(72 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.
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 five sizes: extra-small, small, medium, large, and extra-large.
The provided document is a 510(k) summary for a medical device: "Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)". It details the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on your requested format:
Acceptance Criteria and Device Performance
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: ≥230 | All reported lengths were >230 mm (Pass) | |
| Width (mm) | XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | All reported widths for three lots were within specified ranges (Pass) | |
| Thickness (mm): Finger | ≥0.05 | All reported finger thicknesses for three lots were ≥0.08 mm (Pass) | |
| Thickness (mm): Palm | ≥0.05 | All reported palm thicknesses for three lots were ≥0.08 mm (Pass) | |
| 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: 0/125 leaks; XL: 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.10 mg (Pass) |
| ASTM D412 | Physical properties (Before Aging) | ||
| Tensile Strength | ≥14MPa | Lot 1: 15.4-17.1; Lot 2: 15.6-17.3; Lot 3: 15.7-16.6 (Pass) | |
| Ultimate Elongation | ≥500% | Lot 1: 542-580; Lot 2: 542-570; Lot 3: 545-562 (Pass) | |
| ASTM D412 | Physical properties (After Aging) | ||
| Tensile Strength | ≥14MPa | Lot 1: 15.6-17.0; Lot 2: 15.8-17.0; Lot 3: 15.4-19.2 (Pass) | |
| Ultimate Elongation | ≥400% | Lot 1: 546-577; Lot 2: 547-572; Lot 3: 536-571 (Pass) | |
| ASTM D6978 | Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time | ||
| Carmustine (BCNU) 3.3 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Note: Predicate had 25.3 min, Subject has 22.9 min for this drug as a point of comparison) | 22.9 Minutes (Warning: Do not use with Carmustine) | |
| Cisplatin 1.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Dacarbazine (DTIC) 10.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Doxorubicin HCl 2.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Etoposide 20.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Fluorouracil 50.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Methotrexate 25 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Mitomycin C 0.5 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Paclitaxel 6.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Thio Tepa 10.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Note: Predicate had 43.7 min, Subject has 44.2 min for this drug) | 44.2 Minutes (Caution: Testing showed an average breakthrough time of 44.2 minutes with Thio-Tepa) | |
| Vincristine Sulfate 1.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
2. Sample size used for the test set and the data provenance
- ASTM D6319 (Physical Dimensions, Tensile Strength, Ultimate Elongation): Data is reported for "Lot 1", "Lot 2", and "Lot 3". Each lot appears to represent multiple measurements across different sizes (XS, S, M, L, XL). The exact sample size per lot or per measurement (e.g., how many gloves were measured for length, width, thickness, or subjected to tensile tests) is not explicitly stated, but it follows the standard ASTM D6319 requirements for quality assurance.
- ASTM D5151 (Watertightness): The sample sizes are explicitly stated as 125 gloves per size: XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks, L: 0/125 leaks, XL: 0/125 leaks.
- ASTM D6124 (Powder Content): The sample size for powder content is not explicitly stated.
- ASTM D6978 (Chemotherapy Drug Permeation): The sample size for each drug test is not explicitly stated in the provided text.
- ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization): The sample sizes used for these biocompatibility tests are not explicitly stated, but the tests were conducted "under conditions of the study" which implies adherence to the standard's methodology.
- Data Provenance: All testing appears to be non-clinical (bench testing and laboratory biocompatibility tests). There is no information provided about patient data or country of origin for such data, as this is a device for which clinical testing was not deemed necessary. The testing was conducted in support of a device manufactured by Jiangsu Cureguard Glove Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" in this context is established by standardized physical, chemical, and biological testing methods (ASTM and ISO standards), not by individual expert consensus or interpretation of medical images. The results are objective measurements.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements against predefined acceptance criteria from international standards. There is no element of subjective assessment requiring adjudication in the context of these non-clinical tests.
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
Not applicable. This device is a medical examination glove, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove and does not involve any algorithm or AI component.
7. The type of ground truth used
The ground truth used for performance validation is based on standardized test methods and their defined performance criteria. Specifically:
- ASTM Standards: ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ASTM D6978 (chemotherapy drug permeation). These standards define the procedures for measurement and the expected acceptable ranges or thresholds.
- ISO Standards (Biocompatibility): ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These standards define the methods and parameters for assessing the biological safety of the device.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 5, 2021
Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai. 200120 China
Re: K211608
Trade/Device Name: Disposable Nitrile Medical Examination Glove (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: May 5, 2021 Received: May 25, 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, 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) K211608
Device Name
Nitrile Exam Gloves, Powder Free,Blue (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) | 23.6 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) | 57.4 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 23.6 Minutes Thio-Tepa 10.0 mg/ml 57.4 Minutes
Caution: Testing showed an average breakthrough time of 57.4 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary (K211608)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Cureguard Glove Co., Ltd. Address: No.65 Shenzhen Road, The Economic Development Zone, Sugian , Jiangsu, 223800 China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Aug.5,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Medical Examination Glove(Tested for Use with Chemotherapy 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: Medline Industries, Inc. Medline Powder-Free Light Blue Nitrile Exam Glove (Tested Device: for Use with Chemotherapy Drugs)
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510(k) number: K201390
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 five sizes: extra-small, small, medium, large, and extra-large.
6.0 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) | 22.9 |
| 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) | 44.2 |
| 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 22.9 Minutes; Thio Tepa 10.0 mg/ml 44.2 Minutes.
Caution: Testing showed an average breakthrough time of 44.2 minutes with Thio-Tepa
WARNING: Do not use with Carmustine
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7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K211608) | Predicated Device(K201390) | Remark |
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance 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. | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Table2 Device Dimensions Comparison | |||||||
|---|---|---|---|---|---|---|---|
| Size | |||||||
| Predicate | Designation | XS | S | M | L | XL | Tolerance |
| PredicateDevice(K201390) | Length, mm | NA | 240 | 240 | 240 | 240 | min |
| Width, mm | NA | 85 | 95 | 105 | 115 | ±10 |
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| Thickness, mm: | |||||||
|---|---|---|---|---|---|---|---|
| Finger | 0.16 | min | |||||
| Palm | 0.14 | min | |||||
| Designation | Size | ||||||
| Subject Device(K211608) | Length, mm | XS | S | M | L | XL | Tolerance |
| Width, mm | 220 | 220 | 230 | 230 | 230 | min | |
| 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(K211608) | 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 | Same | |||
| Freedom from Holes | Be free from holes when testedin accordance withASTMD5151 AQL=2.5 | Be free from holes when testedin accordance withASTMD5151 AQL=2.5 | Same | ||
| Powder Content | 0.10 mg per glove, Meet therequirements of ASTM D6124 | Meet the requirementsof ASTM D6124 | Same | ||
| Carmustine (BCNU) 3.3 mg/ml:22.9 Minutes | Carmustine (BCNU)3.3 mg/ml:25.3 Minutes | Different | |||
| Cisplatin 1.0 mg/ml: > 240Minutes | Cisplatin 1.0 mg/ml:$\ge$ 240 Minutes | Same | |||
| Cyclophosphamide (Cytoxan)20.0 mg/ml: > 240 Minutes | Cyclophosphamide(Cytoxan) | Same |
Table3 Performance Comparison
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| Chemotherapy DrugsTested with MinimumBreakthroughDetection Time asTested per ASTM D6978 | 20.0 mg/ml: ≥240Minutes | ||
|---|---|---|---|
| Dacarbazine (DTIC) 10.0mg/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: > 240Minutes | Etoposide (Toposar)20.0mg/ml: ≥240 Minutes | Same | |
| Fluorouracil 50.0 mg/ml: >240Minutes | Fluorouracil 50.0mg/ml: ≥240Minutes | Same | |
| Methotrexate 25 mg/ml: >240Minutes | 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: > 240Minutes | Paclitaxel (Taxol) 6.0mg/ml:≥240 Minutes | Same | |
| Thio Tepa 10.0 mg/ml: 44.2Minutes | Thio-Tepa 10.0 mg/ml:43.7Minutes | Different | |
| Vincristine Sulfate 1.0 mg/ml:> 240 Minutes | Vincristine Sulfate(Oncovin) 1.0mg/ml: ≥240 Minutes | Same |
Table4 Safety Comparison
| Item | Subject device(K211608) | Predicated device(K201390) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization)Sensitization (ISO 10993-10:2010 | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | Same |
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| Biological Evaluation of Medical Devices –Part 10: Tests For Irritation And SkinSensitization) | the study, not a sensitizer. | ||
|---|---|---|---|
| Cytotoxicity (ISO10993-5:2009Biological Evaluation of Medical Devices –Part 5: Tests For In Vitro Cytotoxicity) | Under conditions of the study, device extract is not cytotoxic | Under conditions of the study, device extract is cytotoxic | Different |
| Acute Systemic Toxicity(ISO 10993-11:2017,Biological evaluation of medicaldevices - Part 11: Tests for systemictoxicity.) | N/A | Under conditions of the study, device extract is non-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.
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 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):XS/S:≥220;M/L/XL: ≥230; | Length: >230 |
| Width(mm):XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Width:Lot1:XS: 77-81;S: 85-89M: 97-100L: 108-114XL: 117-120Lot2:XS: 78-80S: 85-90M: 97-100L: 109-114XL: 117-1120Lot3:XS: 77-81S: 85-89M: 97-100L: 109-113XL: 117-121PassLot1:XS:Finger: 0.08-0.10Palm: 0.08-0.10S: | ||
| Finger: 0.07-0.11Palm: 0.08-0.09 | |||
| M:Finger: 0.08-0.10Palm: 0.08-0.10 | |||
| L:Finger: 0.08-0.12Palm: 0.08-0.12 | |||
| XL:Finger: 0.08-0.13Palm: 0.08-0.11 | |||
| Lot2:XS:Finger: 0.08-0.10Palm: 0.08-0.11 | |||
| S:Finger: 0.08-0.10Palm: 0.08-0.12 | |||
| Thickness (mm) :Finger: ≥0.05Palm: ≥0.05 | M:Finger: 0.08-0.12Palm: 0.08-0.11 | ||
| L:Finger: 0.08-0.12Palm: 0.08-0.12 | |||
| XL:Finger: 0.08-0.13Palm: 0.08-0.12 | |||
| Lot3:XS:Finger: 0.08-0.10Palm: 0.08-0.10 | |||
| S:Finger: 0.08-0.11Palm: 0.08-0.10 | |||
| M:Finger: 0.08-0.12Palm: 0.08-0.12 | |||
| L:Finger: 0.08-0.11 |
Table 5 Summary of Non-Clinical Testing
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| Palm: 0.08-0.12XL:Finger: 0.08-0.13Palm: 0.08-0.15Pass | |||||
|---|---|---|---|---|---|
| ASTM D5151 | WatertightnessTestforDetectionofHoles | Meet the requirements of ASTM D5151 AQL 2.5 | XS:0/125 leaksS:1/125 leaksM:0/125 leaksL:0/125 leaksXL:0/125 leaksPass | ||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.10 mg/Pass | ||
| ASTM D412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | Lot 1:15.4-17.1Lot2:15.6-17.3Lot3:15.7-16.6Pass |
| UltimateElongation | ≥500% | Lot1:542-580Lot 2:542-570Lot3:545-562Pass | |||
| AfterAging | TensileStrength | ≥14MPa | Lot 1:15.6-17.0Lot2:15.8-17.0Lot3:15.4-19.2Pass | ||
| UltimateElongation | ≥400% | Lot1:546-577Lot 2:547-572Lot3:536-571Pass | |||
| ASTMD6978 | ChemotherapyDrugsTested withMinimumBreakthroughDetection Time | Carmustine (BCNU) 3.3 mg/ml: 22.9 Minutes | |||
| Cisplatin 1.0 mg/ml: > 240 Minutes | |||||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||||
| Dacarbazine (DTIC) 10.0 mg/ml: > 240 MinutesDoxorubicin HCI 2.0 mg/ml: > 240 MinutesEtoposide 20.0 mg/ml: > 240 MinutesFluorouracil 50.0 mg/ml: > 240 MinutesMethotrexate 25 mg/ml: > 240 MinutesMitomycin C 0.5 mg/ml: > 240 Minutes |
{13}------------------------------------------------
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||
|---|---|---|---|
| Thio Tepa 10.0 mg/ml: 44.2 Minutes | |||
| Vincristine Sulfate 1.0 mg/ml: > 240 Minutes | |||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells.Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant.Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer.Pass |
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 Medical Examination Glove(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 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.