(91 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 qloves are offered in four sizes: extra-small, small, medium, large, and extra-large.
This document describes the premarket notification (510(k)) for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs). The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K190860). The "device" in this context refers to the Nitrile Examination Gloves. The acceptance criteria and the study that proves the device meets them are based on non-clinical (bench) testing, as no clinical testing was performed or required for this device type.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally defined by compliance with specific ASTM and ISO standards, and the reported performance are the test results demonstrating this compliance.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| ISO 10993-10:2010 (Irritation & Sensitization) | Assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation, or skin sensitization. | Skin Sensitization Test: Provided grades less than 1, otherwise sensitization. Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | Skin Sensitization Test: All grades are 0. All animals survived and no abnormal signs were observed. Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| ISO 10993-5:2009 (Cytotoxicity) | Describes test methods to assess the in vitro cytotoxicity of medical devices. | The viability (%) of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viability (%) of 100% test article extract is 86.5%. This means the proposed device has no potential toxicity to L-929 in the MTT method. |
| Physical Performance | |||
| ASTM D6124-06 (Residual Powder) | Determines the amount of residual powder (or filter-retained mass) found on medical gloves. | Powder residue limit of 2.0 mg. | 0.1 mg / glove. |
| ASTM D5151-19 (Holes) | Covers the detection of holes in medical gloves. | Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion $\leq$ 7 gloves for water leakage. | No glove water leakage found. |
| ASTM D6319-19 (Dimensions & Physical Properties) | Covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. | Dimensions: XS: width 70 $\pm$ 10mm, Length $\geq$ 220 mm S: width 80 $\pm$ 10mm, Length $\geq$ 220 mm M: width 95 $\pm$ 10mm, Length $\geq$ 230 mm L: width 110 $\pm$ 10mm, Length $\geq$ 230 mm XL: width 120 $\pm$ 10mm, Length $\geq$ 230 mm Thickness: Finger $\geq$ 0.05 mm, Palm $\geq$ 0.05 mm Physical properties: Before aging: Tensile strength $\geq$ 14MPa, Ultimate Elongation $\geq$ 500% After Accelerated Aging: Tensile strength $\geq$ 14MPa, Ultimate Elongation $\geq$ 400% | Dimensions: XS: width: 75-76 mm, Length 234-243 mm S: width: 86-87 mm, Length 240-248 mm M: width 98-99 mm, Length 246-256 mm L: width 109-111 mm, Length 250-258 mm XL: width 115-118mm, Length 253-255mm Thickness: Finger: 0.091-0.127 mm (range across sizes) Palm: 0.071-0.094 mm (range across sizes) Physical properties: Before aging: Tensile strength 21.6-29.5 MPa, Ultimate Elongation 536% - 571% After Accelerated Aging: Tensile strength 24.1-31.0 MPa, Ultimate Elongation 479% - 519% |
| Chemotherapy Drug Permeation | |||
| ASTM D6978-05 (Reapproved 2019) | Assesses resistance of medical gloves to permeation by chemotherapy drugs. Minimum breakthrough detection times for various chemotherapy drugs. | Carmustine (BCNU) 3.3 mg/ml: > 15.1 Minutes Cisplatin 1.0 mg/ml: > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes Carboplatin 10.0 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 Paclitaxel 6.0 mg/ml: > 240 Minutes Thio Tepa 10.0 mg/ml: > 32.8 Minutes | Carmustine (BCNU) 3.3 mg/ml: 15.1 minutes (individual results: 15.1, 16.4, 16.6) Cisplatin 1.0 mg/ml: > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes Carboplatin 10.0 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 Paclitaxel 6.0 mg/ml: > 240 Minutes Thio Tepa 10.0 mg/ml: 32.8 minutes (individual results: 48.6, 32.8, 46.1) (Note: A warning is included for Carmustine (BCNU) and Thiotepa due to low permeation times.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Freedom from Holes (ASTM D5151-19): 125 gloves.
- Chemotherapy Drug Permeation (ASTM D6978-05): The table provides individual breakthrough detection times for some drugs, indicating multiple samples were tested (e.g., three reported times for Carmustine and Thio Tepa). Specific sample sizes for each drug are not explicitly stated beyond these examples.
- Other tests (Biocompatibility, Physical Properties, Residual Powder): Specific sample sizes are not detailed in the provided text, but testing was conducted "in accordance with" the listed standards, implying standard-appropriate sample sizes were used.
- Data Provenance: This is a 510(k) submission for a medical device (nitrile examination gloves). The testing is non-clinical (bench testing), meaning it was performed in a laboratory setting to assess the physical and chemical properties of the gloves. The country of origin of the data is not explicitly stated for each test, but the submitting company is 5R MED Instruments (CHENGDU) Co., Ltd. located in China. The testing would have been conducted in a controlled lab environment. The studies are prospective tests performed on the manufactured device to ensure it meets the required standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For a device like examination gloves, "ground truth" is established by laboratory measurements against defined standards (e.g., strength, thickness, permeation time), not by expert human interpretation of medical images or clinical outcomes. The tests are objective, quantifiable measurements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (like medical images) and their discrepancies need to be resolved. For non-clinical bench testing, the results are quantitative and directly measured by calibrated equipment and documented procedures.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are used to evaluate the diagnostic performance of medical imaging devices, often comparing human readers with and without AI assistance. This submission is for examination gloves, which do not involve such diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. "Standalone performance" typically refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. Its performance is demonstrated through physical and chemical property testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective, measurable physical properties and chemical resistance, defined by international standards:
- Standard-defined thresholds: For properties like tensile strength, elongation, freedom from holes (AQL), residual powder, dimensions (length, width, thickness), and breakthrough times for chemotherapy drugs.
- Laboratory measurements: Results obtained from standardized test methods (ASTM, ISO).
- Biocompatibility assessments: Based on established criteria for irritation, sensitization, and cytotoxicity from biological assays.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model. There is no "training set" in the context of examination gloves.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it. The ground truth for the device's performance is based on its physical, chemical, and biological properties measured against established standards during non-clinical testing.
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December 1, 2021
5R MED Instruments (CHENGDU) Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai. 200120 China
Re: K212789
Trade/Device Name: Nitrile 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: August 27, 2021 Received: September 1, 2021
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 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
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Indications for Use
510(k) Number K212789
Device Name
Nitrile 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) | 15.1(15.1, 16.4, 16.6) Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Carboplatin | 10.0 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 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 32.8 (48.6, 32.8, 46.1) Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.1 Minutes (min.); Thio Tepa 10.0 mg/ml 32.8 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
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
K212789
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
5R MED Instruments (CHENGDU) Co., Ltd. Name: Address: Building 9, Section 1, No.618 of West Kelin Road, Chengdu Cross-Straits Technology Industry Development Zone, Wenjiang District, Chengdu, Sichuan Province, 611130, China Mr. Pan Yuzhang Contact: Date of Preparation: 2021.08.12
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
Nitrile Examination Gloves (Tested for Use with Chemotherapy Trade name: Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL
3.0 Classification
Production code: LZA, LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Growth (Vietnam) Co., Ltd.
Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free
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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 qloves are offered in four sizes: extra-small, 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 |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1(15.1,16.4,16.6) |
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Cisplatin | 1.0 mg/ml(1,000 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 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 32.8(48.6, 32.8, 46.1) |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.1 Minutes (min.); Thio Tepa 10.0 mg/ml 32.8 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
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| Subject Device | Predicate Device | ||
|---|---|---|---|
| Item | K212789 | (K190860) | Remark |
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended 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. | 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. | 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 and quantity,Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Similar |
Table1-General Comparison
| Table2 Device Dimensions Comparison | |||||||
|---|---|---|---|---|---|---|---|
| PredicateDevice(K190860) | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: |
Table2 Device Dimensions Comparison
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| Finger | 0.05 | min | |||||
|---|---|---|---|---|---|---|---|
| Palm | 0.05 | min | |||||
| Designation | Size | ||||||
| XS | S | M | L | XL | Tolerance | ||
| Subject Device | Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| Width, mm | 70 | 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 device | Predicate device(K190860) | Remark | |
|---|---|---|---|---|
| Colorant | Blue | White, Orange | Different 1 | |
| PhysicalProperties | BeforeAging | TensileStrength14MPa, min | 14MPa, min | Same |
| UltimateElongation500% min | 500% min | Same | ||
| AfterAging | TensileStrength14MPa, min | 14MPa, min | Same | |
| UltimateElongation400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply with ASTMD6319 | Same | ||
| Freedom from Holes | Be free from holes when testedin accordance withASTMD5151 AQL=2.5 | Be free from holeswhen tested inaccordance withASTMD5151 AQL=2.5 | Same | |
| Powder Content | 0.1mg per glove, Meet therequirements of ASTM D6124 | Meet the requirementsof ASTM D6124 | Same | |
| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | Carmustine (BCNU) 3.3mg/ml: 15.1 Minutes (min.) | Carmustine (BCNU)3.3 mg/ml:White:11.8 Minutes;Orange:31.6Minutes | Similar | |
| Cisplatin 1.0 mg/ml: > 240Minutes | Cisplatin 1.0 mg/ml:>240 Minutes | Same | ||
| Cyclophosphamide (Cytoxan)20.0 mg/ml: > 240 Minutes | Cyclophosphamide(Cytoxan)20.0 mg/ml: > 240 | Same |
Table3 Performance Comparison
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| Minutes | |||
|---|---|---|---|
| Carboplatin 10.0 mg/ml: > 240Minutes | Dacarbazine (DTIC)10.0 mg/ml:>240 Minutes | Different 2 | |
| Doxorubicin HCI 2.0 mg/ml: >240 Minutes | DoxorubicinHydrochloride 2.0mg/ml: >240 Minutes | Same | |
| Etoposide 20.0 mg/ml: > 240Minutes | Etoposide (Toposar)20.0mg/ml: >240 Minutes | Same | |
| Fluorouracil 50.0 mg/ml: >240 Minutes | Fluorouracil 50.0mg/ml: >240Minutes | Same | |
| Paclitaxel 6.0 mg/ml: >240Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same | |
| Thio Tepa 10.0 mg/ml: 32.8Minutes (min.) | Thio-Tepa 10.0 mg/ml:White: 16.9 Minutes;Orange: 72.5 Minutes | Similar |
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 | ||||
|---|---|---|---|---|
| Item | Subject device | Predicated device (K190860) | Remark | |
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under the conditions ofthe study, notan irritant | Comply withISO10993-10 | Same |
| Sensitization (ISO10993-10:2010 | Under conditions of |
Table4 Safety Comparison
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| BiologicalEvaluationofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | the study, not asensitizer. | ||
|---|---|---|---|
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluationofMedical Devices -Part 5: Tests For InVitro Cytotoxicity) | Underconditions ofthe study, thedevice extractis not cytotoxic | Underconditions ofthe study, thedevice extractis not cytotoxic | Same |
| TestMethodology /Standard | Purpose | Acceptance Criteria | Results |
| ISO 10993-10:2010BiologicalEvaluation OfMedical Devices- Part 10: TestsFor Irritation AndSkinSensitization. | This part of ISO10993 assessespossible contacthazards fromchemicals releasedfrom medicaldevices,which may produceskin and mucosalirritation, eyeirritation or skinsensitization. | Skin Sensitization Test:providedgrades less than 1,otherwise sensitization.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 | All grades are 0.All animals were survivedand no abnormal signs wereobserved during the study.The primary irritation indexis 0.The response of theproposed device wascategorized as negligibleunder the test condition |
| ISO 10993-5:2009 BiologicalEvaluation OfMedical Devices- Part 5: TestsFor In VitroCytotoxicity | This part of ISO10993 describestest methods toassess the in vitrocytotoxicity ofmedical devices. | The viab.% of the 100%extract of the test articleis the final result, and ifviability is reduced to<70% of the blank, ithas cytotoxic potential. | Viab.% of 100% test articleextract is 86.5%It means the proposeddevice have no potentialtoxicity to L-929 in the MTTmethod |
| ASTM D6124-06(Reapproved2017), StandardTest Method forResidual Powderon MedicalGloves | This standard isdesigned todetermine theamount ofresidualpowder (or filter-retained mass)found | powder residue limit of2.0 mg | 0.1 mg /glove |
| on medical gloves | |||
| ASTM D5151-19Standard TestMethod forDetection ofHoles in MedicalGloves | This test methodcovers thedetection of holesinmedical gloves. | Samples number: 125glovesAQL: 2.5 (ISO 2859)Criterion $\leq$ 7 gloves forwater leakage | no glove water leakagefound |
| ASTM D6319-19StandardSpecification forNitrile | This specificationcovers certainrequirements fornitrile rubber gloves | Sterility: no needFreedom from holes: pl.Refer to table 3 | N.A. |
| ExaminationGloves forMedicalApplication | used in conductingmedicalexaminations anddiagnostic andtherapeuticprocedures. | Dimensions:XS: width 70 $\pm$ 10mmLength $\geq$ 220 mmS: width 80 $\pm$ 10mmLength $\geq$ 220 mmM: width 95 $\pm$ 10mm | Dimensions:XS: width: 75-76 mmLength 234-243 mmThickness:Finger 0.091-0.100 mmPalm 0.071-0.079 mm |
| Length $\geq$ 230 mmL: width 110 $\pm$ 10mmLength $\geq$ 230 mmXL: width 120 $\pm$ 10mmLength $\geq$ 230 mmThickness:Finger $\geq$ 0.05 mm | S: width: 86-87 mmLength 240-248 mmThickness:Finger 0.098-0.114 mmPalm 0.084-0.094mm | ||
| Palm $\geq$ 0.05 mmPhysical properties:Before agingTensile strength $\geq$14MPa | M: width 98-99 mmLength 246-256 mmThickness:Finger 0.106-0.124 mmPalm 0.077-0.093 mm | ||
| Ultimate Elongation $\geq$500%After Accelerated AgingTensile strength $\geq$14MPaUltimate Elongation $\geq$ | L: width 109-111 mmLength 250-258 mmThickness:Finger 0.111-0.127 mmPalm 0.080-0.088 mm | ||
| 400%Powder-free Residue:pl. Refer to table 3 | XL: width 115-118mmLength 253-255mmThickness:Finger 0.112-0.124 mm | ||
| Palm 0.081-0.093 mm | |||
| Physical properties:Before agingTensile strength 21.6-29.5 MPaUltimate Elongation 536% - 571%After Accelerated AgingTensile strength 24.1-31.0 MPaUltimate Elongation 479% - 519% | |||
| Powder-free Residue:pl. Refer to table 3 | |||
| ChemotherapyDrugsTested withMinimumBreakthroughDetection Time | Carmustine (BCNU) 3.3 mg/ml: 15.1 Minutes (min.) | ||
| ASTM D6978 | Cisplatin 1.0 mg/ml: > 240 Minutes | ||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Carboplatin 10.0 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 | |||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||
| Thio Tepa 10.0 mg/ml: 32.8 Minutes (min.) |
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile 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
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, 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 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.
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:
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- 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) ,Standard Practice for -Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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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, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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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.