(63 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML technologies.
No.
The device description and intended use clearly state it is for preventing contamination between patient and examiner, which is a protective measure, not a therapeutic intervention.
No
The device description indicates it is a glove worn on the examiner's hand to prevent contamination and has been tested for use with chemotherapy drugs and Fentanyl Citrate. It does not perform any diagnostic function.
No
The device is a physical glove and the description focuses on its material properties and performance as a barrier, not on any software functionality.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device's Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
- Lack of Specimen Analysis: The description does not mention any analysis of human specimens. The testing performed (ASTM standards, chemotherapy drug permeation) relates to the physical properties and barrier function of the glove itself, not to the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of a medical device used for personal protection and infection control, not an In Vitro Diagnostic device.
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, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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: ASTM D6319- 19
Purpose: To determine the length of the gloves
Acceptance Criteria: XS: >= 220 mm S: >= 220 mm M: >= 230 mm L: >= 230 mm XL: >= 230 mm XXL: >= 230 mm
Results: Pass
Methodology: ASTM D6319- 19
Purpose: To determine the Physical Dimensions (Palm Width)
Acceptance Criteria: XS: 70+/-10mm S: 80+/-10mm M: 95+/-10mm L:110+/-10mm XL:120+/-10mm XXL:130+/-10mm
Results: Pass
Methodology: ASTM D6319- 19
Purpose: To determine the Physical Dimensions (Thickness)
Acceptance Criteria: Finger: 0.05mm (min) Palm: 0.05mm (min)
Results: Pass
Methodology: ASTM D6319- 19 ASTM D412-16(2021)
Purpose: To determine the Physical Properties
Acceptance Criteria: Tensile Strength (Min14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min
Results: Pass
Methodology: ASTM D6319- 19 ASTM D6124-06 (2022)
Purpose: To determine the Powder Residue
Acceptance Criteria: Max 2mg/glove
Results: Pass
Methodology: ISO 10993 Part 10-2021
Purpose: Skin Sensitization Testing
Acceptance Criteria: Under the conditions of the study, the device is not a sensitizer
Results: Under the conditions of this protocol, the test article did not elicit a sensitization response.
Methodology: ISO 10993 Part 23-2021
Purpose: Skin irritation Testing
Acceptance Criteria: Under the conditions of the study, the device is not an irritant
Results: The test result showed that the requirements of the ISO Intracutaneous Reactivity Test have been met by the test article.
Methodology: ISO 10993-5:2009
Purpose: Cytotoxicity testing
Acceptance Criteria: No Cytotoxicity reactivity
Results: The test article is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by Acute Systemic Injection Test.
Methodology: ISO 10993-11:2017
Purpose: Acute systemic toxicity study
Acceptance Criteria: No systemic toxicity
Results: The test result indicate that the requirements of the ISO Acute Systemic Injection Test have been met by the test article.
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 24, 2025
Lingshi Hongruida Health Protection Technology Co., Ltd. Chai Tinglong General Manager Yangjiayuan, Liangdu Town, Lingshi County Jinzhong, Shanxi 031300 China
Re: K243959
Trade/Device Name: Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs 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: February 14, 2025 Received: February 14, 2025
Dear Chai Tinglong:
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.
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,
Bifeng Qian -S
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)
Device Name
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
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, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time in Minutes | ||
|---|---|---|---|
| Violet | Black | Green | |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 15.3 | 12.6 | 11.7 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | >240 | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 | >240 | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | >240 | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 36.4 | 15.4 | 33.0 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Velcade (Bortezomib) 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
ugh Detection Time in Minutes Mınımum Breakthro Violet Black Green
4
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 | >240 |
|---|---|---|---|
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | >240 | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 36.4 minutes (Violet);
Carmustine: 12.6 minutes, Thiotepa: 15.4 minutes (Black);
Carmustine: 11.7 minutes, Thiotepa: 33.0 minutes (Green);
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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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5
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
The assigned 510(K) numbers: K243959 Date Prepared: February 14, 2025
1. Owner's Identification:
Lingshi Hongruida Health Protection Technology Co., Ltd. Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China Contact: Mr. Chai Tinglong / General Manager Tel: 0086-311-66179668 Email:ffdareg@hongray.com.cn
2. Device Identification:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs 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 Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentany) Citrate (K221269)
4. Device Description:
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and 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(2019) The following chemicals have been tested with these gloves:
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time in Minutes | ||
|---|---|---|---|
| Violet | Black | Green | |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Carmustine, 3.3 mg/ml (3,300 ppm) | 15.3 | 12.6 | 11.7 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 |
6
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 |
|---|---|---|---|
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 | >240 | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 | >240 | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 | >240 | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | >240 | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 36.4 | 15.4 | 33.0 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Fentanyl Citrate and Other Drugs | Minimum Breakthrough Detection Time in Minutes | ||
|---|---|---|---|
| Violet | Black | Green | |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Cyclosporin A, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 36.4 minutes (Violet);
Carmustine: 12.6 minutes, Thiotepa: 15.4 minutes (Black);
Carmustine: 11.7 minutes, Thiotepa: 33.0 minutes (Green);
Warning: Do not use with Carmustine and Thiotepa.
7
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
6. Comparison of Subject Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs & Fentanyl Citrate of the subject and predicate devices.
General Comparison Table:
| Characteristics and
Parameters | Subject Device | Predicate Device
K221269 | Comparison
Result |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Trade Name | Powder Free Nitrile Examination
Gloves (Violet, Black, Green), Tested
for Use with Chemotherapy Drugs,
Fentanyl Citrate and Select Other
Drugs | Powder Free Nitrile Examination
Gloves (Blue),Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC,QDO | Different* |
| 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, Fentanyl Citrate
and Other Select Drugs using ASTM
D6978-05(2019) | 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 | Similar |
| Material | Nitrile | Nitrile | Same |
| Color | Violet, Black, Green | Blue | Different** |
| Design | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | Same |
| Chemotherapy Drugs,
Fentanyl Citrate and
other select drugs
Claim | See below comparison table | See below comparison table | / |
- ODO and OPJ, both designated for Medical Gloves with Chemotherapy Labeling Claims - Test for Use with Chemotherapy Drugs, the subject device added the product code OPJ as per requirements but does not raise questions of safety and effectiveness.
** The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.
Technological Characteristic Comparison Table:
| Technological Characteristics | Subject Device | Predicate Device
K221269 | Comparison
Result |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | | | |
| Length (mm) (Minimum) | XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm
XXL: ≥ 230 mm | XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm
XXL: ≥ 230 mm | 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) (Minimum) | | | |
| Finger | 0.05 | 0.05 | Same |
| Palm | 0.05 | 0.05 | Same |
| Tensile Strength, Before Aging, min | 14MPa | 14MPa | Same |
| Ultimate Elongation,
Before Aging, min | 500% | 500% | Same |
| Tensile Strength, After
Accelerated Aging, min | 14MPa | 14MPa | Same |
| Ultimate Elongation, After
Accelerated Aging, min | 400% | 400% | Same |
| Freedom from holes | G-I, AQL 2.5 | G-I, AQL 2.5 | Same |
| Powder residual | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| In vitro Cytotoxicity
ISO 10993-5 | The test article is considered
cytotoxic under the conditions of
this test.
Cytotoxicity concern was
addressed by Acute Systemic
Injection Test. | Under the conditions of this
study, the test article showed
potential toxicity to L929 cells.
Cytotoxicity concern was
addressed by Acute Systemic
Toxicity testing. | Same |
| Acute Systemic Injection Test
ISO 10993-11 | The test result indicate that the
requirements of the ISO Acute
Systemic Injection Test have been
met by the test article. | Under the conditions of this
study, there was no evidence of
systemic toxicity from the test
article. | Same |
| Dermal Sensitization
ISO 10993-10 | Under the conditions of this
protocol, the test article did not
elicit a sensitization response. | Under the conditions of this
study, the test article showed no
significant evidence of causing
skin sensitization | Same |
| Primary Skin Irritation
ISO 10993-23 | The test result showed that the
requirements of the ISO
Intracutaneous Reactivity Test
have been met by the test article. | The test result showed that the
response of the test article was
categorized as negligible under
the test condition. | Same |
8
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
9
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
Chemotherapy Permeation, Fentanyl Citrate, and Select Other Drugs Comparison Claim:
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time
(Minutes) | | | | Comparison
Result |
|------------------------------------------------|--------------------------------------------------|-------|-------|-----------------------------|----------------------|
| | Violet | Black | Green | Predicate Device
K221269 | |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | >240 | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Carmustine, 3.3 mg/ml (3,300 ppm) | 15.3 | 12.6 | 11.7 | 11.1 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | >240 | Same |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | >240 | Same |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 | >240 | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 | >240 | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | >240 | >240 | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 36.4 | 15.4 | 33.0 | 21.6 | Similar |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
10
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
| Minimum Breakthrough Detection Time (Minutes) | |||||
|---|---|---|---|---|---|
| Fentanyl Citrate and Other Drugs | Subject Device | Predicate Device | Comparison Result | ||
| Violet | Black | Green | K221269 | ||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | >240 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | >240 | >240 | Same |
| Cyclosporin A, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this similar does not raise questions of safety and effectiveness of subject device.
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 | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | To determine the length of | ||
| the gloves | XS: ≥ 220 mm | ||
| S: ≥ 220 mm | |||
| M: ≥ 230 mm | |||
| L: ≥ 230 mm | |||
| XL: ≥ 230 mm | |||
| XXL: ≥ 230 mm | Pass | ||
| ASTM D6319- 19 | To determine the Physical | ||
| Dimensions (Palm Width) | XS: 70±10mm | ||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL:120±10mm | |||
| XXL:130±10mm | Pass | ||
| ASTM D6319- 19 | To determine the Physical | ||
| Dimensions (Thickness) | Finger: 0.05mm (min) | ||
| Palm: 0.05mm (min) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D412-16(2021) | To determine the Physical | ||
| Properties | Tensile Strength (Min14 | ||
| MPa) and Elongation | |||
| (Before Aging 500% and | |||
| after aging 400%) Min | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D6124-06 (2022) | To determine the Powder | ||
| Residue | Max 2mg/glove | Pass | |
| ISO 10993 Part 10-2021 | Skin Sensitization Testing | Under the conditions of | |
| the study, the device is | |||
| not a sensitizer | Under the conditions of | ||
| this | |||
| protocol, the test article did | |||
| not elicit a sensitization | |||
| response. | |||
| ISO 10993 Part 23-2021 | Skin irritation Testing | Under the conditions of | |
| the study, the device is | |||
| not an irritant | The test result showed that | ||
| the requirements of the ISO | |||
| Intracutaneous Reactivity |
11
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
| | | | Test have been met by the
test article. |
|-------------------|----------------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicity reactivity | The test article is
considered cytotoxic under
the conditions of this test.
Cytotoxicity concern was
addressed by Acute
Systemic Injection Test. |
| ISO 10993-11:2017 | Acute systemic toxicity
study | No systemic toxicity | The test result indicate that
the requirements of the ISO
Acute Systemic Injection
Test have been met by the
test article. |
- 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 (Reapproved 2022), Standard Test Method for Residual Powder on Medical Gloves
- . ASTM D412-16 ( 2021 ) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- 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 10: Tests for Skin 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
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.