(70 days)
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10(2015) and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2013).
This document is a 510(k) summary for the "Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". It describes the device, its intended use, and comparative testing against a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily evaluated against two standards: ASTM D6319-10(2015) for Nitrile Examination Gloves (General Characteristics) and ASTM D6978-05(2013) for Chemotherapy Drug Permeation. Specific acceptance criteria are not explicitly stated for all parameters, but rather the performance of the proposed device is compared to the predicate device and relevant ASTM standards.
The table below summarizes the key performance characteristics and reported results. For characteristics not explicitly having acceptance criteria listed as a specific number, the "Comparison" column indicates if the device is "Same" or "Similar" to the predicate, implying it meets comparable performance.
| Test Parameter / Acceptance Criteria (as per ASTM standards or comparison) | Reported Device Performance (Proposed Device K182600) |
|---|---|
| General Characteristics (ASTM D6319-10(2015)) | |
| Length | Minimum 230mm |
| Palm Width (XS) | $70\pm10$ mm |
| Palm Width (S) | $80\pm10$ mm |
| Palm Width (M) | $95\pm10$ mm |
| Palm Width (L) | $110\pm10$ mm |
| Palm Width (XL) | $120\pm10$ mm |
| Thickness (Finger) | Minimum 0.05 mm |
| Thickness (Palm) | Minimum 0.05 mm |
| Tensile Strength, Before Aging | 14MPa, min |
| Ultimate Elongation, Before Aging | 500%, min |
| Tensile Strength, After Accelerated Aging | 14MPa, min |
| Ultimate Elongation, After Accelerated Aging | 400%, min |
| Freedom from holes (ASTM D 5151-06, AQL 2.5) | In accordance with ASTM D 5151-06, following ASTM D6319-10, G-1, AQL 2.5 |
| Powder-Content | $\le2$ mg per glove |
| Biocompatibility (ISO 10993) | |
| ISO 10993-10:2010 Skin Irritation Study | Not an irritant |
| ISO 10993-10:2010 Maximization Sensitization Study | Not a sensitizer |
| ISO 10993-5:2009 Cytotoxicity Test | Not a cytotoxic potential |
| Chemotherapy Drug Permeation (ASTM D6978-05(2013)) | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or test replicates) used for each individual test (e.g., tensile strength, freedom from holes, chemotherapy permeation). It references the ASTM standards, which typically define the appropriate sample sizes and testing methodologies.
The data provenance is from non-clinical testing conducted by Better Care Plastic Technology Co., Ltd. located in Hebei Province, China. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation of these medical gloves relies on objective measurements performed according to recognized international standards (ASTM, ISO). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes for this type of device. The "truth" is established by the standardized test methods themselves and the resulting physical and chemical measurements.
4. Adjudication method for the test set
This information is not applicable. The tests performed are objective, quantitative measurements according to predefined standards. There is no subjective assessment requiring adjudication.
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 information is not applicable. This is a medical glove, a physical device, and not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is based on objective measurements derived from standardized test methods (ASTM D6319-10, ASTM D6978-05, ISO 10993 series). For example:
- Physical properties (e.g., tensile strength, elongation): Measured directly by testing equipment following ASTM protocols.
- Freedom from holes: Determined by a standardized water-leak test (ASTM D5151-06).
- Chemotherapy drug permeation: Measured by detecting the breakthrough of chemotherapy drugs through the glove material over time, as per ASTM D6978-05.
- Biocompatibility: Evaluated using established in-vitro and in-vivo biological tests (cytotoxicity, irritation, sensitization) according to ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of validating a medical glove. The product is manufactured and then tested to ensure it meets performance standards.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2018
Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc 3973 Schaefer Avenue, Chino, CA 91810, USA
Re: K182600
Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: September 16, 2018 Received: September 21, 2018
Dear Kathy Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.html; 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 mediation-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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Indications for Use
510(k) Number (if known) K182600
Device Name
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)
| Indications for Use (Describe) | |
|---|---|
| Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) 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 using ASTM D6978 and will be labeled with a statement of | |
| compliance and a summary of the testing results. | |
| Chemotherapy Drug Permeation | |
| The following chemicals have been tested with these gloves: | |
| Chemotherapy Drug | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
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- Please note that the following drugs have extremely low permeation times:
Carmustine: 11.0 minutes and Thiotepa: 28.8 minutes
Type of Use (Select one or both, as applicable)
7 Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
510(K) SUMMARY
The assigned 510(K) numbers: K182600 Date Prepared: November 18, 2018
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 Province, CHINA 0500000 Tel:86-311-66179653 Fax: 86-311-66179653
Contact: Ms. Kathy Liu, Project Manager or Ms Monica Yu Hongray USA Medical Products Inc. Address: 3973 Schaefer Avenue, Chino, CA 91810, USA Tel:909-590-1611 Fax: 909-673-8347
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) Common Name: Exam Gloves Classification Name: Non-powdered patient Examination Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Central Medicare Sdn. Bhd. Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942)
4. Device Description:
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-10(2015) and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2013).
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
510(K) SUMMARY
5. Indications for Use:
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) 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 using ASTM D6978-05(2013) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation
| Chemotherapy Drug | Minimum BreakthroughDetection Time (Minutes) |
|---|---|
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan (5.0mg/ml) | >240 |
The following chemicals have been tested with these gloves:
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
510(K) SUMMARY
| Mitomycin C, (0.5mg/ml) | >240 |
|---|---|
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine:
11.0 minutes and Thiotepa: 28.8 minutes
6. Technological Characteristic Comparison Table:
The proposed device will be known as Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue).
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices.
| Proposed Device K182600 | Predicate Device K173942 | Comparison | |
|---|---|---|---|
| Trade Name | Powder Free NitrileExamination Gloves,Tested for Use withChemotherapy Drugs(Blue) | Blue Non Sterile PowderFree Nitrile ExaminationGloves Tested for Usewith Chemotherapy Drugs | Similar |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
General Comparison Table:
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
| 510(K) SUMMARY | |||
|---|---|---|---|
| Indications for Use | Powder Free NitrileExamination Gloves,Tested for Use withChemotherapy Drugs(Blue) is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner. | Blue Non Sterile PowderFree Nitrile ExaminationGloves Tested for Usewith Chemotherapy Drugsis a disposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | Same |
| Powder or PowderFree | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Similar |
| LabelingInformation | Single-use indication,powder free, device name,glove size, quantity,Nitrile ExaminationGloves, Non Sterile | Single-use indication,powder free, device name,glove size, quantity,NitrileExamination Gloves,Non Sterile | Same |
| ChemotherapyDrugPermeation Claim | See below comparisontable | See below comparison table | Same |
Dimensions and Performance Comparison Table:
| TechnologicalCharacteristics | ProposedDeviceK182600 | PredicateDeviceK173942 | Comparison |
|---|---|---|---|
| Length | Minimum230mm | Minimum230mm | Same |
| Palm Width (size) (mm) | |||
| XS | $70\pm10$ | $70\pm10$ | Same |
| S | $80\pm10$ | $80\pm10$ | Same |
| M | $95\pm10$ | $95\pm10$ | Same |
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
510(K) SUMMARY
| L | 110±10 | 110±10 | Same |
|---|---|---|---|
| XL | 120±10 | 120±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | 0.10±0.03 | Similar |
| Palm | Minimum 0.05 | 0.08±0.03 | Similar |
| 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,After Accelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance withASTM D 5151-06,following ASTM D6319-10, G-1, AQL 2.5 | In accordance withASTM D 5151-06,following ASTM D6319-10, G-1, AQL 2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Similar |
| 10993-10:2010 SkinIrritation Study | Under the conditions ofthe study,not an irritant | Under the conditions ofthe study,not an irritant | Same |
| 10993-10:2010MaximizationSensitization Study | Under the conditions ofthe study,not a sensitizer | Under the conditions ofthe study,not a sensitizer | Same |
| 10993-5:2009Cytotoxicity Test | Under the conditions ofthis study, not a cytotoxicpotential | Under the conditions ofthis study, not a cytotoxicpotential | Same |
Chemotherapy Permeation Comparison:
| Minimum BDT (Minutes) | Comparison | ||
|---|---|---|---|
| Tested Chemotherapy Drugand Concentration | ProposedDeviceK182600 | PredicateDeviceK173942 | |
| Carmustine(BCNU) (3.3mg/ml) | 11.0 | 12.4 | Similar |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| Dacarbazine (DTIC) | >240 | >240 | Same |
| (10mg/ml) | |||
| Doxorubicin Hydrochloride(2mg/ml) | >240 | >240 | Same |
| Etoposide (Toposar)(20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Paclitaxel (Taxol) (6mg/ml) | >240 | >240 | Same |
| Thiotepa (THT) (10mg/ml) | 28.8 | 24.4 | Similar |
| Bleomycin (15.0mg/ml) | >240 | >240 | Same |
| Busulfan (6.0mg/ml) | >240 | >240 | Same |
| Carboplatin, (10.0mg/ml) | >240 | >240 | Same |
| Chloroquine, (50.0mg/ml) | >240 | >240 | Same |
| Cyclosporin, (100.0mg/ml) | >240 | >240 | Same |
| Cytarabine, (100.0mg/ml) | >240 | >240 | Same |
| Daunorubicin, (5.0mg/ml) | >240 | >240 | Same |
| Docetaxel, (10.0mg/ml) | >240 | >240 | Same |
| Epirubicin (Ellence),(2.0mg/ml) | >240 | >240 | Same |
| Fludarabine, (25.0mg/ml) | >240 | >240 | Same |
| Gemcitabine (Gemzar)(38.0mg/ml) | >240 | >240 | Same |
| Idarubicin, (1.0mg/ml) | >240 | >240 | Same |
| Ifosfamide, (50.0mg/ml) | >240 | >240 | Same |
| Irinotecan, (20.0mg/ml) | >240 | >240 | Same |
| Mechlorethamine HCI,(1.0mg/ml) | >240 | >240 | Same |
| Melphalan, (5.0mg/ml) | >240 | >240 | Same |
| Mitomycin C, (0.5mg/ml) | >240 | >240 | Same |
| Mitoxantrone, (2.0mg/ml) | >240 | >240 | Same |
| Oxaliplatin, (2.0mg/ml) | >240 | >240 | Same |
| Paraplatin, (10.0mg/ml) | >240 | >240 | Same |
| Retrovir, (10.0mg/ml) | >240 | >240 | Same |
| Rituximab, (10.0mg/ml) | >240 | >240 | Same |
| Topotecan HCL, (1.0mg/ml) | >240 | >240 | Same |
| Trisonex, (1.0mg/ml) | >240 | >240 | Same |
| Velcade (Bortezomib),(1.0mg/ml) | >240 | >240 | Same |
| Vincristine, (1.0mg/ml) | >240 | >240 | Same |
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510(K) SUMMARY
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Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
510(K) SUMMARY
7. Summary Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- 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
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves For Medical Application.
- . ASTM D6978-05 (Reapproved 2013), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
8. Summary of Clinical Testing
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 predicated device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.