(155 days)
Not Found
No
The device is a physical product (examination gloves) and the description focuses on material properties and performance against standards, with no mention of AI/ML.
No
The device, "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs," is intended to prevent contamination between patient and examiner. It is a protective barrier, not a device used to treat or cure a disease or condition.
No.
Explanation: The device is a glove, intended for protection and prevention of contamination during medical examinations, not for diagnosing medical conditions.
No
The device is a physical product (gloves) and not software. The description details material properties, physical dimensions, and resistance to chemicals, which are characteristics of a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of these gloves is to prevent contamination between a patient and an examiner by being worn on the examiner's hand. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on physical properties, material (nitrile), and resistance to chemotherapy drugs. These are characteristics of a protective barrier, not a diagnostic tool.
- Performance Studies and Key Metrics: The performance studies and key metrics listed relate to the physical integrity, biocompatibility, and chemical resistance of the gloves (e.g., tensile strength, elongation, freedom from holes, breakthrough time for chemotherapy drugs). These are not diagnostic performance metrics like sensitivity, specificity, or AUC.
The device is a medical device, specifically a Class I Patient Examination Glove and Specialty Chemotherapy Glove, but its function is protective and preventative, not diagnostic.
N/A
Intended Use / Indications for Use
Powder Free Nittile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for ● systemic toxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves ● to Permeation by Chemotherapy Drugs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum BDT (Breakthrough Detection Time) for chemotherapy drugs.
Length: Minimum 230mm, all size ≥230
Palm Width: XS: 77-78mm, S: 86-88mm, M: 96-98mm, L: 108-110mm, XL: 116-117mm
Thickness: Finger: ≥0.05mm, Palm: ≥0.05mm
Tensile Strength, Before Aging: ≥14 MPa
Tensile Strength, After Accelerated Aging: ≥14 MPa
Ultimate Elongation, Before Aging: ≥500%
Ultimate Elongation, After Accelerated Aging: ≥400%
Freedom from holes: Meet and above AQL2.5 requirements
Powder-Content: ≤2 mg, meet requirements
Skin Irritation Study: Under the conditions of the study, not an irritant
Maximization Sensitization Study: Under the conditions of the study, not a sensitizer
Cytotoxicity Test: Under the conditions of this study, the test article extract showed potential toxicity
Systemic toxicity: Under the conditions of this study, there was no evidence of systemic toxicity.
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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2021
Shanxi Hongjin Plastic Technology Co., Ltd. Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K211604
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: July 23, 2021 Received: September 22, 2021
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.
1
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 (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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical And Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211604
Device Name
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Powder Free Nittile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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:
| * Please note that the following drugs have extremely low permeation times: | |||
|---|---|---|---|
| Click Class of Children Carder Carder Carder | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
| Chemotherapy Drug | Minimum BDT (Minutes |
|---|---|
| Bleomycin (15.0mg/ml) | >240 |
| Bortezomib (Velcade) 1mg/ml | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Carmustine(BCNU) (3.3 mg/ml) | 7.0 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Dacarbazine (10mg/ml) | >240 |
| Daunorubicin, HCL (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Doxorubicin HCL (2mg/ml) | >240 |
| Epirubicin HCL (Ellence), (2.0mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Gemcitabine (38.0mg/ml) | >240 |
| Idarubicin HCL (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 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (5.0mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Thio Tepa (10mg/ml) | 23.0 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
3
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 7.0 minutes, Thio Tepa: 23 minutes, Warning: Do not use with Carmustine (BCNU) and Thio Tepa.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
The assigned 510(K) numbers: K211604 Date Prepared: October 27, 2021
1. Owner's Identification:
Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Ou'e Town, Daning County, Linfen City, Shanxi Province
Tel: 86-311-66766067 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@126.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Common Name: Examination Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA LZC Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Better Care Plastic Technology Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (K182600)
4. Device Description:
Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
5
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
5. Indications for Use:
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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(2019) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Bleomycin (15.0mg/ml) | >240 |
| Bortezomib (Velcade) 1mg/ml | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Carmustine(BCNU) (3.3 mg/ml) | 7.0 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Dacarbazine (10mg/ml) | >240 |
| Daunorubicin, HCL (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Doxorubicin HCL (2mg/ml) | >240 |
| Epirubicin HCL (Ellence), (2.0mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Gemcitabine (38.0mg/ml) | >240 |
| Idarubicin HCL (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 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (5.0mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
The following chemicals have been tested with these gloves:
6
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
| Thio Tepa (10mg/ml) | 23.0 |
|---|---|
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 7.0 minutes, Thio Tepa: 23 minutes
6. Comparison of Subject Device and Predicate Device:
The proposed device will be known as Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.
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 K211604 | Predicate Device K182600 | Remark | |
|---|---|---|---|
| Trade Name | Powder Free Nitrile | ||
| Examination Gloves | |||
| (Blue), Tested for Use | |||
| with Chemotherapy | |||
| Drugs | Powder Free Nitrile | ||
| Examination Gloves, | |||
| Tested for Use with | |||
| Chemotherapy Drugs | |||
| (Blue) | Same | ||
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free Nitrile | ||
| Examination Gloves (Blue), | |||
| Tested for Use with | |||
| Chemotherapy Drugs is a | |||
| disposable device intended for | |||
| medical purposes that is worn | |||
| on the examiner's hand to | |||
| prevent contamination | |||
| between patient and examiner. | 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. | Same | ||
| Powder or Powder | |||
| Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Similar |
| Labeling | |||
| Information | Single-use, powder free | ||
| glove size, quantity, | |||
| Nitrile Examination | |||
| Gloves, Non Sterile | Single-use, powder free glove | ||
| size, quantity, Nitrile | |||
| Examination Gloves, Non | |||
| Sterile | Same | ||
| 510(K) SUMMARY | |||
| Chemotherapy Drug | See below comparison | ||
| Permeation Claim | table | See below comparison table | Same |
| Dimensions and Performance Comparison Table: | |||
| Technological | Proposed Device | Predicate Device | |
| Characteristics | K211604 | K182600 | Remark |
| Length | Minimum 230mm | Minimum 230mm | 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 |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| 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 | 400%, min | 400%, min | Same |
| Aging | |||
| In accordance with ASTM D | In accordance with ASTM D | ||
| Freedom from holes | 5151-19, following ASTM | 5151-19, following ASTM | Same |
| D6319- 19, G-I, AQL 2.5 | D6319- 19, G-I, AQL 2.5 | ||
| Powder-Content | 240 | >240 | Same |
| Bortezomib (Velcade) 1mg/ml | >240 | >240 | Same |
| Busulfan (6.0mg/ml) | >240 | >240 | Same |
| Carboplatin, (10.0mg/ml) | >240 | >240 | Same |
| Carmustine(BCNU) (3.3 mg/ml) | 7.0 | 11.0 | similar |
| Chloroquine, (50.0mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (Cytoxan) (20mg/ml) | >240 | >240 | Same |
| Cyclosporin, (100.0mg/ml) | >240 | >240 | Same |
| Cytarabine, (100.0mg/ml) | >240 | >240 | Same |
| Dacarbazine (10mg/ml) | >240 | >240 | Same |
| Daunorubicin, HCL (5.0mg/ml) | >240 | >240 | Same |
| Docetaxel, (10.0mg/ml) | >240 | >240 | Same |
| Doxorubicin HCL (2mg/ml) | >240 | >240 | Same |
| Epirubicin HCL (Ellence), (2.0mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fludarabine, (25.0mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Gemcitabine (38.0mg/ml) | >240 | >240 | Same |
| Idarubicin HCL (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 |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Mitomycin C, (0.5mg/ml) | >240 | >240 | Same |
| Mitoxantrone, (2.0mg/ml) | >240 | >240 | Same |
| Oxaliplatin, (5.0mg/ml) | >240 | >240 | Same |
| Paclitaxel (Taxol) (6mg/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 |
| Thio Tepa (10mg/ml) | 23.0 | 28.8 | similar |
| Topotecan HCL, (1.0mg/ml) | >240 | >240 | Same |
| Trisonex, (1.0mg/ml) | >240 | >240 | Same |
| Vincristine, (1.0mg/ml) | >240 | >240 | Same |
General Comparison Table:
7
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County,
Chemotherapy Permeation Comparison Claim:
8
Coal Bed Gas Ino Industrial Zone, Qu'e Town, Daning County,
510(K) SUMMARY
9
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY 7. 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 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
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for ● systemic toxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves ● to Permeation by Chemotherapy Drugs.
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Length | Minimum 230mm | All size ≥230 |
| ASTM D6319- 19 | Palm Width | XS: 70 $\pm$ 10mm | 77-78mm |
| S: 80 $\pm$ 10mm | 86-88 mm | ||
| M:95 $\pm$ 10mm | 96 -98mm | ||
| L:110 $\pm$ 10mm | 108-110 mm | ||
| XL: 120 $\pm$ 10mm | 116-117 mm | ||
| ASTM D6319- 19 | Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | ≥0.05mm | ||
| ASTM D6319-19 | |||
| ASTN D412-16 | Tensile Strength, Before | ||
| Aging | 14MPa, min | ≥14 MPa | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Tensile Strength, After | ||
| Accelerated Aging | 14MPa, min | ≥14 MPa | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Ultimate Elongation, | ||
| Before Aging | 500%, min | ≥500% | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Ultimate Elongation, | ||
| After Accelerated Aging | 400%, min | ≥400% | |
| ASTM D 5151-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 |
| requirements | |||
| ASTM D 6124-06(2017) | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements |
10
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
|---|---|---|---|
| ISO 10993-10:2010 | Maximization | ||
| Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use with | ||
| Chemotherapy Drugs | / | Details refer to the above 5.0 result |
510(K) SUMMARY
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.