(99 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
This document describes the acceptance criteria and the study proving that the "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The device was tested against several standards, as detailed in the "Summary of Non-Clinical Testing" section (pages 8-13). Here's a summary:
| No. | Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization) | Grades less than 1. | All grades were 0. All animals survived with no abnormal signs. The device is not a sensitizer. |
| 2 | ISO 10993-10:2010 (Skin Irritation) | Primary irritation index of 0-0.4 for "Negligible" response. | The primary irritation index was 0. The response was categorized as negligible. The device is not an irritant. |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Viability ≥ 70% of the blank (if viability is reduced to <70%, it has cytotoxic potential). | Viability of 100% test article extract was 21.0%. This indicates potential toxicity to L-929 in the MTT method. (However, refer to Analysis3 in the document stating that systemic toxicity test showed the device is safe despite potential cytotoxicity). |
| 4 | ISO 10993-11:2017 (Systemic Toxicity) | Within 72h, test group toxicosis response not greater than control group. | No evidence of systemic toxicity from the extract. |
| 5 | ASTM D6124-06 (Residual Powder) | Powder residue limit of 2.0 mg per glove. | 0.09-0.11 mg per glove. |
| 6 | ASTM D5151-06 (Freedom from Holes) | Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage. | No glove water leakage found. |
| 7 | ASTM D6319-10 (Physical Properties - Sterility, Dimensions, Tensile Strength, Ultimate Elongation) | Sterility: No need (Non-sterile device) Freedom from holes: Refer to No. 6 Dimensions: Length S: ≥220mm; M, L, XL: ≥230mm. Width S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm. Thickness: Finger ≥0.05mm; Palm ≥0.05mm. Before Aging: Tensile strength ≥ 14MPa; Ultimate Elongation ≥ 500%. After Accelerated Aging: Tensile strength ≥ 14MPa; Ultimate Elongation ≥ 400%. | Sterility: N.A. Freedom from holes: Refer to No. 6. Dimensions: Lot 210515: S: LxW 245-254mm x 82-85mm; M: LxW 249-255mm x 91-94mm; L: LxW 252-260mm x 102-105mm; XL: LxW 250-262mm x 112-115mm. Thickness F: 0.11-0.12mm; P: 0.08mm. Lot 210518: S: LxW 252-255mm x 83-85mm; M: LxW 250-256mm x 91-96mm; L: LxW 254-261mm x 101-106mm; XL: LxW 254-258mm x 111-116mm. Thickness F: 0.11mm; P: 0.08mm. Lot 210520: S: LxW 246-250mm x 82-86mm; M: LxW 245-249mm x 91-95mm; L: LxW 252-259mm x 103-107mm; XL: LxW 254-258mm x 112-116mm. Thickness F: 0.11-0.12mm; P: 0.07-0.08mm. Before Aging: Tensile strength 15.2-24.4 MPa; Ultimate Elongation 525.655% - 798.544%. After Accelerated Aging: Tensile strength 14.0-18.7MPa; Ultimate Elongation 578.552% - 745.388%. |
| 8 | ASTM D6978-05 (Chemotherapy Drug Permeation) | Minimum breakthrough detection times for various chemotherapy drugs (specified in the Indications for Use and Table 4 of the 510(k) summary). | Carmustine (BCNU) 3.3 mg/ml: 23.6 Minutes (min.) Cisplatin 1.0 mg/ml: > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes Dacarbazine 10 mg/ml: > 240 Minutes Doxorubicin HCl 2.0 mg/ml: > 240 Minutes Etoposide 20.0 mg/ml: > 240 Minutes Fluorouracil 50.0 mg/ml: >240 Minutes Methotrexate, 25 mg/ml: >240 Minutes Mitomycin C, 0.5 mg/ml: >240 Minutes Paclitaxel 6.0 mg/ml: >240 Minutes Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.) Vincristine Sulfate, 1mg/ml: >240 Minutes |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides the following details:
- ASTM D5151 (Freedom from Holes): Sample size of 125 gloves. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but is implied to be from laboratory testing conducted as part of the regulatory submission process.
- For other tests (Biocompatibility, Physical Properties, Chemotherapy Drug Permeation), specific sample sizes are not detailed in the provided text. However, testing was stated to be "in accordance with the following standards" (ISO and ASTM), which would implicitly define minimum sample sizes for each test method. Data provenance is implied to be from laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The tests conducted are laboratory-based and follow established international and national standards (ISO, ASTM). The "ground truth" for these tests is defined by the methodologies and performance requirements within these standards, not by expert consensus in a clinical sense.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are laboratory performance tests following well-defined standards, not clinical studies requiring independent adjudication of outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable as the device is a medical glove, and the studies are pre-market non-clinical performance and biocompatibility evaluations. It is not an AI-assisted diagnostic device or a device where human reader performance would be a relevant metric.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is the physical and chemical resistance of the glove itself.
7. Type of Ground Truth Used:
The ground truth for the evaluations is based on:
- Standardized Laboratory Test Results: Defined by the methodologies and acceptance criteria specified in the referenced ASTM and ISO international standards (e.g., specific tensile strength values, breakthrough times, chemical concentrations).
- Biocompatibility Endpoints: As defined by ISO 10993 standards (e.g., absence of irritation, sensitization, systemic toxicity).
8. Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 1, 2022
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K220488
Trade/Device Name: Disposable Nitrile Powder-Free 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: April 25, 2022 Received: May 2, 2022
Dear Boyle Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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,
Bifeng Oian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220488
Device Name
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6 (23.6, 27.5, 25.2) Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 Minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 Minutes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 37.4 (38.8, 37.4, 37.5) Minutes |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes (min.); Thio Tepa 10.0 mg/ml 37.4 Minutes (min.). Warning: Please do not use with Carmustine (BCNU) and Thiotena.
| 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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510(k) Summary
K220488
This summary of 510(k) K220488 is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: ANHUI ZHONG LIAN LATEX GLOVES MANUFACTURING CO., LTD. Address: GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY ANHUI CHINA GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY Contact: ANHUI CHINA Date of Preparation: 2022.05.26
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S. M. L. XL
3.0 Classification
Production code: LZA,LZC Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Ever Growth (Vietnam) Co., Ltd. Manufacturer: Disposable Powder Free Nitrile Examination Glove, Tested For Device:
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Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
510(k) number: K190860
5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
6.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes(minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6(23.6, 27.5, 25.2 ) |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 37.4(38.8, 37.4, 37.5) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes (min.);
Thio Tepa 10.0 mg/ml 37.4 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
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7.0 Technological Characteristic Comparison Table
| Item | Subject DeviceK220488 | Predicate Device(K190860) | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| IntendedUse/Indications forUse | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | A patient examination glovesis a disposable deviceintended for medical purposethat is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 Standard Practicefor Assessment of Medicalgloves toPermeation byChemotherapy Drugs. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove size andquantity,Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults. | Single-use indication,powder free, device color,device name, glove size andquantity, Non-Sterile, astatement of standardASTM D6978-05compliance and a summaryof the testing results. | Similar |
Table1-General Comparison
Table2 Device Dimensions Comparison
| PredicateDevice(K190860) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL |
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| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
|---|---|---|---|---|---|---|---|
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Subject Device | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Different |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions.
| Item | Subject deviceK220488 | Predicate device(K190860) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White, Orange | Different 1 | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | 14MPa, min | Same |
| UltimateElongation | 500% min | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | 14MPa, min | Same | |
| UltimateElongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | |||
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same | ||
| Powder Content | 0.09-0.11 mg per glove, Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same | ||
| Chemotherapy DrugsTested with MinimumBreakthrough | Carmustine (BCNU) 3.3 mg/ml:23.6 Minutes (min.)Cisplatin 1.0 mg/ml: > 240 | Carmustine (BCNU) 3.3 mg/ml:White:11.8 Minutes;Orange:31.6MinutesCisplatin 1.0 mg/ml: > 240 | Similar | ||
| Detection Time asTested per ASTM D6978 | Minutes | 240 Minutes | |||
| Cyclophosphamide (Cytoxan)20.0 mg/ml: > 240 Minutes | Cyclophosphamide(Cytoxan)20.0 mg/ml: > 240Minutes | Same | |||
| Dacarbazine 10 mg/ml:> 240Minutes | Dacarbazine (DTIC)10.0 mg/ml:>240 Minutes | Same | |||
| Doxorubicin HCl 2.0 mg/ml: >240 Minutes | DoxorubicinHydrochloride 2.0mg/ml: >240 Minutes | Similar | |||
| Etoposide 20.0 mg/ml: > 240Minutes | Etoposide (Toposar)20.0mg/ml: >240 Minutes | Similar | |||
| Fluorouracil 50.0 mg/ml: >240 Minutes | Fluorouracil 50.0mg/ml: >240Minutes | Same | |||
| Methotrexate, 25 mg/ml(25,000 ppm): >240 Minutes | / | ||||
| Mitomycin C, 0.5 mg/ml (500ppm): >240 Minutes | / | Different 2 | |||
| Paclitaxel 6.0 mg/ml: >240Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same | |||
| Thio Tepa 10.0 mg/ml: 37.4Minutes (min.) | Thio-Tepa 10.0 mg/ml:White:16.9 Minutes;Orange: 72.5 Minutes | Similar | |||
| Vincristine Sulfate, 1mg/ml(1,000 ppm): >240 Minutes | / | Different 2 |
Table3 Performance Comparison
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Analysis:
Different 1: The color of the subject device is different of that of the predicate. Biocompatibility testing was successfully completed for the subject device,
demonstrating that any color differences do not affect the safety of the proposed device.
Different 2: The chemotherapy drug is different with that of the predicate, but they all meet the requirements of ASTM D6978-05(2019),so the differences do not raise any new safety or performance questions.
Table4 Safety Comparison
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| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis3 | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
biocompatibility evaluation for Disposable Nitrile The Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance 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 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Disposable Nitrile Powder-Free Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 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.
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In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
-
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 Disposable Nitrile -Powder-Free Examination Gloves for Medical Application.
-
-ASTM D 6978-05 (Reapproved 2019) ,Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For IrritationAnd Skin Sensitization. | This part of ISO10993 assessespossible contacthazards fromchemicalsreleased frommedical devices,which mayproduce skin andmucosal irritation,eye irritation orskin sensitization. | Skin Sensitization Test:providedgrades less than 1,otherwisesensitization. | All grades are 0.All animals were survived and noabnormal signs were observedduring the study. |
| 2 | Skin Irritation Test:If the primary irritationindex is 0-0,4, theresponse category isNegligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe | The primary irritation index is 0.The response of the proposeddevice was categorized asnegligible under the testcondition | ||
| 3 | ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describestest methods toassess the in vitrocytotoxicity ofmedical devices. | The viab.% of the100% extract of thetest article is the finalresult, and if viability isreduced to <70% ofthe blank, it hascytotoxic potential. | Viab.% of 100% test articleextract is 21.0%It means the proposed devicehave potential toxicity to L-929 inthe MTT method |
| 7 of | 7 |
|---|---|
| ------ | --- |
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| 4 | ISO 10993-11: 2017Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity | To evaluate thepotential formedical devicematerials to causeadverse systemicreactions. | Within the monitoringperiod (72 h), if thetoxicosis response oftesting group is notgreater than that ofcontrol group, thetesting sample isregarded asacceptable. | There was no evidence ofsystemic toxicity from the extract. | Tensile strength ≥ 14MPaUltimate Elongation ≥ 500%After Accelerated AgingTensile strength ≥ 14MPaUltimate Elongation ≥ 400%Powder-free Residue:pl. Refer to No. 4 in table 5 | Tensile strength 15.2-17.6 MPaUltimate Elongation 629.928% - 788.321%After Accelerated AgingTensile strength 14.2-18.7MPaUltimate Elongation 601.793% - 738.384%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210518Dimensions:S: width: 83-85 mmLength 252-255 mmM: width 91-96 mmLength 250-256 mmL: width 101-106 mmLength 254-261 mmXL: width 111-116 mmLength 254-258 mmThickness:Finger 0.11mmPalm 0.08mmPhysical properties:Before agingTensile strength 17.1-24.4 MPaUltimate Elongation 525.655% - 750.940%After Accelerated AgingTensile strength 14.0-18.1MPaUltimate Elongation 578.552% - 755.773%Powder-free Residue:pl. Refer to No. 4 in table 5Lot no.:210520Dimensions:S: width: 82-86 mmLength 246-250 mm | |
|---|---|---|---|---|---|---|---|
| 5 | ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard isdesigned todetermine theamount ofresidualpowder (orfilter-retainedmass) foundon medical gloves | powder residue limit of2.0 mg | 0.09-0.11 mg /glove | |||
| 6 | ASTMD5151-06(Reapproved2015), Standard TestMethod for Detection ofHoles in Medical Gloves. | This test methodcovers thedetection of holesinmedical gloves. | Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion ≤7 glovesfor water leakage | no glove water leakage found | |||
| 7 | ASTMD6319-10(Reapproved2015),StandardSpecification For NitrileExamination Gloves ForMedical Application. | This specificationcovers certainrequirements fornitrile rubbergloves used inconductingmedicalexaminations anddiagnostic andtherapeuticprocedures. | Sterility: no needFreedom from holes:pl. Refer to No. 5 intable 5Dimensions:S: width 80±10mmLength ≥220 mmM: width 95±10mmLength ≥230 mmL: width 110±10mmLength ≥230 mmXL: width 120±10mmLength ≥230 mmThickness:Finger ≥0.05 mmPalm ≥0.05 mmPhysical properties: | N.A.Please refer to No. 5 in table 5Lot no.:210515Dimensions:S: width: 82-85 mmLength 245-254 mmM: width 91-94 mmLength 249-255 mmL: width 102-105 mmLength 252-260 mmXL: width 112-115 mmLength 250-262 mmThickness:Finger 0.11-0.12 mmPalm 0.08 mmPhysical properties: |
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| Length 245-249 mmL: width 103-107 mmLength 252-259 mmXL: width 112-116 mmLength 254-258 mmThickness:Finger 0.11-0.12 mmPalm 0.07-0.08 mm | ||||
|---|---|---|---|---|
| Physical properties:Before agingTensile strength 16.1-19.8 MPaUltimate Elongation 668.374% -798.544%After Accelerated AgingTensile strength 14.5-18.4MPaUltimate Elongation 621.273% -745.388%Powder-free Residue:pl. Refer to No. 4 in table 5 | ||||
| 8 | ASTM D6978 | ChemotherapyDrugsTested withMinimumBreakthroughDetection Time | Carmustine (BCNU) 3.3 mg/ml: 23.6 Minutes (min.) | |
| Cisplatin 1.0 mg/ml: > 240 Minutes | ||||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240Minutes | ||||
| Dacarbazine 10 mg/ml :> 240 Minutes | ||||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | ||||
| Etoposide 20.0 mg/ml: > 240 Minutes |
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| Fluorouracil 50.0 mg/ml: >240 Minutes | ||
|---|---|---|
| Methotrexate, 25 mg/ml (25,000 ppm): >240 Minutes | ||
| Mitomycin C, 0.5 mg/ml (500 ppm): >240 Minutes | ||
| Paclitaxel 6.0 mg/ml: >240 Minutes | ||
| Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.) | ||
| Vincristine Sulfate, 1mg/ml (1,000 ppm): >240 Minutes |
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.
§ 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.