(102 days)
The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device, Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against specific ASTM standards for various properties and against a predicate device (K163146) for comparison. The key acceptance criteria and reported performance for critical aspects are as follows:
| Acceptance Criteria (Standard / Property) | Specific Requirement (as per standard) | Proposed Device Performance | Met Criteria? |
|---|---|---|---|
| Chemotherapy Drug Permeation | Breakthrough Detection Time: > 240 minutes for most drugs, except where noted by predicate | Varies per drug (see table below) | Met for most, not for Carmustine and Thiotepa (but disclosed) |
| Dimension (Length) | >= 230 mm (min) | 230 mm (all sizes) | Yes |
| Dimension (Width) | Varies per size (e.g., 70-120 mm) ±10 | Matches requirement | Yes |
| Dimension (Thickness - Finger) | 0.07 mm ±0.02 (for proposed) | 0.07 mm ±0.02 (specified) | Yes (meets own spec) |
| Dimension (Thickness - Palm) | 0.05 mm (min, for proposed) | 0.05 mm (specified) | Yes (meets own spec) |
| Dimension (Thickness - Cuff) | 0.05 mm ±0.02 (for proposed) | 0.05 mm ±0.02 (specified) | Yes (meets own spec) |
| Tensile Strength (Before Aging) | 15 MPa, min (ASTM D6319) | 15 MPa, min | Yes |
| Ultimate Elongation (Before Aging) | 500% min (ASTM D6319) | 500% min | Yes |
| Tensile Strength (After Aging) | 14 MPa, min (ASTM D6319) | 14 MPa, min | Yes |
| Ultimate Elongation (After Aging) | 400% min (ASTM D6319) | 400% min | Yes |
| Detection of Holes | Not detected (ASTM D5151) | Not detected | Yes |
| Powder Content | Max. 0.35 mg per glove (specified for proposed, meets ASTM D6319) | Max. 0.35 mg per glove | Yes (meets own spec) |
| Biocompatibility (Irritation) | Not an irritant (ISO 10993-10) | Not an irritant | Yes |
| Biocompatibility (Sensitization) | Not a sensitizer (ISO 10993-10) | Not a sensitizer | Yes |
| Biocompatibility (In Vitro Cytotoxicity) | Not cytotoxic (ISO 10993-5) | Not cytotoxic | Yes |
Chemotherapy Drug Permeation Performance and Acceptance Criteria (from tables on pages 2 and 5-6):
The acceptance criterion for chemotherapy drug permeation is generally a breakthrough detection time of >240 minutes, as demonstrated by most drugs. However, for Carmustine and Thiotepa, lower breakthrough times are explicitly noted and acknowledged. The device performance for these drugs is compared against the general expectation and specific values are provided.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes (Reported Device Performance) | Acceptance Criteria Met? (Based on general >240 min, or specific disclosure for lower times) |
|---|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 | Yes |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 | Yes |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 | Yes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 (12.7, 13.4, 8.5) (Noted as having low permeation time) | Yes (Disclosed and acceptable with warning) |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 | Yes |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 | Yes |
| Cytovene | 10 mg/ml (10,000ppm) | >240 | Yes |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 | Yes |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 | Yes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | >240 | Yes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 | Yes |
| Ellence | 2 mg/ml (2,000ppm) | >240 | Yes |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 | Yes |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 | Yes |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 | Yes |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 | Yes |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 | Yes |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 | Yes |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 | Yes |
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Melphalan | 5 mg/ml (5,000ppm) | >240 | Yes |
| Methotrexate | 25mg/ml (25,000ppm) | >240 | Yes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 | Yes |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 | Yes |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 | Yes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 | Yes |
| Rituximab | 10 mg/ml(10,000ppm) | >240 | Yes |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 (51.2, 36.1, 45.6) (Noted as having low permeation time) | Yes (Disclosed and acceptable with warning) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 | Yes |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each specific test. However, it indicates that "Bench tests were conducted to verify that the proposed device met all specifications."
- Sample Size: Not explicitly stated as a numerical value for each test. The adherence to standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978, ISO 2859-1, ISO 10993-10, and ISO 10993-5 implies that appropriate sample sizes, as dictated by these standards, were used for testing various properties (e.g., AQL for holes, specific number of samples for mechanical properties and chemical permeation). ISO 2859-1 specifically relates to "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," indicating a quality control sampling approach for certain attributes.
- Data Provenance: The tests were non-clinical bench tests conducted to evaluate the physical, performance, and biocompatibility characteristics of the gloves. The country of origin for the manufacturing company is China (Hebei Titans Hongsen Medical Technology Co., LTD.). The submission is for a medical device (gloves), and the testing appears to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO). The "ground truth" here is the pass/fail criteria defined by these objective engineering and material science standards, not subjective human interpretations or expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective, standardized test methods with clear pass/fail criteria, not on subjective expert review requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This submission is for a medical device (gloves) and does not involve AI or human readers for diagnostic or interpretive tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This submission is not for an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established scientific and engineering standards and their predefined pass/fail criteria. These include:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties).
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05: Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical permeation).
- ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- ISO 10993-10: 2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
- ISO 10993-5:2009: Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
The performance values obtained from the actual testing of the gloves are compared directly against the quantitative limits set forth in these standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Hebei Titans Hongsen Medical Technology Co., LTD. % Ray Wang General Manager Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn
Re: K181130
Trade/Device Name: Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: July 16, 2018 Received: July 20, 2018
Dear Ray Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181130
Device Name
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with proposed device.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 (12.7, 13.4, 8.5) |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 |
| Cytovene | 10 mg/ml (10,000ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 |
| Ellence | 2 mg/ml (2,000ppm) | >240 |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 |
| Melphalan | 5 mg/ml (5,000ppm) | >240 |
| Methotrexate | 25mg/ml (25,000ppm) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 |
| Rituximab | 10 mg/ml(10,000ppm) | >240 |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 (51.2, 36.1, 45.6) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 |
*Please note that the following drugs have low permeation times:
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
The assigned 510(k) Number: K181130
-
- Date of Preparation: 08/03/2018
-
- Sponsor Identification
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD. EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA
Contact Person: Mr. ShaoZhang Nan Tel: +86-0319-7295820 Fax: +86-0319-7295801 Email: nanshaozhang@163.com
- Designated Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558, Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com
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4. Proposed Device Identification
Trade Name: Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
Device Name: NITRILE Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves
Regulatory Information Classification: I Product Code: LZA, LZC Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication for Use:
The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with proposed device.
| Chemotherapy DrugDetection Time in Minutes | Concentration | Breakthrough Minutes |
|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 |
| Cisplatin | 1.0 mg/ml (1,000ppm) | (12.7,13.4, 8.5) |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 |
| Cytovene | 10 mg/ml (10,000ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 |
| Docetaxel | 10.0 mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 |
| Ellence | 2 mg/ml (2,000ppm) | >240 |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 |
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| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 |
|---|---|---|
| Melphalan | 5 mg/ml (5,000ppm) | >240 |
| Methotrexate | 25mg/ml (25,000ppm) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 |
| Rituximab | 10 mg/ml(10,000ppm) | >240 |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1(51.2,36.1, 45.6) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 |
*Please note that the following drugs have low permeation times: Carmustine (BCNU): 8.5 minutes and Thiotepa: 36.1 minutes
5. Predicate Device Identification
510(k) Number: K163146
Product Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD.
- Device Description 6.
The proposed device, Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
The proposed device was tested according to the following standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05. These standards are identified in the following section "Non-clinical test conclusion.
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7. Technological Comparison Tables
| Item | Proposed Device (K181130) | Predicate Device (K163146) | Remark |
|---|---|---|---|
| Product Code | LZA, LZC | LZA, LZC | SAME |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended use | The Powder Free Blue NitrileExamination Gloves, Testedfor Use with ChemotherapyDrugs is a disposable deviceintended for medical purposesthat is worn on the examiner'shands to preventcontamination betweenpatient and examiner. | The POWDER FREE BlueNitrile GLOVES, Tested forUse with Chemotherapy Drugsis a disposable device intendedfor medical purposes that isworn on the examiner's handsto prevent contaminationbetween patient and examiner. | SAME |
| Design Feature | ambidextrous | ambidextrous | SAME |
| LabelingInformation | Single-use indication, powderfree, device name, glove sizeand quantity, NitrileExamination Gloves, Non-Sterile | Single-use indication, powderfree, device name, glove sizeand quantity, NitrileExamination Gloves, Non-Sterile | SAME |
| ChemotherapyDrugPermeationClaim | Bleomycin, Busulfan,Carboplatin, Carmustine(BCNU), Cisplatin,Cyclophosphamide(Cytoxan),Cytarabine, Cytovene,Dacarbazine(DTIC) ,Daunorubicin, Docetaxel,Doxorubicin, Hydrochloride,Ellence, toposide(Toposar),Fludarabine, Fluorouracil,Gemcitabine (Gemzar),Idarubicin, Ifosfamide,Irinotecan, MechlorethamineHCI, Melphalan,Methotrexate, Mitomycin C,Mitoxantrone, Oxaliplatin,Paclitaxel (Taxol), Rituximab,Thiotepa, Trisenox,Vincristine Sulfate, | Fluorouracil, Etoposide(Toposar), Cyclophosphamid(Cytoxan), Carmustine(BCNU), Thiotepa, Paclitaxel(Taxol), DoxorubicinHydrochloride, Dacarbazine(DTIC), Cisplatin, Carboplatin,Docetaxel, Ifosfamide,Irinotecan, MechlorethamineHCL, Methotrexate,Mitomycin C, Mitoxantrone,Vincristine Sulfate | Different |
Table 1 General Comparison
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| Proposed Device (K181130) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Length,mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width,mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.07 | ±0.02 | |||||
| Palm | 0.05 | min | |||||
| Cuff | 0.05 | ±0.02 | |||||
| Predicate Device (K163146) | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length,mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width,mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.10 | ±0.03 | |||||
| Palm | 0.08 | ±0.03 | |||||
| Cuff | 0.06 | ±0.03 | |||||
| Remark | Different |
Table 2 Device Dimensions Comparison
Table 3 Performance Comparison
| Item | Proposed Device (K181130) | Predicate Device(K163146) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | Blue | Similar | ||
| Physicalproperties | BeforeAging | TensileStrength | 15 Mpa, min | 15 Mpa, min | SAME |
| UltimateElongation | 500% min | 500% min | |||
| AfterAging | TensileStrength | 14 MPa, min | 14 MPa, min |
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| UltimateElongation | 400% min | 400% min | ||
|---|---|---|---|---|
| Comply with ASTM D6319 | Comply with ASTMD6319 | SAME | ||
| Detection of Holes | Not detected, in accordance withASTM D5151 | Not detected, inaccordance withASTM D5151 | SAME | |
| Powder Content | Max. 0.35 mg per glove | Max. 0.32 mg perglove | Different |
Table 4 Safety Comparison
| Item | Proposed Device(K181130) | Predicate Device (K163146) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Irritation | Under the conditionsof the study, not anirritant | Under the conditions of the study,not an irritant | ||
| Biocompatibility | Sensitization | Under the conditionsof the study, not asensitizer | Under the conditions of the study,not a sensitizer | Similar |
| In VitroCytotoxicity | Under the conditionsof the study, notcytotoxic | / |
Different Analysis:
- The proposed device has different chemotherapy drug permeation claim to the predicate device.
The chemotherapy drug permeation results for the proposed device meets the specifications of ASTM D6978 except for Carmustine and Thiotepa.
-
The proposed device has different thickness specification to the predicate device, but all thickness of proposed devices meets the specifications of ASTM D 6319.
-
The proposed device has different powder content to the predicate device, but all powder content of proposed devices meets the specifications of ASTM D 6319.
8. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all specifications. The test results demonstrated that the proposed device complies with the following standards:
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical ●
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Application.
- . ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on ● Medical Gloves.
- . ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
- . ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation ● and skin sensitization.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
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- Clinical Test Conclusion
No clinical study is included in this submission.
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- Comparison 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.
- Comparison Conclusion
§ 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.