 mg/ml | > 240 |
| Cyclosporin A, 100.0 mg/ml | > 240 | Cyclosporin A, 100.0 mg/ml | > 240 |
| Cytarabine, 100.0 mg/ml | > 240 | Cytarabine, 100.0 mg/ml | > 240 |
| Daunorubicin, 5.0 mg/ml | > 240 | Daunorubicin, 5.0 mg/ml | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 | Docetaxel, 10.0 mg/ml | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 | Epirubicin, 2.0 mg/ml | > 240 |
| Fludarabine, 25.0 mg/ml | > 240 | Fludarabine, 25.0 mg/ml | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 | Gemcitabine, 38.0 mg/ml | > 240 |
| Idarubicin, 1.0 mg/ml | > 240 | Idarubicin, 1.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 | Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 | Irinotecan, 20.0 mg/ml | > 240 |
| Mechlorethamine HCl, 1.0
mg/ml | > 240 | Mechlorethamine HCl, 1.0
mg/ml | > 240 |
| Melphalan, 5.0 mg/ml | > 240 | Melphalan, 5.0 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 | Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 | Oxaliplatin, 2.0 mg/ml | > 240 |
| Paraplatin, 10.0 mg/ml | > 240 | Paraplatin, 10.0 mg/ml | > 240 |
9
| Characteristics
and Parameters | Subject Device | Predicate Device
(K222225) | Discussion | | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------|
| | Rituximab, 10.0 mg/ml
Topotecan, 1.0 mg/ml
Trisenox, 1.0 mg/ml | > 240
240
240 | Rituximab, 10.0 mg/ml
Topotecan, 1.0 mg/ml
Trisenox, 1.0 mg/ml | > 240
240
240 | |
| | Caution: Testing showed a minimum
breakthrough time of 10.2 minutes with
Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and
Thiotepa | | Caution: Testing showed an average
breakthrough time of 10.2 minutes with
Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and
Thiotepa | | |
| | Fentanyl Citrate and
Concentration
Fentanyl Citrate, 100.0
mcg/2ml | Minimum
Breakthrough
Detection Time in
Minutes
240 | N/A | | Fentanyl Citrate
was tested on
subject device:
Different |
| Type of use | Over the counter use | | Over the counter use | | Same |
| Materials | Nitrile | | Nitrile | | Same |
| Color | Blue | | Blue | | Same |
| Design | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | | Same |
| Sterility | Non-sterile | | Non-sterile | | Same |
| Freedom from
holes | Meets ASTM D5151-19 and ASTM D6319-
19:
AQL 1.5 | | Meets ASTM D5151-19 and ASTM D6319-
19:
AQL 1.5 | | Same |
| Length | Meets ASTM D6319-19:
$\ge$ 230 mm | | Meets ASTM D6319-19:
$\ge$ 230 mm | | Same |
| Dimensions | Meets ASTM D6319-19:
XS - 70 ± 10 mm
S - 80 ± 10 mm
M - 95 ± 10 mm
L - 110 ± 10 mm
XL - 120 ± 10 mm | | Meets ASTM D6319-19:
XS - 70 ± 10 mm
S - 80 ± 10 mm
M - 95 ± 10 mm
L - 110 ± 10 mm
XL - 120 ± 10 mm | | Same |
| Thickness | Meets ASTM D6319-19:
Palm Thickness: Min 0.05 mm
Finger Thickness: Min 0.05 mm | | Meets ASTM D6319-19:
Palm Thickness: Min 0.05 mm
Finger Thickness: Min 0.05 mm | | Same |
| Physical
Properties | Meets ASTM D6319-19:
Tensile Strength Before Aging: $\ge$ 14 MPa
Tensile Strength After Aging: $\ge$ 14 MPa
Ultimate Elongation Before Aging: $\ge$ 500 %
Ultimate Elongation After Aging: $\ge$ 400 % | | Meets ASTM D6319-19:
Tensile Strength Before Aging: $\ge$ 14 MPa
Tensile Strength After Aging: $\ge$ 14 MPa
Ultimate Elongation Before Aging: $\ge$ 500 %
Ultimate Elongation After Aging: $\ge$ 400 % | | Same |
| Powder residual | Meets ASTM D6319-19 &
ASTM D6124-06 (2017):
Residual Powder: $\le$ 2 mg per glove | | Meets ASTM D6319-19 &
ASTM D6124-06 (2017):
Residual Powder: $\le$ 2 mg per glove | | Same |
| Primary Skin
Irritation
ISO 10993-10 | Under the conditions of the study, the device
is not an irritant | | Under the conditions of the study, the device
is not an irritant | | Same |
| Dermal
Sensitization
ISO 10993-10 | Under the conditions of the study, the device
is not a sensitizer | | Under the conditions of the study, the device
is not a sensitizer | | Same |
10
| Characteristics
and Parameters | Subject Device | Predicate Device
(K222225) | Discussion |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------|
| Acute Systemic
Toxicity Test
ISO 10993-11 | Under the conditions of this study, the
device showed no evidence of acute
systemic toxicity | Under the conditions of this study, the
device showed no evidence of acute
systemic toxicity | Same |
The subject device and the predicate device are identical. However, the subject device has been tested for use with both chemotherapy drugs and fentanyl citrate, whereas the predicate device has only been tested for use with chemotherapy drugs.
SUMMARY OF NON-CLINICAL TESTING:
The subject device and the predicate device share intended use, identical material and identical manufacturing, and therefore share the same chemotherapy drug permeation testing, biocompatibility characteristics and compliance with ASTM D6319. Fentanyl citrate permeation testing was performed on the subject glove using the ASTM D6978 method
| Testing Performed | Purpose | Criteria | Result |
|---|---|---|---|
| ASTM D6978 | |||
| Standard Practice for | |||
| Assessment of Resistance of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy Drugs | Demonstrate barrier properties of | ||
| gloves to permeation of Fentanyl | |||
| Citrate solution | N/A | No breakthrough detected during 240 | |
| minute test duration |
The following testing was previously performed on the physically-identical predicate device.
| Test | Purpose | Criteria | Result |
|---|---|---|---|
| Standard Test Method for | |||
| Detection of Holes in Medical | |||
| Gloves | |||
| ASTM D5151-19 | To demonstrate glove integrity | Freedom from holes | |
| AQL 1.5% | Pass | ||
| Standard Test Method for | |||
| Residual Powder on Medical | |||
| Gloves | |||
| ASTM D6124-06(R17) | To demonstrate the gloves are 'powder | ||
| free' | Average less than 2 mg/glove | Pass | |
| Dimensional Conformance | |||
| ASTM D6319 | To demonstrate appropriate dimensions | ||
| for labeled sizes | Conforms to ASTM D6319 | ||
| width, thickness, and length | |||
| requirements for XS, S, M, L, | |||
| and XL | |||
| AQL 4% | Pass | ||
| Tensile Performance | |||
| ASTM D6319 | To demonstrate adequate tensile | ||
| properties | Conforms to ASTM D6319 | ||
| tensile strength of at least | |||
| 14MPa and ultimate elongation | |||
| of at least 500% requirements | |||
| prior to aging, and tensile | |||
| strength of at least 14MPa and | |||
| ultimate strength of at least | |||
| 400% after accelerated aging | |||
| AQL 4% | Pass | ||
| Biocompatibility: Skin | |||
| Irritation | |||
| ISO 10993-10 | To demonstrate low potential for skin | ||
| irritation | Under the conditions of the | ||
| study, not an irritant. | Pass | ||
| Biocompatibility: Skin | |||
| Sensitization | |||
| ISO 10993-10 | To demonstrate low potential for skin | ||
| sensitization | Under the conditions of the | ||
| study, not a sensitizer | Pass | ||
| Biocompatibility: | |||
| Acute Toxicity | |||
| ISO 10993-11 | To demonstrate low acute toxicity | Under the conditions of the | |
| study, no acute toxicity. | Pass |
11
CLINICAL PERFORMANCE DATA:
Not applicable.
CONCLUSION:
The conclusions drawn from the non-clinical testing demonstrates that the subject device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) K222225.