(95 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 and Fentanyl Citrate using ASTM D6978-05(2019)
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) 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 D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.
This document is a 510(k) summary for the Syntex Healthcare Products Co., Ltd.'s "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.
Here's the breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The device's performance is primarily evaluated against recognized standards for medical examination gloves and specific tests for chemical permeation.
| Acceptance Criteria (Standard & Parameter) | Reported Device Performance |
|---|---|
| Physical Dimensions (ASTM D6319-19) | |
| Length (XS, S) | Minimum 220mm (Pass) |
| Length (M-XXL) | Minimum 230mm (Pass) |
| Palm Width (XS) | 70±10mm (Pass) |
| Palm Width (S) | 80±10mm (Pass) |
| Palm Width (M) | 95±10mm (Pass) |
| Palm Width (L) | 110±10mm (Pass) |
| Palm Width (XL) | 120±10mm (Pass) |
| Palm Width (XXL) | 130±10mm (Pass) |
| Thickness (Finger) | Minimum 0.05mm (Pass) |
| Thickness (Palm) | Minimum 0.05mm (Pass) |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | |
| Tensile Strength (Before Aging) | 14MPa, min (Pass) |
| Ultimate Elongation (Before Aging) | 500%, min (Pass) |
| Tensile Strength (After Accelerated Aging) | 14MPa, min (Pass) |
| Ultimate Elongation (After Accelerated Aging) | 400%, min (Pass) |
| Water Leak Test (ASTM D6319-19, ASTM D5151-19) | |
| AQL | 2.5 (Pass) |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | |
| Max Powder/glove | ≤ 2 mg/glove (Pass) |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | |
| Azacytidine (25 mg/ml) | >240 minutes (Pass) |
| Bleomycin Sulfate (15mg/ml) | >240 minutes (Pass) |
| Busulfan (6mg/ml) | >240 minutes (Pass) |
| Carboplatin (10mg/ml) | >240 minutes (Pass) |
| Carmustine (3.3 mg/ml) | 12.9 minutes |
| Chloroquine (50mg/ml) | >240 minutes (Pass) |
| Cisplatin (1mg/ml) | >240 minutes (Pass) |
| Cyclophosphamide (20mg/ml) | >240 minutes (Pass) |
| Cyclosporin A (100 mg/ml) | >240 minutes (Pass) |
| Cytarabine HCL (100 mg/ml) | >240 minutes (Pass) |
| Dacarbazine (10 mg/ml) | >240 minutes (Pass) |
| Daunorubicin HCL (5 mg/ml) | >240 minutes (Pass) |
| Docetaxel (10 mg/ml) | >240 minutes (Pass) |
| Doxorubicin HCL (2 mg/ml) | >240 minutes (Pass) |
| Etoposide (20 mg/ml) | >240 minutes (Pass) |
| Epirubicin HCL (2 mg/ml) | >240 minutes (Pass) |
| Fludarabine (25 mg/ml) | >240 minutes (Pass) |
| Fluorouracil (50mg/ml) | >240 minutes (Pass) |
| Gemcitabine (38mg/ml) | >240 minutes (Pass) |
| Idarubicin HCL (1mg/ml) | >240 minutes (Pass) |
| Ifosfamide (50mg/ml) | >240 minutes (Pass) |
| Irinotecan (20mg/ml) | >240 minutes (Pass) |
| Mechlorethamine HCI (1mg/ml) | >240 minutes (Pass) |
| Melphalan (5mg/ml) | >240 minutes (Pass) |
| Methotrexate (25mg/ml) | >240 minutes (Pass) |
| Mitomycin C (0.5mg/ml) | >240 minutes (Pass) |
| Mitoxantrone HCL (2mg/ml) | >240 minutes (Pass) |
| Oxaliplatin (5mg/ml) | >240 minutes (Pass) |
| Paclitaxel (6mg/ml) | >240 minutes (Pass) |
| Paraplatin (10mg/ml) | >240 minutes (Pass) |
| Retrovir (10mg/ml) | >240 minutes (Pass) |
| Rituximab (10mg/ml) | >240 minutes (Pass) |
| Thio Tepa (10mg/ml) | 35.6 minutes |
| Topotecan (1mg/ml) | >240 minutes (Pass) |
| Trisenox (1mg/ml) | >240 minutes (Pass) |
| Velcade (Bortezomib) (1mg/ml) | >240 minutes (Pass) |
| Vincristine Sulfate (1mg/ml) | >240 minutes (Pass) |
| Vinorelbine (10 mg/ml) | >240 minutes (Pass) |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes (Pass) |
| Biocompatibility | |
| Irritation & Skin Sensitization (ISO 10993-10 & -23) | Non-sensitization and Non-irritation (Pass) |
| Cytotoxicity (ISO 10993-5) | Showed potential toxicity to L929 cells |
| Acute Systemic Toxicity (ISO 10993-11) | No evidence of acute systemic toxicity (Pass) |
| Bioburden Study (ISO 11737-1) | No increase in bioburden levels (Pass) |
Note on Chemotherapy Permeation: For Carmustine and Thio Tepa, the reported breakthrough detection times (12.9 minutes and 35.6 minutes respectively) are explicitly noted as "extremely low permeation times" and a warning is issued: "Do not use with Carmustine and Thio Tepa." This indicates that for these specific drugs, the device does not meet an implicit "long duration" acceptance criterion and thus, limitations are clearly stated for safe use.
The study that proves the device meets (or defines limitations for) these criteria is a Summary of Non-Clinical Performance Data (Section 7 and 10 of the provided document).
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of gloves for physical dimensions, individual tests for chemotherapy permeation, or biological evaluations). However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes for testing to ensure statistical validity.
The data provenance is from Syntex Healthcare Products Co., Ltd., located at No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China. These are retrospective tests conducted by the manufacturer as part of the premarket notification (510(k)) submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For non-clinical performance data like material testing and chemical permeation, "experts" in the sense of clinical decision-makers (e.g., radiologists) are not typically involved in establishing ground truth. The ground truth is objective, defined by the parameters of the test methods (e.g., measuring glove dimensions, detecting chemical breakthrough, evaluating cellular response). The tests are performed by personnel trained in the specific methodologies, likely in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
An adjudication method (like 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, often when establishing a ground truth from multiple reviewers. Since these are non-clinical laboratory tests with objectively measurable outcomes (e.g., min/mm measurements, detection of chemical permeation, biological response), an adjudication method is not applicable and therefore, none was used. The "ground truth" is determined by the direct results of the standardized tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This type of study is completely irrelevant for a medical device such as examination gloves, which do not involve human readers or AI assistance in their function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm-only performance assessment was done. This device is an examination glove, not an AI or software-based medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical tests is based on objective measurements and observations according to established ASTM and ISO standards and methodologies.
- Physical properties and dimensions: Direct physical measurements.
- Chemical permeation: Detection of the breakthrough of specific chemicals through the glove material using analytical methods defined in ASTM D6978-05 (2019).
- Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) tests with defined endpoints and criteria.
- Bioburden: Microbiological testing to quantify microorganism levels.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning device, so there is no "training set." The data presented is from non-clinical performance testing of the final product.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply here.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 8, 2023
Syntex Healthcare Products Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K231643
Trade/Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: June 5, 2023 Received: August 7, 2023
Dear Kathy Liu:
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 (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 located 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}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Allan Guan -S
For Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231643
Device Name
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
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(2019)
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 |
| 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) | 12.9 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 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 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 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 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) | >240 |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 |
{3}------------------------------------------------
| Fentanyl Citrate | Minimum BDT Minutes |
|---|---|
| Fentanyl Citrate Injection | (100 mcg/2ml) >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Type of Use (Select one or both, as applicable)
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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{4}------------------------------------------------
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
Date Prepared: September 07, 2023
1. Owner's Identification:
Mr. Qiao Zhiqiang Syntex Healthcare Products Co., Ltd No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China Tel:86-311-66179668 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:909-590-1611 Email: fdareg(@)hongray.com.cn or janicema(@hongrayusa.com
2. Name of the Device:
Trade / Product Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, OPJ, QDO Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Primary Predicate Device: Hartalega NGC SDN. BHD. Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581)
Reference Device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269)
4. Device Description:
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) 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 D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.
5. Indications for Use:
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent
{5}------------------------------------------------
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 |
| 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) | 12.9 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 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 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 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 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) | >240 |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 |
{6}------------------------------------------------
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
| Fentanyl Citrate | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes
Warning: Do not use with Carmustine and Thio Tepa.
6. Comparison of Subject Device and Predicate Devices:
The following tables are summaries of the technological characteristics, biocompatibility and testing for the subject Device and predicate devices.
General Comparison Table:
| Subject DeviceK231643 | Predicate DeviceK200581 | Reference DeviceK221269 | Comparison | |
|---|---|---|---|---|
| Trade Name | Biodegradable NitrilePowder Free ExaminationGloves Tested for Use withChemotherapy Drugs andFentanyl Citrate(Blue) | Biodegradable NitrilePowder Free ExaminationGloves Tested for Use withChemotherapy Drugs andFentanyl Citrate (Blue) | Powder Free NitrileExamination Glove(Blue) Tested for Usewith ChemotherapyDrugs and FentanylCitrate | Similar |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC,QDO | LZA, LZC,QDO | Different* |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications forUse | Biodegradable NitrilePowder Free ExaminationGloves Tested for Use withChemotherapy Drugs andFentanyl Citrate (Blue) is adisposable device intendedfor medical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.Gloves have been tested foruse with chemotherapy drugsand Fentanyl Citrate usingASTM D6978-05(2019) | Biodegradable NitrilePowder Free Examination GlovesTested for Use withChemotherapy Drugs andFentanyl Citrate (Blue) is apatient medical exam glovewhich is a disposable deviceintended for medical purposethat is worn on the examiner'shand or finger to preventcontamination betweenexaminer and patient.It is also tested to be usedagainst chemotherapy drugsand Fentanyl Citrate | The device is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer.These gloves were testedfor use withchemotherapy drugs andFentanyl listed on thelabel. | Same asK200581 |
| Material | Nitrile | Nitrile | Nitrile | Same |
{7}------------------------------------------------
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
| Powder orPowder Free | Powder Free | Powder Free | Powder Free | Same |
|---|---|---|---|---|
| Color | Blue | Blue | Blue | Same |
| Single use | Single use | Single use | Single use | Same |
| ChemotherapyDrugs andFentanyl CitrateClaim | See below comparisontable | See below comparison table | See below comparisontable | / |
| BiodegradationProperties | Biodegradable | Biodegradable | / | Same asK200581 |
- QDO 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.
Technological Characteristic Comparison Table:
| TechnologicalCharacteristics | SubjectDeviceK231643 | Predicate DeviceK200581 | Reference DeviceK221269 | Comparison |
|---|---|---|---|---|
| Physical Dimension | ||||
| Length | Minimum 220mm forsizes XS and S,230mm for size M-XXL | Minimum 220mm forsizes XS and S,230mm for size M-XXL | Minimum 220mmfor sizes XS and S,230mm for size M-XXL | Same |
| Palm Width (size) (mm) | ||||
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | 130±10 | Same |
| Thickness(mm) | ||||
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Physical Property | ||||
| Tensile Strength, BeforeAging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,Before Aging | 500%, min | 500%, min | 500%, min | Same |
| Tensile Strength, AfterAccelerated Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
{8}------------------------------------------------
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
| Ultimate Elongation, AfterAccelerated Aging | 400%, min | 400%, min | 400%, min | Same |
|---|---|---|---|---|
| Watertight (1000ml) | G-I, AQL2.5 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| In vitro CytotoxicityISO 10993-5 | The test article extractshowed potentialtoxicity to L929 cells. | N/A | The test articleextract showedpotential toxicity toL929 cells. | Same asK221269 |
| Acute Systemic Toxicity TestISO 10993-11 | Under the conditions ofthis study, the deviceshowed no evidence ofacute systemic toxicity | Under the conditionsof this study, thedevice showed noevidence of acutesystemic toxicity | Under theconditions of thisstudy, the deviceshowed no evidenceof acute systemictoxicity | Same |
| Dermal SensitizationISO 10993-10 | Under the conditionsof the study, the deviceis not a sensitizer | Under the conditionsof the study, the deviceis not a sensitizer | Under theconditions of thestudy, the device isnot a sensitizer | Same |
| Primary Skin IrritationISO 10993-23 | Under the conditions of the study, the device isnot an irritant | Under the conditionsof the study, the deviceis not an irritant | Under theconditions of thestudy, the deviceis not an irritant | Same |
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum Breakthrough Detection Time(Minutes) | Comparison | ||
|---|---|---|---|---|
| Subject DeviceK231643 | Predicate DeviceK200581 | Reference DeviceK221269 | ||
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 | >240 | / | Same asK200581 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | / | >240 | Same asK221269 |
| Busulfan 6mg/ml (6,000 ppm) | >240 | / | >240 | Same asK221269 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 12.9 | 21.4 | 11.1 | Similar |
| Chloroquine 50mg/ml (50,000ppm) | >240 | / | >240 | Same asK221269 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same asK221269 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same asK221269 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | / | >240 | Same asK221269 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | / | >240 | Same asK221269 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | / | >240 | Same asK221269 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | / | >240 | Same asK221269 |
| Melphalan, 5mg/ml (5,000ppm) | >240 | / | >240 | Same asK221269 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | / | >240 | Same asK221269 |
| Retrovir, 10mg/ml (10,000ppm) | >240 | / | >240 | Same asK221269 |
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | >240 | Same asK221269 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 | 67.2 | 21.6 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | >240 | / | >240 | Same asK221269 |
| Trisenox, 1mg/ml (1,000ppm) | >240 | / | >240 | Same asK221269 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | / | >240 | Same asK221269 |
| Vincristine Sulfate (Oncovin), 1mg/ml(1,000ppm) | >240 | >240 | >240 | Same |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 | >240 | / | Same asK200581 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | Same |
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No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
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No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling.
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 | Minimum 220mm for sizes XS and S, 230mm for size M-XXL | Pass |
| ASTM D6319- 19 | Physical Dimensions Palm Width | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL: 120±10mmXXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 Mpa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer the above table in Section 5 | Pass |
| ISO 10993-10 &23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
| ISO 11737-1:2018 | Open box bioburden study | There is no increase in bioburden levels | Pass |
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 2017), 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 Resistance of Medical Gloves to Permeation by
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No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
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 ●
- . ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products.
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.