(204 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.
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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, 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. The gloves are single use, disposable, and provided non-sterile.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).
Non-Clinical Performance Data
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions (Length) | Min 220mm for size XS, S; Min 230mm for size M-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 | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min 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 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | As specified in the table for each drug (e.g., >240 minutes for most, with specific lower values for Carmustine and Thiotepa, explicitly stating "Do not use" for these). | Pass (as per specific BDTs) |
| ISO 10993-5:2009 | Cytotoxicity | No cytotoxicity reactivity (Note: The device states it is cytotoxic but this concern was addressed by acute systemic toxicity testing.) | The test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No skin sensitization and Skin irritation | Under the conditions of this study, there were no evidence of sensitization and irritation. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic toxicity. |
Clinical Performance Data
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Modified DRAIZE-95 Test to Evaluate Low Dermatitis Potential of Medical Gloves | Demonstrate a reduced potential for sensitizing users to chemical additives. | Under the conditions of this clinical trial, the subject device demonstrated reduced potential for sensitizing users to chemical additives. |
Study Information
Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.
Here's what can be extracted from the document:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
- Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
- Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
- Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
- For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
- For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.
-
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 device is a physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
- Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
- Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.
-
The sample size for the training set:
- Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.
-
How the ground truth for the training set was established:
- Not applicable. As above, this is for an algorithm or machine learning model.
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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2025
Better Care Plastic Technology Co., Ltd. Chunyan Zhu General Manager Fugian Xi Road, West district of Shenze Industrial Base Shenze County, Hebei 050000 China
Re: K242533
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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: August 20, 2024 Received: August 26, 2024
Dear Chunyan Zhu:
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/cdrb/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}------------------------------------------------
Page 2
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 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatory
{2}------------------------------------------------
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ALLAN GUAN-S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K242533
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatits Potential. 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.
| 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, Do not use |
| 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 |
| 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9, Do not use |
| 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 & other drugs | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
{4}------------------------------------------------
| Retrovir, 10mg/ml (10,000ppm) | >240 |
|---|---|
| ------------------------------- | ------ |
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) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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{5}------------------------------------------------
510(k) Summary (As required by 21 CFR 807.92)
510K Summary
The assigned 510(K) numbers: K242533
Date Prepared: March 17, 2025
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. Chunyan Zhu / General Manager Tel:86-311-66179668 Email:ffdareg@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266)
4. Device Description:
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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, 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. 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.
| 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 |
The following Chemotherapy Drugs have been tested with these gloves:
{6}------------------------------------------------
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8, Do not use |
|---|---|
| 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 |
| 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9, Do not use |
| 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 and other drugs | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
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.
6. Comparison of subject device and Predicate Device:
General Comparison Table:
| Subject DeviceK242533 | Predicate DeviceK232266 | ComparisonResult | |
|---|---|---|---|
| Trade Name | Powder Free Nitrile PatientExamination Gloves, Blue Colored, | Powder Free Nitrile PatientExamination Gloves, Blue Colored, | Different* |
| Non-Sterile, Low DermatitisPotential. Tested for Use withChemotherapy Drugs and FentanylCitrate | Non-Sterile, Tested for Use withChemotherapy Drugs and FentanylCitrate | ||
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The glove is a disposable deviceintended for medical purposes thatis worn on the examiner's hand toprevent contamination betweenpatient and examiner. Gloves havebeen tested for use withchemotherapy drugs and FentanylCitrate using ASTM D6978-05. | The glove is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner. Gloves havebeen tested for use withchemotherapy drugs and FentanylCitrate using ASTM D6978-05 | Same |
| Material | Nitrile | Nitrile | Same |
| Powder or PowderFree | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| 10993-5:2009Cytotoxicity Test | The test article scored '4' at 24, 48,and 72 ± 4 hours and is consideredcytotoxic under the conditions ofthis test. Cytotoxicity concern wasaddressed by acute systemic toxicitytesting. | Under the conditions of this study,the test article extract showedpotential toxicity to L929 cells.Cytotoxicity concern was addressedby acute systemic toxicity testing. | Same |
| 10993-10:2010Skin Irritation Study | Under the conditions of the study,not an irritant | Under the conditions of the study,not an irritant | Same |
| 10993-10:2010Sensitization Study | Under the conditions of the study,not a sensitizer | Under the conditions of the study,not a sensitizer | Same |
| ISO 10993-11:2017Acute Systemictoxicity study | Under the conditions of this study,there was no evidence of acutesystemic toxicity. | Under the conditions of this study,there was no evidence of acutesystemic toxicity. | Same |
| Clinical test | Under the conditions of this clinicaltrial, the subject devicedemonstrated reduced potential forsensitizing users to chemicaladditives. | No Test | Different* |
| Chemotherapy Drugsand Fentanyl CitrateClaim | See below comparison table | See below comparison table | Same |
| TechnologicalCharacteristics | Proposed DeviceK242533 | Predicate DeviceK232266 | Result ofcomparison |
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Minimum 220mm for size XS and S, 230mm for size M, L, XL, 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 |
| XXL | 130±10 | 130±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, BeforeAging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,Before Aging | 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 D5151G-1, AQL 2.5 | 21 CFR 800.20ASTM D5151G-1, AQL 2.5 | Same |
| Powder-Content | < 2 mg per glove | < 2 mg per glove | Same |
{7}------------------------------------------------
*This different is support with test report, so this different does not raise questions of safety and effectiveness of subject device.
{8}------------------------------------------------
Technological Characteristic Comparison Table:
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Result ofcomparison | |
|---|---|---|---|
| Proposed DeviceK242533 | Predicate DeviceK232266 | ||
| 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 | 22.8 | Same |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| 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 |
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| 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 | 46.9 | Same |
| 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 and other drugs | Minimum BDT (Minutes) | Result of | |
|---|---|---|---|
| Proposed Device | Predicate Device | comparison | |
| K242533 | K232266 | ||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 | >240 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | Same |
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±10mmS: 80±10mmM: 95±10mmL:110±10mm | Pass |
{10}------------------------------------------------
| XL: 120±10mmXXL: 130±10mm | |||
|---|---|---|---|
| ASTM D6319- 19 | Physical DimensionsThickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16 | 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 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation byChemotherapy Drugs | Refer above table | Pass |
| ISO 10993-5:2009 | Cytotoxicity | No cytotoxicity reactivity | The test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-10:2010 | Irritation and SkinSensitization | No skin sensitization and Skin irritation | Under the conditions of this study, there were no evidence of sensitization and irritation |
| ISO 10993-11:2017 | Acute systemictoxicitystudy | No adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic 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, Standard Test Method for Residual Powder on Medical Gloves
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05, Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs. ●
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Irritation and Sensitization.
- . ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests For Acute systemic toxicity
8. Clinical Performance Data
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| Test | Description | Results |
|---|---|---|
| Modified DRAIZE-95Test to Evaluate LowDermatitis Potential ofMedical Gloves | A 305 subject study was completed to evaluatewhether the level of residual chemicaladditives in the subject device induced TypeIV allergic contact sensitization by repetitiveapplications to the skin of normal healthyhuman volunteers using the modified Draize-95 test as recommended by the FDA. | Under the conditions of thisclinical trial, the subject devicedemonstrated reduced potentialfor sensitizing users to chemicaladditives. |
9. Conclusion:
The conclusions drawn from the nonclinical and clinical 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.