(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)
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, 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 provided document describes the acceptance criteria and performance of "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It is important to note that this is a 510(k) summary for a medical device (gloves), not an AI/algorithm-driven device. Therefore, many of the requested fields related to AI clinical studies, such as sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.
The studies described are non-clinical performance tests for the gloves themselves, not an AI system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions - Length (ASTM D6319-19) | Min 220mm for size XS, S; Min 230mm for size M-XXL | Pass |
| Physical Dimensions - Palm Width (ASTM D6319-19) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm; XXL: 130±10 mm | Pass |
| Physical Dimensions - Thickness (ASTM D6319-19) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min and After Accelerated Aging 400% min) | Pass |
| Water Leak Test (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 (ISO 2859-1) | Pass |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2mg/glove | Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | Refer to the detailed table (reproduced below) | Pass |
| Irritation and Skin Sensitization (ISO 10993-10:2010) | Is non-sensitization and non-irritation | Is non-sensitization and Non-irritation |
| Cytotoxicity (ISO 10993-5:2009) | Cytotoxicity reactivity | showed potential toxicity to L929 cells (Note: addressed by acute systemic toxicity testing) |
| Acute Systemic Toxicity Study (ISO 10993-11:2017) | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity |
Detailed Chemotherapy Drug Permeation and Fentanyl Citrate Comparison Claim (Subject device K232266 performance):
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 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 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Warning: Do not use with Carmustine (22.8 minutes) and Thiotepa (46.9 minutes).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "sample sizes" for the test set in terms of medical images or patient data. Instead, it refers to standardized testing methodologies for physical and chemical properties of gloves. For instance, ASTM D5151 for water leak test would involve a certain number of gloves per batch as per AQL (Acceptable Quality Limit) standards, but the specific quantity is not stated in this summary. The data provenance is generally implied to be from laboratory testing conforming to the cited ASTM and ISO standards. The country of origin of the device manufacturer is China. These are prospective tests performed on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or patient data. The "ground truth" for the device's performance is established by the specified pass/fail criteria of the ASTM and ISO standards for glove manufacturing and material properties. The tests are laboratory-based and measure physical/chemical attributes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic or screening studies, not for the physical and chemical testing of medical gloves.
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
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on standardized test methods and predetermined acceptance criteria defined by international and national standards organizations such as ASTM and ISO. These standards dictate acceptable physical dimensions, mechanical properties, chemical permeation resistance, and biological safety (e.g., irritation, sensitization, systemic toxicity) for medical examination gloves. For instance, for chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time according to ASTM D6978-05(2019).
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no "training set" or ground truth established in that context.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
November 3, 2023
Better Care Plastic Technology Co., Ltd. Zhu Chunyan General Manager Fuqian Xi Road, West district of Shenze Industrial Base Shenze County, Hebei 050000 China
Re: K232266
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ Dated: October 24, 2023 Received: October 24, 2023
Dear Zhu Chunyan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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).
{2}------------------------------------------------
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Bifeng Qian -S" in a simple, sans-serif font. The text is black against a white background, making it easily readable. The name appears to be a personal name, possibly indicating an individual's identity or a product/brand name.
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery 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) K232266
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 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 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
{4}------------------------------------------------
Please note that the following drugs have extremely low permeation times: Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes, *Warning: Do not use with Carmustine and Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
The assigned 510(K) numbers: K232266
Date Prepared: November 02, 2023
1. Owner's Identification:
Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Contact: Ms. Zhu chunyan / General Manager Tel:909-590-1611 Email: janicema@hongrayusa.com or fdareg@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, ODO, 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 Fentanyl Citrate (K221269)
4. Device Description:
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, 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.
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)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) inMinutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
The following Chemotherapy Drugs have been tested with these gloves:
{6}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 |
|---|---|
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 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 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Please note that the following drugs have extremely low permeation times:
Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes, Or
*Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of technological characteristics between the subject device with the legally marketed K221269:
| Subject DeviceK232266 | Predicate DeviceK221269 | Comparison | |
|---|---|---|---|
| Trade Name | Powder Free Nitrile Patient | Powder Free Nitrile Examination | Similar |
| Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Glove (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | ||
| 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 device 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 | The device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl listed on the label. | Same |
| Material | Nitrile | Nitrile | Same |
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| 10993-10:2010 SkinIrritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same |
| 10993-10:2010MaximizationSensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| 10993-5:2009Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. Cytotoxicity concern was addressed by acute systematic toxicity testing. | Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. Cytotoxicity concern was addressed by acute systematic toxicity testing. | Same |
| ISO 10993-11:2017Acute Systemictoxicity study | Under the conditions of this study, there was no evidence of acute systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. | Same |
| Chemotherapy Drugs and Fentanyl Citrate Claim | See below comparison table | See below comparison table | Same |
| TechnologicalCharacteristics | Subject DeviceK232266 | Predicate DeviceK221269 | Comparison |
| Physical Dimension | |||
| Length | Min 220mm for size XS, SMin 230mm for size M-XXL | Min 220mm for size XS, SMin 230mm for size M-XXL | Same |
| Palm Width (size) (mm) | |||
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XL | 130±10 | 130±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Physical Property | |||
| Tensile Strength, Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, BeforeAging | 500%, min | 500%, min | Same |
| Tensile Strength, AfterAccelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, AfterAccelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20ASTM D5151 | 21 CFR 800.20ASTM D5151 | Same |
| Powder-Content | <2 mg per glove | <2 mg per glove | Same |
{7}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
- QDO and OPJ, are designated for Medical Gloves with Fentanyl Citrate and Chemotherapy Labeling Claims. The subject device has added the product code OPJ as per requirements but does not raise questions of safety and effectiveness.
{8}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
Technological Characteristic Comparison Table:
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Comparison | |
|---|---|---|---|
| Subject DeviceK232266 | Predicate DeviceK221269 | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | Same |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 | 11.1 | Similar |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 | >240 | Same |
{9}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | >240 | Same |
|---|---|---|---|
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | Same |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Melphalan, 5mg/ml (5,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | >240 | Same |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 | 21.6 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Trisenox, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Velcade, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
- Chemotherapy drugs and Fentanyl Citrate and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.
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 DimensionsLength | Min 220mm for size XS, SMin 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical DimensionsPalm Width | XS: $70\pm10$ mmS: $80\pm10$ mmM: $95\pm10$ mm | Pass |
{10}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
| L:110±10mm | |||
|---|---|---|---|
| XL:120±10mm | |||
| XXL:130±10mm | |||
| ASTM D6319- 19 | Physical DimensionsThickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 MPa)and Elongation (Before Aging500% 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 byChemotherapy Drugs | Refer above table | Pass |
| ISO 10993-10:2010 | Irritation and SkinSensitization | Skin sensitization and Skinirritation | Is non-sensitizationand Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potentialtoxicity to L929cells. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | no evidence of acutesystemic toxicity. |
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (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 Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation . Sensitization.
- 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
Not applicable.
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 predicated 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.