(70 days)
Not Found
No
The device is a physical examination glove and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device, Powder Free Nitrile Examination Gloves, is intended to prevent contamination between the patient and the examiner, not to provide therapy or treatment. Its primary function is protection, especially from hazardous substances like chemotherapy drugs.
No
The device is described as "Powder Free Nitrile Examination Gloves...worn on the examiner's hand to prevent contamination between patient and examiner." Its intended use is for protection, not for diagnosing a condition or disease.
No
The device is a physical glove, not software. The description details material properties, dimensions, and physical testing, not software functions or algorithms.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties of the gloves (material, size, thickness, strength, resistance to chemicals) and their compliance with standards related to examination gloves and chemotherapy drug resistance. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples like blood, urine, tissue, etc., to diagnose, monitor, or screen for diseases or conditions. This device does not perform any such tests.
The testing mentioned (ASTM D6978) is to assess the glove's barrier properties against chemotherapy drugs, which is a performance characteristic of the device itself, not a diagnostic test on a patient sample.
N/A
Intended Use / 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 and will be labeled with a statement of compliance and a summary of the testing results.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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 |
3
- 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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4
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).
5
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 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 |
The following chemicals have been tested with these gloves:
6
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 Nitrile | ||
| Examination Gloves, | |||
| Tested for Use with | |||
| Chemotherapy Drugs | |||
| (Blue) | Blue Non Sterile Powder | ||
| Free Nitrile Examination | |||
| Gloves Tested for Use | |||
| with 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:
7
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
| 510(K) SUMMARY | |||
|---|---|---|---|
| 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. | Blue Non Sterile Powder | ||
| Free 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. | Same | ||
| Powder or Powder | |||
| Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Similar |
| Labeling | |||
| Informati | |||
| on | Single-use indication, | ||
| powder free, device name, | |||
| glove size, quantity, | |||
| Nitrile Examination | |||
| Gloves, Non Sterile | Single-use indication, | ||
| powder free, device name, | |||
| glove size, quantity, | |||
| Nitrile | |||
| Examination Gloves, | |||
| Non Sterile | Same | ||
| Chemotherapy | |||
| Drug | |||
| Permeation Claim | See below comparison | ||
| table | See below comparison table | Same |
Dimensions and Performance Comparison Table:
| Technological
Characteristics | Proposed
Device
K182600 | Predicate
Device
K173942 | Comparison |
|----------------------------------|-------------------------------|--------------------------------|------------|
| Length | Minimum
230mm | Minimum
230mm | Same |
| Palm Width (size) (mm) | | | |
| XS | $70\pm10$ | $70\pm10$ | Same |
| S | $80\pm10$ | $80\pm10$ | Same |
| M | $95\pm10$ | $95\pm10$ | Same |
8
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, Before | |||
| Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After | |||
| Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| After Accelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with | ||
| ASTM D 5151-06, | |||
| following ASTM D6319- | |||
| 10, G-1, AQL 2.5 | In accordance with | ||
| ASTM 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 Skin | |||
| Irritation Study | Under the conditions of | ||
| the study, | |||
| not an irritant | Under the conditions of | ||
| the study, | |||
| not an irritant | Same | ||
| 10993-10:2010 | |||
| Maximization | |||
| Sensitization Study | Under the conditions of | ||
| the study, | |||
| not a sensitizer | Under the conditions of | ||
| the study, | |||
| not a sensitizer | Same | ||
| 10993-5:2009 | |||
| Cytotoxicity Test | Under the conditions of | ||
| this study, not a cytotoxic | |||
| potential | Under the conditions of | ||
| this study, not a cytotoxic | |||
| potential | Same |
Chemotherapy Permeation Comparison:
| Minimum BDT (Minutes) | Comparison | ||
|---|---|---|---|
| Tested Chemotherapy Drug | |||
| and Concentration | Proposed | ||
| Device | |||
| K182600 | Predicate | ||
| Device | |||
| K173942 | |||
| Carmustine(BCNU) (3.3 | |||
| mg/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 |
9
510(K) SUMMARY
10
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.