(126 days)
The 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. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (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, Fentanyl Citrate and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.
The acceptance criteria for the Biodegradable Nitrile Powder Free Examination Gloves and their reported performance are detailed in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions - Length | Minimum 220mm for size XS and S; 230mm for Size M, L, XL, XXL | Pass |
| ASTM D6319-19 | 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 | Physical Dimensions - Thickness | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021) | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 Mpa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs, Fentanyl Citrate and select other drugs | Refer to the detailed tables for specific drugs and minimum breakthrough detection times (BDT) – generally >240 minutes for most drugs, with exceptions for Carmustine (11.8 min) and Thio Tepa (33.5 min) | Pass (Meets or exceeds specified BDTs, with noted exceptions) |
| ISO 10993-10 & 23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | Non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | Showed potential toxicity to L929 cells, but this difference does not raise different questions of safety and effectiveness compared to the predicate device. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | No evidence of acute systemic toxicity. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample sizes for each test mentioned (e.g., number of gloves tested for each specific drug permeation, or for physical properties). However, it references established ASTM and ISO standards for these tests. These standards typically define the sampling plans and statistical requirements for demonstrating compliance. The data provenance is derived from non-clinical laboratory testing (in-vitro studies) performed by the manufacturer or a contracted lab, rather than human test subjects or clinical data. There is no information on the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biological tests (e.g., ASTM D6319, ASTM D6978, ISO 10993 series). The "ground truth" for these tests is established by the well-defined methodologies and acceptance criteria outlined in these international standards, not by expert consensus on clinical findings.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers' opinions are combined to establish a ground truth. For the non-clinical performance testing of a medical device like examination gloves, the determination of compliance is based on objective measurements against established standard criteria, not on adjudicating expert opinions.
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
This section is not applicable. No MRMC study was conducted as this device is an examination glove, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is an examination glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these gloves is based on standardized test methodologies and their defined acceptance criteria. This includes:
- Physical performance standards: ASTM D6319-19 for mechanical properties like length, palm width, thickness, tensile strength, and elongation.
- Leakage detection standards: ASTM D5151-19 for watertight integrity.
- Chemical permeation standards: ASTM D6978-05 (2019) for breakthrough detection time of chemotherapy drugs and other chemicals.
- Biocompatibility standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).
These standards provide objective, measurable criteria for the device's performance.
8. The sample size for the training set
This section is not applicable. The document describes the non-clinical performance testing of a physical medical device (examination gloves), not an AI or machine learning model. Therefore, there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this device.
{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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 4, 2023
Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K231567
Trade/Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (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: September 5, 2023 Received: September 5, 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 (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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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).
Sincerely,
Image /page/1/Picture/7 description: The image shows the text "Allan Guan -S" in a large, sans-serif font. The text is black and appears to be the main focus of the image. The background is plain, with a faint watermark-like design that is barely visible behind the text.
For Bifeng Qian, M.D., Ph.D. Assistant Director
{2}------------------------------------------------
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) K231567
Device Name
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Indications for Use (Describe)
The 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. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.
| Chemotherapy Drugs | Minimum Breakthrough Detection Time (BDT) in 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) | 11.8 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 33.5 |
| 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 |
Fentanyl citrate & other drugs Fentanyl Citrate Injection (100mcg/2mL) Minimum Breakthrough Detection Time (BDT) in Minutes
{4}------------------------------------------------
| Chloroquine 50mg/ml (50,000ppm) | >240 |
|---|---|
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.8 minutes, Thio Tepa: 33.5 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
of this information collection, including suggestions for reducing this burden, to:
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
The assigned 510(K) numbers: K231567
Date Prepared: October 4, 2023
1. Owner's Identification:
Mrs. Zhu Chunyan Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Tel:86-311-66179668 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:909-590-1611 Email: janicema@hongrayusa.com or fdareg(@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (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 and Reference 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, Fentanyl Citrate and select other drugs (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, Fentanyl Citrate and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The glove has biodegradation property within landfills tested per ASTM D5511.
5. Indications for Use:
The 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. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978. The following chemicals have been tested with these gloves:
{6}------------------------------------------------
| Chemotherapy Drug | Minimum Breakthrough Detection Time(BDT) in 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) | 11.8 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 33.5 |
| 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 |
| Fentanyl citrate & other drugs | Minimum Breakthrough Detection Time(BDT) in Minutes |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
{7}------------------------------------------------
*Please note that the following drugs have extremely low permeation times: Carmustine: 11.8 minutes, Thio Tepa: 33.5 minutes Warning: Do not use with Carmustine and Thio Tepa.
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, and select other drugs of the proposed and predicate devices. General Comparison Table:
| Subject DeviceK231567 | Predicate DeviceK200581 | Comparison | |
|---|---|---|---|
| Trade Name | Biodegradable Nitrile Powder FreeExamination Gloves Tested forUse with Chemotherapy Drugs ,Fentanyl Citrate, and select otherdrugs (Blue) | Biodegradable Nitrile Powder FreeExamination Gloves Tested for Usewith Chemotherapy Drugs andFentanyl Citrate (Blue) | Same |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC,QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. Inaddition these gloves weretested for use withChemotherapy drugs, FentanylCitrate, and select other drugsin accordance with ASTMD6978. | Biodegradable Nitrile Powder FreeExamination Gloves Tested for Usewith Chemotherapy Drugs andFentanyl Citrate (Blue) is a non-steriledisposable device intended for medicalpurpose that is worn on the examiner'shand to prevent contamination betweenexaminer and patient.It is also tested to be used againstchemotherapy drugs and FentanylCitrate | Different* |
| Material | Nitrile | Nitrile | Same |
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Chemotherapy Drugs,Fentanyl Citrate andother drugs Claim | See below comparisontable | See below comparison table | / |
| TechnologicalCharacteristics | Subject DeviceK231567 | Predicate DeviceK200581 | Comparison |
| Length | Meets ASTM D6319Minimum 220mm for size XSand S; 230mm for Size M, L, XL,XXL | Meets ASTM D6319Minimum 220mm for sizeXS and S; 230mm for SizeM, L, XL, XXL | Same |
| Palm Width (size) (mm) | Meets ASTM D6319 | Meets ASTM D6319 | Same |
| 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) | Meets ASTM D6319 | Meets ASTM D6319 | Same |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before Aging | Meets ASTM D631914MPa, min | Meets ASTM D631914MPa, min | Same |
| Ultimate Elongation,Before Aging | Meets ASTM D6319500%, min | Meets ASTM D6319500%, min | Same |
| Tensile Strength, AfterAccelerated Aging | Meets ASTM D631914MPa, min | Meets ASTM D631914MPa, min | Same |
| Ultimate Elongation, AfterAccelerated Aging | Meets ASTM D6319400%, min | Meets ASTM D6319400%, min | Same |
| Watertight (1000ml) | Meets ASTM D631921 CFR 800.20ASTM D5151 | Meets ASTM D631921 CFR 800.20ASTM D5151 | Same |
| Powder-Content | Meets ASTM D6319≤2 mg per glove | Meets ASTM D6319≤2 mg per glove | Same |
| In vitro CytotoxicityISO 10993-5 | The test article extract showedpotential toxicity to L929 cells. | NA | Different* |
| Dermal SensitizationISO 10993-10 | Under the conditions of thestudy, the test article extractshowed no significantevidence of causing skinsensitization | Under the conditions of thestudy, the device is not asensitizer | Same |
| Acute Systemic Toxicity TestISO 10993-11 | Under the conditions of thisstudy, the device showed noevidence of acute systemictoxicity | Under the conditions of thisstudy, the device showed noevidence of acute systemictoxicity | Same |
| Primary Skin IrritationISO 10993-23 | Under the conditions of thestudy, the device is not anirritant | Under the conditions of thestudy, the device is not anirritant | Same |
| Shelf-Life ExpiryASTM D7160-16 | 3 Years | 3 Years | Same |
| ASTM D5511-18 biodegradableProperties | biodegradable | biodegradable | Different** |
*This different is support with test report and will be indicated on labeling. So the differences do not impact the safety, effectiveness, and substantial equivalence of the subject device compared to the predicate.
Technological Characteristic Comparison Table:
{8}------------------------------------------------
{9}------------------------------------------------
*The Biocompatibility testing was successfully completed for the subject device, demonstrating that the difference does not raise different questions of safety and effectiveness and does not affect the substantial equivalence in effectiveness and safety.
**Biodegradability of subject device will be indicated on labeling and it is not a medical claim and therefore was not reviewed by FDA.
Chemotherapy Permeation Comparison:
| Tested Chemotherapy Drug andConcentration | SubjectDeviceK231567 | PrimaryPredicateDeviceK200581 | ReferenceDeviceK221269 | Comparison |
|---|---|---|---|---|
| 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) | 11.8 | 21.4 | 11.1 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| 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 |
{10}------------------------------------------------
| 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | >240 | Same asK221269 |
| Thio Tepa, 10mg/ml (10,000ppm) | 33.5 | 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 and Select Other Drugs Permeation Comparison
| Fentanyl citrate & other drugs | Minimum Breakthrough Detection Time(BDT) in Minutes | Comparison | ||
|---|---|---|---|---|
| SubjectDevice | PredicateDevice | ReferenceDevice | ||
| K231567 | K200581 | K221269 | ||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | / | >240 | Same asK221269 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same asK221269 |
| Retrovir, 10mg/ml (10,000ppm) | >240 | / | >240 | Same asK221269 |
Chemotherapy drugs and chemical as their minimum breakthrough time of subject device and "Gloves used for protection against chemotherapy drug exposure should be selected specifically for the type of chemicals used" will be listed on labeling, so the differences do not impact the safety, effectiveness, and substantial equivalence of the subject device compared to the predicate.
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 | Minimum 220mm for size XSand S; 230mm for Size M, L, XL,XXL | Pass |
| ASTM D6319- 19 | Physical DimensionsPalm Width | XS: 70 $\pm$ 10mmS: 80 $\pm$ 10mmM: 95 $\pm$ 10mmL:110 $\pm$ 10mmXL: 120 $\pm$ 10mm | Pass |
{11}------------------------------------------------
| 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 (Min 14 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,Fentanyl Citrate andselect other drugs | Refer the above table 1 | Pass |
| ISO 10993-10 &23:2021 | Irritation and SkinSensitization | Skin sensitization and Skinirritation | Is non-sensitization andNon-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potentialtoxicity to L929 cells. |
| 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 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 23: 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 ●
- Biodegradability is not a medical claim and therefore was not reviewed by FDA
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.