(204 days)
Not Found
No
The device is a disposable glove for preventing contamination, and the description focuses on material properties and performance against chemical permeation, with no mention of AI/ML.
No
The device is a glove for preventing contamination, not for treating a condition.
No
Explanation: The device is a glove intended to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical glove, a hardware component, and the summary describes its material properties and performance testing related to physical characteristics and chemical resistance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties and testing related to barrier protection and chemical resistance. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
The device is clearly described as a medical glove used for protection and barrier purposes.
N/A
Intended Use / Indications for Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8, Do not use |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 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, 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9, Do not use |
| 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 & other drugs | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
Please note that the following drugs have extremely low permeation times:
Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes
*Warning: Do not use with Carmustine and Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards: ASTM D6319-19 (Physical Dimensions, Physical Properties), ASTM D5151-19 (Water leak test), ASTM D6124-06 (Powder Residue), ASTM D6978-05 (Permeation by Chemotherapy Drugs), ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Irritation and Skin Sensitization), ISO 10993-11:2017 (Acute systemic toxicity study).
A clinical test, Modified DRAIZE-95 Test to Evaluate Low Dermatitis Potential of Medical Gloves, was completed with 305 subjects. The study evaluated whether the level of residual chemical additives in the subject device induced Type IV allergic contact sensitization by repetitive applications to the skin of normal healthy human volunteers using the modified Draize-95 test as recommended by the FDA. Under the conditions of this clinical trial, the subject device demonstrated reduced potential for sensitizing users to chemical additives.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Permeation by Chemotherapy Drugs: Minimum Breakthrough Detection Time (BDT) in Minutes (values vary by drug, with most being >240 minutes, but 22.8 minutes for Carmustine and 46.9 minutes for Thiotepa).
- Physical Dimensions: Length (Min 220mm for XS, S; Min 230mm for M-XXL), Palm Width (XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm), Thickness (Finger: 0.05mm (min), Palm: 0.05mm (min)).
- Physical Properties: Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% min, After Accelerated Aging 400% min).
- Water leak test: AQL 2.5 (ISO 2859-1).
- Powder Residue: Max 2mg/glove.
- Cytotoxicity: Test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing.
- Irritation and Skin Sensitization: No evidence of sensitization and irritation.
- Acute systemic toxicity study: No evidence of acute systemic toxicity.
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/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2025
Better Care Plastic Technology Co., Ltd. Chunyan Zhu General Manager Fugian Xi Road, West district of Shenze Industrial Base Shenze County, Hebei 050000 China
Re: K242533
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ Dated: August 20, 2024 Received: August 26, 2024
Dear Chunyan Zhu:
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/cdrb/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
Page 2
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 820.70) 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 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-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,
ALLAN GUAN-S
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) K242533
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatits Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8, Do not use |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 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, 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9, Do not use |
| 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 & other drugs | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
4
| Retrovir, 10mg/ml (10,000ppm) | >240 |
|---|---|
| ------------------------------- | ------ |
Please note that the following drugs have extremely low permeation times:
Carmustine: 22.8 minutes, Thiotepa: 46.9 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) |
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5
510(k) Summary (As required by 21 CFR 807.92)
510K Summary
The assigned 510(K) numbers: K242533
Date Prepared: March 17, 2025
1. Owner's Identification:
Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Contact: Ms. Chunyan Zhu / General Manager Tel:86-311-66179668 Email:ffdareg@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266)
4. Device Description:
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
The Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
The following Chemotherapy Drugs have been tested with these gloves:
6
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8, Do not use |
|---|---|
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 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, 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9, Do not use |
| 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 and other drugs | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes *Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of subject device and Predicate Device:
General Comparison Table:
| | Subject Device
K242533 | Predicate Device
K232266 | Comparison
Result |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Trade Name | Powder Free Nitrile Patient
Examination Gloves, Blue Colored, | Powder Free Nitrile Patient
Examination Gloves, Blue Colored, | Different* |
| | Non-Sterile, Low Dermatitis
Potential. Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate | Non-Sterile, Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate | |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The glove is a disposable device
intended for medical purposes that
is worn on the examiner's hand to
prevent contamination between
patient and examiner. Gloves have
been tested for use with
chemotherapy drugs and Fentanyl
Citrate using ASTM D6978-05. | The glove is a disposable device
intended for medical purposes that is
worn on the examiner's hand to
prevent contamination between
patient and examiner. Gloves have
been tested for use with
chemotherapy drugs and Fentanyl
Citrate using ASTM D6978-05 | Same |
| Material | Nitrile | Nitrile | Same |
| Powder or Powder
Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| 10993-5:2009
Cytotoxicity Test | The test article scored '4' at 24, 48,
and 72 ± 4 hours and is considered
cytotoxic under the conditions of
this test. Cytotoxicity concern was
addressed by acute systemic toxicity
testing. | Under the conditions of this study,
the test article extract showed
potential toxicity to L929 cells.
Cytotoxicity concern was addressed
by acute systemic toxicity testing. | Same |
| 10993-10:2010
Skin Irritation Study | Under the conditions of the study,
not an irritant | Under the conditions of the study,
not an irritant | Same |
| 10993-10:2010
Sensitization Study | Under the conditions of the study,
not a sensitizer | Under the conditions of the study,
not a sensitizer | Same |
| ISO 10993-11:2017
Acute Systemic
toxicity study | Under the conditions of this study,
there was no evidence of acute
systemic toxicity. | Under the conditions of this study,
there was no evidence of acute
systemic toxicity. | Same |
| Clinical test | Under the conditions of this clinical
trial, the subject device
demonstrated reduced potential for
sensitizing users to chemical
additives. | No Test | Different* |
| Chemotherapy Drugs
and Fentanyl Citrate
Claim | See below comparison table | See below comparison table | Same |
| Technological
Characteristics | Proposed Device
K242533 | Predicate Device
K232266 | Result of
comparison |
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Same |
| Palm Width (size) (mm) | | | |
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | Same |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before
Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,
Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After
Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, After
Accelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20
ASTM D5151
G-1, AQL 2.5 | 21 CFR 800.20
ASTM D5151
G-1, AQL 2.5 | Same |
| Powder-Content | 240 | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | Same |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 | 22.8 | Same |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | Same |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
9
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
|---|---|---|---|
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Melphalan, 5mg/ml (5,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 | 46.9 | Same |
| Topotecan, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Trisenox, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Velcade, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Fentanyl Citrate and other drugs | Minimum BDT (Minutes) | Result of | |
|---|---|---|---|
| Proposed Device | Predicate Device | comparison | |
| K242533 | K232266 | ||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 | >240 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | Same |
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions | ||
| Length | Min 220mm for size XS, S | ||
| Min 230mm for size M-XXL | Pass | ||
| ASTM D6319- 19 | Physical Dimensions | ||
| Palm Width | XS: 70±10mm | ||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | Pass |
10
| | | XL: 120±10mm
XXL: 130±10mm | |
|---------------------------------|--------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6319- 19 | Physical Dimensions
Thickness | Finger: 0.05mm (min)
Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19
ASTM D412-16 | Physical Properties | Tensile Strength (Min14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19
ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19
ASTM D6124-06 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation by
Chemotherapy Drugs | Refer above table | Pass |
| ISO 10993-5:2009 | Cytotoxicity | No cytotoxicity reactivity | The test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-10:2010 | Irritation and Skin
Sensitization | No skin sensitization and Skin irritation | Under the conditions of this study, there were no evidence of sensitization and irritation |
| ISO 10993-11:2017 | Acute systemic
toxicity
study | No adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic toxicity. |
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05, Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs. ●
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Irritation and Sensitization.
- . ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests For Acute systemic toxicity
8. Clinical Performance Data
11
| Test | Description | Results |
|---|---|---|
| Modified DRAIZE-95 | ||
| Test to Evaluate Low | ||
| Dermatitis Potential of | ||
| Medical Gloves | A 305 subject study was completed to evaluate | |
| whether the level of residual chemical | ||
| additives in the subject device induced Type | ||
| IV allergic contact sensitization by repetitive | ||
| applications to the skin of normal healthy | ||
| human volunteers using the modified Draize- | ||
| 95 test as recommended by the FDA. | Under the conditions of this | |
| clinical trial, the subject device | ||
| demonstrated reduced potential | ||
| for sensitizing users to chemical | ||
| additives. |
9. Conclusion:
The conclusions drawn from the nonclinical and clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.