(93 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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) | 23.7 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | 240 Minutes |
| Dacarbazine (DTIC) | 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 |
| 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) | 45.7 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes
Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa
WARNING: Do not use with Carmustine
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 non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.
Below is a summary of the acceptance criteria and the study conducted for the Disposable Nitrile Examination Glove, as detailed in the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL: ≥230Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: >230 mm for all sizesWidth: XS: 75-80; S: 85-87; M: 95-98; L: 105-107; XL: 115-117Thickness (mm): XS Finger: 0.10 |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks; S: 1/125 leaks; M: 0/125 leaks; L: 2/125 leaks; XL: 2/125 leaks Result: Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS: 0.08 mg; S: 0.12 mg; M: 0.09 mg; L: 0.10 mg; XL: 0.11 mg. Result: Pass |
| ASTM D412 (Physical Properties) | Physical properties (Tensile Strength & Elongation) | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400% | Before Aging: Tensile Strength: XS:18 |
| ASTM D6978 | Chemotherapy Drugs Permeation (Minimum Breakthrough Time) | Specified minimum breakthrough times for each chemotherapy drug (implied from the predicate device's performance, but the standard does not state a universal minimum) | Carmustine (BCNU): 23.7 MinutesCisplatin: > 240 MinutesCyclophosphamide (Cytoxan): > 240 MinutesDacarbazine (DTIC): > 240 MinutesDoxorubicin HCl: > 240 MinutesEtoposide: > 240 MinutesFluorouracil: > 240 MinutesMethotrexate: > 240 MinutesMitomycin C: > 240 MinutesPaclitaxel: > 240 MinutesThio Tepa: 45.7 MinutesVincristine Sulfate: > 240 Minutes |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Result: Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. Result: Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Result: Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides sample sizes for specific tests:
- ASTM D5151 (Watertightness): 125 gloves per size (XS, S, M, L, XL) were tested.
- The specific sample sizes for other tests like physical dimensions (ASTM D6319, ASTM D412), powder content (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993-5, ISO 10993-10) are not explicitly stated in numerical terms (e.g., "n=X"), but are implied to be sufficient to meet the requirements of the respective ASTM and ISO standards.
- Data Provenance: The studies were conducted by the device manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is located in China. The data would be considered prospective as it involves new testing on the subject device to demonstrate its performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this device. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., ASTM and ISO methods) rather than expert clinical judgment or consensus. These are physical and chemical properties measured according to specific protocols.
4. Adjudication Method for the Test Set:
This is not applicable to this device. As mentioned above, the evaluation relies on objective measurements from standardized test methods, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or other complex data, and their performance is compared with and without AI assistance. Examination gloves are a Class I device with performance assessed via bench testing, not human interpretation.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination glove), not an AI algorithm or software. Its performance is evaluated through material and physical property testing, not algorithmic output.
7. Type of Ground Truth Used:
The ground truth used in these studies is based on objective, quantitative measurements obtained through validated and standardized laboratory test methods as defined by:
- ASTM International (formerly American Society for Testing and Materials) standards: ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978.
- ISO (International Organization for Standardization) standards: ISO 10993-5 and ISO 10993-10.
These standards define the methods for measuring physical properties, chemical resistance, and biocompatibility, and the "ground truth" is the result of these measurements compared against the specified acceptance criteria within the standard.
8. Sample Size for the Training Set:
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" of data. The manufacturing process of examination gloves is based on established engineering principles and quality control, rather than machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for this device.
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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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 11, 2022
Inner Mongolia Boming Medical Supplies Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 East Lujiazui Rd.,Pudong Shanghai, 200120 China
Re: K222733
Trade/Device Name: Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: November 14, 2022 Received: November 14, 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 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.
Bifeng Qian -S
Bifeng Qian., M.D., 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) K222733
Device Name
Disposable Nitrile Examination Glove(Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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) | 23.7 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | 240 Minutes |
| Dacarbazine (DTIC) | 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 |
| 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) | 45.7 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes
Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa
WARNING: Do not use with Carmustine 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
K222733
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Inner Mongolia Boming Medical Supplies Co., Ltd. | |
|---|---|---|
| Address: | Room 326, New Industrial Park Management Committee Office,Tumet Right Banner, Baotou City, Inner Mongolia AutonomousRegion, China | |
| Contact: | Guo Hua | |
| Tel: | +86-13485097856 |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Address: | Shanghai Truthful Information Technology Co., Ltd.Room 1801, No.161 East Lu Jiazui Rd., Pudong,Shanghai,200120 China |
| Tel: | +86-21-50313932 |
| Email: | info@truthful.com.cn |
Date submitted: Dec.7,2022
2.0 Device Information
| Trade name: | Disposable Nitrile Examination Glove (Tested for Use withChemotherapy Drugs) |
|---|---|
| Common name: | Patient Examination Gloves |
| Classification name: | Non-powdered patient examination glove |
| Model(s): | XS, S, M, L, XL |
| Production code: | LZA,LZC, OPJ |
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
3.0 Predicate Device Information
| Manufacturer: | Medline Industries, Inc. |
|---|---|
| Device: | Medline Powder-Free Light Blue Nitrile Exam Glove (Tested forUse with Chemotherapy Drugs) |
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510(k) number: K201390
4.0 Indication for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.7 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 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) | 45.7 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes;
Thio Tepa 10.0 mg/ml 45.7 Minutes.
Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa
WARNING: Do not use with Carmustine.
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 non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.
6.0 Technological Characteristic Comparison Table
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| Item | Subject Device(K222733) | Predicated Device(K201390) | Remark |
|---|---|---|---|
| Product Code | LZA,LZC, OPJ | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use /Indication for Use | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves were testedfor use withchemotherapy drugs asper ASTM D6978-05(2019) StandardPractice for Assessmentof Resistance of MedicalGloves to Permeationby Chemotherapy Drugs. | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves were testedfor use with chemotherapydrugs as per ASTMD6978-05(2019) StandardPractice for Assessment ofResistance of MedicalGloves to Permeation byChemotherapy Drugs. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| LabelingInformation | Single-use indication,powder free, device color,device name, glove sizeand quantity, non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults | Single-use indication,powder free, device color,device name, glove sizeand quantity, non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults. | Same |
Table2 Device Dimensions Comparison
| PredicateDevice(K201390) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Length, mm | XS | S | M | L | XL | ||
| Width, mm | NA | 240 | 240 | 240 | 240 | min | |
| NA | 85 | 95 | 105 | 115 | ±10 | ||
| Thickness, mm: |
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| Finger | 0.16 | min | |||||
|---|---|---|---|---|---|---|---|
| Palm | 0.14 | min | |||||
| Subject Device(K222733) | Designation | Size | |||||
| XS | S | M | L | XL | Tolerance | ||
| 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(K222733) | Predicated device(K201390) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | Light Blue | Different | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14Mpa, min | 17Mpa, min | Different |
| 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 | Comply with ASTM D6319 | Same | ||
| Freedom from Holes | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | Be free from holes when tested in accordance withASTMD5151AQL=2.5 | Same | ||
| Powder Content | Meet the requirements ofASTM D6124<2.0mg | Meet therequirements ofASTM D6124 | Same | ||
| Carmustine (BCNU) 3.3mg/ml: 23.7 Minutes | Carmustine (BCNU)3.3 mg/ml:25.3 Minutes | Different | |||
| Cisplatin 1.0 mg/ml: > 240Minutes | Cisplatin 1.0 mg/ml:≥240Minutes | Same |
Table3 Performance Comparison
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| Cyclophosphamide(Cytoxan) 20.0 mg/ml: > 240 Minutes | Cyclophosphamide(Cytoxan)20.0 mg/ml: ≥240 Minutes | Same | |
|---|---|---|---|
| ChemotherapyDrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | Dacarbazine (DTIC)10.0 mg/ml:≥240 Minutes | Same |
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | DoxorubicinHydrochloride 2.0mg/ml: ≥240 Minutes | Same | |
| Etoposide 20.0 mg/ml: > 240 Minutes | Etoposide (Toposar)20.0mg/ml: ≥240 Minutes | Same | |
| Fluorouracil 50.0 mg/ml: > 240 Minutes | Fluorouracil 50.0mg/ml: ≥240Minutes | Same | |
| Methotrexate 25 mg/ml: > 240 Minutes | Methotrexate 25mg/ml: ≥240Minutes | Same | |
| Mitomycin C 0.5 mg/ml: > 240 Minutes | Mitomycin C 0.5mg/ml: ≥ 240Minutes | Same | |
| Paclitaxel 6.0 mg/ml: >240 Minutes | Paclitaxel (Taxol)6.0 mg/ml:≥240 Minutes | Same | |
| Thio Tepa 10.0 mg/ml: 45.7 Minutes | Thio-Tepa 10.0mg/ml: 43.7Minutes | Different | |
| Vincristine Sulfate 1.0mg/ml: > 240 Minutes | Vincristine Sulfate(Oncovin) 1.0mg/ml: ≥240 Minutes | Same |
Table4 Safety Comparison
| Item | Subject device (K222733) | Predicated device (K201390) | Remark |
|---|---|---|---|
| Material | Nitrile | Nitrile | Same |
| Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests For | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | Same |
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| Irritation And SkinSensitization) | ||||
|---|---|---|---|---|
| Biocompatibility | Sensitization (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | ||
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests For InVitro Cytotoxicity) | Underconditions ofthestudy,device extractisnotcytotoxic | Underconditions ofthestudy,deviceextractiscytotoxic | Different | |
| Acute SystemicToxicity(ISO10993-11:2017,Biologicalevaluation ofmedical devices -Part 11: Tests forsystemic toxicity.) | N/A | Underconditions ofthestudy,deviceextractisnon-toxic | Different |
8.0 Summary of Non-clinical Testing
The biocompatibility evaluation for Disposable Nitrile Medical Examination Glove (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.
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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:
- 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 D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensionsTest | Length(mm): | Length: >230 |
| XS/S:≥220; | Width: | ||
| M/L/XL: ≥230; | XS: 75-80; | ||
| Width(mm): | S: 85-87 | ||
| XS: 70±10; | M: 95-98 | ||
| S: 80±10; | L: 105-107 | ||
| M: 95±10; | XL: 115-117 | ||
| L: 110±10; | |||
| XL: 120±10 | Pass | ||
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | XS:Finger: 0.10 |
Table 5: Summary of Non-clinical Testing Table
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| L:Finger: 0.09 | |||||
|---|---|---|---|---|---|
| ASTM D5151 | WatertightnessTestforDetectionofHoles | Meet the requirements ofASTM D5151 AQL 2.5 | PassXS:0/125 leaksS:1/125 leaksM:0/125 leaksL:2/125 leaksXL:2/125 leaks | ||
| ASTM D6124 | Powder Content | Meet the requirements ofASTM D6124 < 2.0mg | PassXS:0.08 mg;S:0.12mg;M:0.09mg;L:0.10mg;XL:0.11. | ||
| ASTM D412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | PassXS:18 |
| UltimateElongation | ≥500% | PassXS: 520-536S:518 | |||
| AfterAging | TensileStrength | ≥14MPa | PassXS:15 | ||
| L:16 | |||||
| Pass | |||||
| UltimateElongation | ≥400% | XS:500 | |||
| Pass | |||||
| ASTMD6978 | ChemotherapyDrugsTested withMinimumBreakthroughDetection Time | Carmustine (BCNU) 3.3 mg/ml: 23.7 Minutes | |||
| Cisplatin 1.0 mg/ml: > 240 Minutes | |||||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||||
| Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | |||||
| Doxorubicin HCI 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: 45.7 Minutes | |||||
| Vincristine Sulfate 1.0 mg/ml: > 240 Minutes | |||||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions ofthe study, did notshow potentialtoxicity to L-929 cells. | ||
| Pass | |||||
| ISO 10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant. | ||
| Pass | |||||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer. |
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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, Disposable Nitrile Examination Glove (Tested for Use with Chemotherapy Drugs), is as safe, as effective, and performs as well as or better than the legally marketed predicate device under K201390.
§ 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.