(134 days)
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).
This document is a 510(k) Premarket Notification for Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs). As such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on the performance of an AI/ML powered medical device. Therefore, a significant portion of the requested information (points 2-5, 7-9) about the study design for an AI/ML powered device is not applicable to this document.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The device meets acceptance criteria across several tests, primarily based on ASTM standards.
| Test Standard Followed | Test Conducted | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions - Length (mm) | ≥220 | Pass | Pass |
| ASTM D6319-19 | Physical Dimensions - Width (mm) | S: 80±10, M: 95±10, L: 110±10, XL: 120±10 | Pass | Pass |
| ASTM D6319-19 | Physical Dimensions - Thickness (Finger & Palm) | ≥0.05 mm | Pass | Pass |
| ASTM D6319-19 | Physical Properties - Before Aging | Tensile ≥14Mpa; Elongation ≥500% | Pass | Pass |
| ASTM D6319-19 | Physical Properties - After Aging | Tensile ≥14Mpa; Elongation ≥400% | Pass | Pass |
| ASTM D6319-19 & ASTM D5151-19 | Watertightness Test for detection of holes | Batch size=35000, sample 125, ≤7 defective gloves (AQL 1.5) | Pass | Pass |
| ASTM D6319-19 & ASTM D6124-06 (2017) | Powder Residual | ≤2 (mg/glove) | Pass | Pass |
| ASTM D6978-05(2019) | Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time | Specific breakthrough times for various chemotherapy drugs, generally >240 min, except for Carmustine (BCNU) where a specific time is given, and a "Do Not Use" warning is issued. The acceptance criterion is implicit: the glove must perform as reported for safe use or be explicitly contraindicated for certain drugs based on the test results. | As reported in the table above and below (see section 9. Conclusion) | Pass for indicated drugs |
| ISO 10993-10 | Biocompatibility - Skin Irritation Test | non-irritation | Pass (non-irritation) | Pass |
| ISO 10993-10 | Biocompatibility - Skin Sensitization | non-sensitization | Pass (non-sensitization) | Pass |
| ISO 10993-11 | Biocompatibility - Acute Systemic Toxicity | non-acute systemic toxicity | Pass (non-acute systemic toxicity) | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For the Watertightness Test (detection of holes), the sample size was 125 gloves for a batch size of 35,000.
- For other physical and chemotherapy permeation tests, the specific sample sizes are not explicitly stated within the provided text, but they were conducted "per ASTM D6319-19" and "per ASTM D6978-05(2019)", implying adherence to the sample size requirements of those standards.
- Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the independent labs performing the tests are located) or whether the studies were retrospective or prospective, though performance testing is inherently prospective for a new device. The submitter is XINGYU MEDICAL TECH CO.,LTD. from China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. This document describes performance testing of medical gloves against established ASTM and ISO standards for physical properties, chemotherapy permeation, and biocompatibility. Ground truth in this context is determined by laboratory measurements and chemical/biological assays, not by expert interpretation of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As mentioned above, the assessment criteria are based on objective, standardized laboratory tests, not subjective expert judgment that would require an adjudication method.
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 document is for medical gloves, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document is for medical gloves, not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and observations derived from standardized laboratory tests:
- Physical Measurements: Length, width, and thickness measured according to ASTM D6319-19.
- Mechanical Property Tests: Tensile strength and elongation measured before and after aging according to ASTM D6319-19.
- Watertightness Test: Detection of holes by visual inspection after inflation or water fill, according to ASTM D5151-19.
- Chemical Analysis: Residual powder measured according to ASTM D6124-06 (2017).
- Permeation Testing: Breakthrough time of chemotherapy drugs measured using a sensitive analytical method (e.g., gas chromatography, liquid chromatography) to detect the permeation of the drug through the glove material (as per ASTM D6978-05(2019)).
- Biocompatibility Assays: In-vitro or in-vivo tests to assess skin irritation (e.g., patch tests on animals or human volunteers), dermal sensitization (e.g., guinea pig maximization test), and acute systemic toxicity (e.g., intravenous or oral administration to animals), according to ISO 10993-10 and ISO 10993-11.
8. The sample size for the training set
This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set" or ground truth establishment for such a set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
January 11, 2022
Xingyu Medical Tech Co., Ltd. % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 China
Re: K212735
Trade/Device Name: Nitrile disposable examination gloves (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: December 16, 2021 Received: December 16, 2021
Dear Eva Li:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 medical devices and radiation-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, Ph.D. 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
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Indications for Use
510(k) Number (if known) K212735
Device Name
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough time |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9(68.2,47.9,69.3) |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml (20,000ppm) | >240 min |
| Doxorubicin HCI | 2.0 mg/ml (2,000ppm) | >240 min |
| Etoposide | 20.0 mg/ml (20,000ppm) | >240 min |
| Fluorouracil | 50.0 mg/ml (50,000ppm) | >240 min |
| Paclitaxel | 6.0 mg/ml (6,000ppm) | >240 min |
| ThioTepa | 10.0 mg/ml (10,000ppm) | >240 min |
| Bleomycin Sulfate(Blenoxane) | 15mg/ml (15,000ppm) | >240 min |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 min |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 min |
| Cytarabine | 100mg/ml(100,000ppm) | >240 min |
| Dacarbazine | 10.0mg/ml (10,000ppm) | >240 min |
| Idarubicin HCL | 1mg/ml (1,000ppm) | >240 min |
| Ifosfamide | 50mg/ml (50,000ppm) | >240 min |
| Mechlorethamine HCL | 1mg/ml (1,000ppm) | >240 min |
| MESNA | 100mg/ml (100,000ppm) | >240 min |
| Methotrexate | 25mg/ml (25,000ppm) | >240 min |
| Mitomycin C | 0.5 mg/ml (500ppm) | >240 min |
| Mitoxantrone | 2mg/ml(2,000ppm) | >240 min |
| Trisenox | 1 mg/ml(1,000ppm) | >240 min |
| Vincristine Sulfate | 1 mg/ml (1,000ppm) | >240 min |
| Do Not Use with Carmustine (BCNU). |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
510K Summary
The assigned 510(k) number is: K212735
Premarket Notification [510(k)] Summary
1. Submitter / 510(k) Sponsor:
Submitter's name : XINGYU MEDICAL TECH CO.,LTD. Submitter's Address: NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE, CHINA Phone number: 0086-18263618867 Contact person: Cathrine Luan Email: cathrine@xingyugloves.com
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
Date of Preparation: 2021-12-14
2. Proposed Device
Device Name / Classification Trade Name: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) Common Name: Patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims – Test For Use with Chemotherapy Drugs Product Code: LZA. LZC Classification Panel: General Hospital Regulatory Class: Class I Regulation Number: 21 CFR 880.6250
3. Predicate Device
Device Name: Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with
{5}------------------------------------------------
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
Chemotherapy Drugs) Company Name: Medline Industries, Inc. 510(K) Number: K200960
4. Device Description
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).
5. Indications for Use
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough time |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9(68.2,47.9,69.3) |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml (20,000ppm) | > 240 min |
| Doxorubicin HCI | 2.0 mg/ml (2,000ppm) | > 240 min |
| Etoposide | 20.0 mg/ml (20,000ppm) | > 240 min |
| Fluorouracil | 50.0 mg/ml (50,000ppm) | > 240 min |
| Paclitaxel | 6.0 mg/ml (6,000ppm) | > 240 min |
| ThioTepa | 10.0 mg/ml (10,000ppm) | > 240 min |
| BleomycinSulfate (Blenoxane) | 15mg/ml (15,000ppm) | > 240 min |
| Carboplatin | 10 mg/ml (10,000ppm) | > 240 min |
| Cisplatin | 1.0 mg/ml (1,000ppm) | > 240 min |
| Cytarabine | 100mg/ml(100,000ppm) | > 240 min |
| Dacarbazine | 10.0mg/ml (10,000ppm) | > 240 min |
| Idarubicin HCL | 1mg/ml (1,000ppm) | > 240 min |
| Ifosfamide | 50mg/ml (50,000ppm) | > 240 min |
| Mechlorethamine HCL | 1mg/ml (1,000ppm) | > 240 min |
| MESNA | 100mg/ml (100,000ppm) | > 240 min |
| Methotrexate | 25mg/ml (25,000ppm) | > 240 min |
| Mitomycin C | 0.5 mg/ml (500ppm) | > 240 min |
| Mitoxantrone | 2mg/ml(2,000ppm) | > 240 min |
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XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
K212735(Page 3 / 7)
CHINA
| Trisenox | 1 mg/ml(1,000ppm) | > 240 min |
|---|---|---|
| Vincristine Sulfate | 1 mg/ml (1,000ppm) | > 240 min |
Do Not Use with Carmustine (BCNU).
6. Summary of Technological Characteristics
Table2: Comparison of Proposed and Predicate Devices
| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
|---|---|---|---|
| Product Name | Nitrile disposable examinationgloves (Tested for use withChemotherapy Drugs) | Medline Nitrile Powder FreeDark Blue Examination Gloves(Tested for use withChemotherapy Drugs) | |
| 510(k)Reference | K212735 | K200960 | |
| Product Owner | XINGYU MEDICAL TECH CO.,LTD. | Medline | |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Intended Use | A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloves weretested for use withchemotherapy drugs. | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. Thesegloves were tested for use withchemotherapy drugs. | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| DesignConfigurations | Blue | Dark Blue | Similar |
| Materials | Nitrile | Nitrile | Same |
| Prescription vs.OTC | OTC | OTC | Same |
| ContactDurations | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs.Non-Disposable | Disposable | Disposable | Same |
| Single Use vs.Reusable | Single Use | Single Use | Same |
| Dimensions-Width | Complies with: ASTM D6319-1970mm min | Complies with: ASTM D6319-1070mm min | Same |
| Dimensions- | Complies with: ASTM D6319-19 | Complies with: ASTM D6319-10 | Same |
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K212735(Page 4 / 7)
XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
| Thickness | Palm - 0.05mm min. Finger –0.05mm min | Palm - 0.05mm min. Finger –0.05mm min | |||||
|---|---|---|---|---|---|---|---|
| PhysicalProperties | Complies with: ASTM D6319-19minimum:Tensile Strength:Before Aging ≥14 MPa, min.After Aging ≥14 MPa, min.Elongation: Before Aging 500%, min.After Aging 400%, min. | Complies with: ASTM D6319-10minimum:Tensile Strength:Before Aging ≥14 MPa, min.After Aging ≥14 MPa, min.Elongation: Before Aging 500%, min.After Aging 400%, min. | Same | ||||
| Freedom fromholes | Complies with: ASTM D6319-19and ASTM D5151-19 G-1,AQL 1.5 | Complies with: ASTM D6319-10and ASTM D5151-06 G-1,AQL 1.5 | Same | ||||
| Powder orPowder Free | Powder Free | Powder Free | Same | ||||
| ResidualPowder | Complies with ASTM D6319-19 | Complies with ASTM D6319-10 | Same | ||||
| Biocompatibility | Complies with AAMI/ANSI/ISO10993-10: Not a skin irritant Nota skin sensitizer AAMI/ANSI/ ISO10993-11: Non-Toxic | Complies with AAMI/ANSI/ISO10993-10: Not a skin irritantNot a skin sensitizerAAMI/ANSI/ ISO 10993-11: Non-Toxic | Same | ||||
| ChemotherapyDrugs Testedwith MinimumBreakthroughDetection Timeas tested perASTM D6978 | Chemotherapy Drug | Concentration | Breakthroughtime | ChemotherapyDrug | Concentration | Breakthroughtime | Simliar |
| Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9(68.2,47.9,69.3) | Carmustine(BCNU) | 3.3 mg/ml(3,300 ppm) | 12.4 minutes | ||
| Cyclophosphamide(Cytoxan) | 20.0mg/ml (20,000ppm) | > 240 min | Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 minutes | ||
| Doxorubicin HCl | 2.0 mg/ml (2,000ppm) | > 240 min | Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | >240 minutes | ||
| Etoposide | 20.0 mg/ml(20,000ppm) | > 240 min | Dacarbazine(DTIC) | 10.0 mg/ml(10,000 ppm) | >240 minutes | ||
| Fluorouracil | 50.0 mg/ml(50,000ppm) | > 240 min | DoxorubicinHydrochloride | 2.0 mg/ml(2,000 ppm) | >240 minutes | ||
| Paclitaxel | 6.0 mg/ml (6,000ppm) | > 240 min | Etoposide(Toposar) | 20.0 mg/ml(20,000 ppm) | >240 minutes | ||
| Thio Tepa | 10.0 mg/ml(10,000ppm) | > 240 min | Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 minutes | ||
| BleomycinSulfate(Blenoxane) | 15mg/ml (15,000ppm) | > 240 min | Methotrexate | 25 mg/ml(25,000 ppm) | >240 minutes | ||
| Carboplatin | 10 mg/ml (10,000ppm) | > 240 min | Mitomycin C | 0.5 mg/ml (500ppm) | >240 minutes | ||
| Cisplatin | 1.0 mg/ml(1,000ppm) | > 240 min | Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 minutes | ||
| Cytarabine | 100mg/ml(100,000ppm) | > 240 min | Thio Tepa | 10.0 mg/ml(10,000 ppm) | 27.4 minutes | ||
| Dacarbazine | 10.0mg/ml (10,000ppm) | > 240 min | Vincristine Sulfate(Oncovin) | 1.0 mg/ml(1,000 ppm) | >240 minutes | ||
| Idarubicin HCL | 1mg/ml (1,000ppm) | > 240 min | Do Not Use with Carmustine or Thiotepa | ||||
| Ifosfamide | 50mg/ml (50,00ppm) | > 240 min | |||||
| MechlorethamineHCL | 1mg/ml (1,000ppm) | > 240 min | |||||
| MESNA | 100mg/ml(100,000ppm) | > 240 min | |||||
| Methotrexate | 25mg/ml (25,000ppm) | > 240 min | |||||
| Mitomycin C | 0.5 mg/ml (500ppm) | > 240 min | |||||
| Mitoxantrone | 2mg/ml(2,000ppm) | > 240 min | |||||
| Trisenox | 1 mg/ml(1,000ppm) | > 240 min | |||||
| Vincristine Sulfate | 1 mg/ml (1.000ppm) | > 240 min |
7. Summary of Non-Clinical Testing
Physical performance qualities of the proposed device were evaluated per ASTM D6319- 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation testing was conducted to support the addition of the labeling claim: Tested for use with
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NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE, CHINA
chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs
To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
ASTM D 6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D 6124-06 (2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D 5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D 6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Teststandardfollowed | Testconducted | Acceptance criteria | Conclusion | ||||
|---|---|---|---|---|---|---|---|
| S | M | L | XL | ||||
| ASTM D6319-19 | PhysicalDimensions | Length (mm) | ≥220 | ≥230 | pass | ||
| Width (mm) ±10 | 80±10 | 95±10 | 110±10 | 120±10 | pass | ||
| ThicknessFingerPalm | ≥0.05 mm | pass | |||||
| ASTM D6319-19 | Physicalproperties | Before Aging | Tensile ≥14Mpa; Elongation ≥500% | pass | |||
| After Aging | Tensile ≥14Mpa; Elongation ≥400% | pass | |||||
| ASTM D6319-19Test method inaccordance withASTM D5151-19 | Watertightness Testfor detectionof holes | Batch size=35000, sample 125≤7 | pass | ||||
| ASTM standardD 6319-19Test methodinaccordance withD6124-06(2017) | PowderResidual | ≤2 (mg/glove) | pass | ||||
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K212735(Page 6 / 7)
XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
| ASTM D 6978-05(2019) | ChemotherapyDrugs Testedwith MinimumBreakthroughDetectionTime | Chemotherapy Drug | Concentration | Breakthroughtime |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9(68.2,47.9,69.3) | ||
| Cyclophosphamide(Cytoxan) | 20.0mg/ml (20,000ppm) | > 240 min | ||
| Doxorubicin HCl | 2.0 mg/ml (2,000ppm) | > 240 min | ||
| Etoposide | 20.0 mg/ml(20,000ppm) | > 240 min | ||
| Fluorouracil | 50.0 mg/ml(50,000ppm) | > 240 min | ||
| Paclitaxel | 6.0 mg/ml (6,000ppm) | > 240 min | ||
| ThioTepa | 10.0 mg/ml(10,000ppm) | > 240 min | ||
| BleomycinSulfate(Blenoxane) | 15mg/ml (15,000ppm) | > 240 min | ||
| Carboplatin | 10 mg/ml (10,000ppm) | > 240 min | ||
| Cisplatin | 1.0 mg/ml(1,000ppm) | > 240 min | ||
| Cytarabine | 100mg/ml(100,000ppm) | > 240 min | ||
| Dacarbazine | 10.0mg/ml (10,000ppm) | > 240 min | ||
| Idarubicin HCl | 1mg/ml (1,000ppm) | > 240 min | ||
| Ifosfamide | 50mg/ml (50,00ppm) | > 240 min | ||
| MechlorethamineHCl | 1mg/ml (1,000ppm) | > 240 min | ||
| MESNA | 100mg/ml(100,000ppm) | > 240 min | ||
| Methotrexate | 25mg/ml (25,000ppm) | > 240 min | ||
| Mitomycin C | 0.5 mg/ml (500ppm) | > 240 min | ||
| Mitoxantrone | 2mg/ml( 2,000ppm) | > 240 min | ||
| Trisenox | 1 mg/ml(1,000ppm) | > 240 min | ||
| Vincristine Sulfate | 1 mg/ml (1,000ppm) | > 240 min | ||
| Do Not Use with Carmustine (BCNU). |
8. Biocompatibility
The following tests were performed to evaluate the biocompatibility of the Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
| Test conducted | Standard | Acceptancecriteria | Result |
|---|---|---|---|
| Biocompatibility | Skin Irritation Test ExtractionMethod ISO 10993-10: 2010 | non-irritation | PassesUnder the conditions ofthe study, the subjectdevice is non-irritation |
| Skin sensitization the guineapig maximization ISO 10993-10: 2010 | non- sensitization | PassesUnder the conditions ofthe study, the subjectdevice is non-sensitization | |
| Acute Systemic ToxicityTest ISO 10993-11: 2017 | non- acute systemictoxicity | PassesUnder the conditions ofthe study, the subjectdevice is non-acutesystemic toxicity |
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9. Conclusion
Based on the nonclinical tests data, it can be concluded that the Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as the predicate device, Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) by Medline Industries, Inc. K200960.
§ 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.