(63 days)
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)
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.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 (Min 14 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 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 indicates that the requirements of the ISO Acute Systemic Injection Test have been met by the test article. |
| ASTM D6978-05 (Reapproved 2019) | Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | Minimum Breakthrough Detection Time for various chemotherapy drugs, Fentanyl Citrate, and other select drugs (specific values listed in the "Indications for Use" and "Chemotherapy Permeation, Fentanyl Citrate, and Select Other Drugs Comparison Claim" tables). | See detailed breakthrough times in original document, with most being >240 minutes, except for Carmustine and Thiotepa which have lower breakthrough times (e.g., Carmustine 11.7-15.3 min, Thiotepa 15.4-36.4 min). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.
- Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.
7. The Type of Ground Truth Used:
The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
- Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
- Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
- Freedom from holes is evaluated by ASTM D5151-19.
- Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).
8. The Sample Size for the Training Set:
This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as there is no training set for this type of device.
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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.
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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
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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
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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
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| 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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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 |
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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.
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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 andParameters | Subject Device | Predicate DeviceK221269 | ComparisonResult |
|---|---|---|---|
| Trade Name | Powder Free Nitrile ExaminationGloves (Violet, Black, Green), Testedfor Use with Chemotherapy Drugs,Fentanyl Citrate and Select OtherDrugs | Powder Free Nitrile ExaminationGloves (Blue),Tested for Use withChemotherapy Drugs and FentanylCitrate | 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 deviceintended for medical purposes that isworn on the examiner's hand to preventcontamination between patient andexaminer.Gloves have been tested for use withchemotherapy drugs, Fentanyl Citrateand Other Select Drugs using ASTMD6978-05(2019) | The glove is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner.Gloves have been tested for use withchemotherapy drugs and FentanylCitrate 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 andother select drugsClaim | 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 DeviceK221269 | ComparisonResult |
|---|---|---|---|
| Length (mm) (Minimum) | XS: ≥ 220 mmS: ≥ 220 mmM: ≥ 230 mmL: ≥ 230 mmXL: ≥ 230 mmXXL: ≥ 230 mm | XS: ≥ 220 mmS: ≥ 220 mmM: ≥ 230 mmL: ≥ 230 mmXL: ≥ 230 mmXXL: ≥ 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, AfterAccelerated Aging, min | 14MPa | 14MPa | Same |
| Ultimate Elongation, AfterAccelerated 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 CytotoxicityISO 10993-5 | The test article is consideredcytotoxic under the conditions ofthis test.Cytotoxicity concern wasaddressed by Acute SystemicInjection Test. | Under the conditions of thisstudy, the test article showedpotential toxicity to L929 cells.Cytotoxicity concern wasaddressed by Acute SystemicToxicity testing. | Same |
| Acute Systemic Injection TestISO 10993-11 | The test result indicate that therequirements of the ISO AcuteSystemic Injection Test have beenmet by the test article. | Under the conditions of thisstudy, there was no evidence ofsystemic toxicity from the testarticle. | Same |
| Dermal SensitizationISO 10993-10 | Under the conditions of thisprotocol, the test article did notelicit a sensitization response. | Under the conditions of thisstudy, the test article showed nosignificant evidence of causingskin sensitization | Same |
| Primary Skin IrritationISO 10993-23 | The test result showed that therequirements of the ISOIntracutaneous Reactivity Testhave been met by the test article. | The test result showed that theresponse of the test article wascategorized as negligible underthe test condition. | Same |
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Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
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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) | ComparisonResult | |||
|---|---|---|---|---|---|
| Violet | Black | Green | Predicate DeviceK221269 | ||
| 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 ofthe gloves | XS: ≥ 220 mmS: ≥ 220 mmM: ≥ 230 mmL: ≥ 230 mmXL: ≥ 230 mmXXL: ≥ 230 mm | Pass |
| ASTM D6319- 19 | To determine the PhysicalDimensions (Palm Width) | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL:120±10mmXXL:130±10mm | Pass |
| ASTM D6319- 19 | To determine the PhysicalDimensions (Thickness) | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16(2021) | To determine the PhysicalProperties | Tensile Strength (Min14MPa) and Elongation(Before Aging 500% andafter aging 400%) Min | Pass |
| ASTM D6319- 19ASTM D6124-06 (2022) | To determine the PowderResidue | Max 2mg/glove | Pass |
| ISO 10993 Part 10-2021 | Skin Sensitization Testing | Under the conditions ofthe study, the device isnot a sensitizer | Under the conditions ofthisprotocol, the test article didnot elicit a sensitizationresponse. |
| ISO 10993 Part 23-2021 | Skin irritation Testing | Under the conditions ofthe study, the device isnot an irritant | The test result showed thatthe requirements of the ISOIntracutaneous Reactivity |
{11}------------------------------------------------
Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300, China
510K Summary
| Test have been met by thetest article. | |||
|---|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicity reactivity | The test article isconsidered cytotoxic underthe conditions of this test.Cytotoxicity concern wasaddressed by AcuteSystemic Injection Test. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | No systemic toxicity | The test result indicate thatthe requirements of the ISOAcute Systemic InjectionTest have been met by thetest 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.
§ 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.