(443 days)
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.
The document describes the acceptance criteria and performance data for the "Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate". This is a medical device, and the evaluation focuses on its physical properties, chemical permeation resistance, and biocompatibility.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Standard | Acceptance Criteria | Reported Device Performance | Outcome |
|---|---|---|---|---|
| Physical Properties | ||||
| Length (Physical Dimension) | ASTM D6319-10 | Min 240mm | Min 240mm | Passed |
| Thickness Palm & Finger (Physical Dimension) | ASTM D6319-10 | Min 0.05mm | Min 0.05mm | Passed |
| Width by sizes (XS, S, M, L, XL) (Physical Dimension) | ASTM D6319-10 | XS - 70mm, S - 80mm, M - 95mm, L - 110mm, XL - 120mm (Tolerance: ± 10mm) | XS - 70mm, S - 80mm, M - 95mm, L - 110mm, XL - 120mm (Tolerance: ± 10mm) | Passed |
| Tensile Strength Before Aged (Physical Properties) | ASTM D6319-10 | Min: 14MPa | Min: 14MPa | Passed |
| Tensile Strength After Aged (Physical Properties) | ASTM D6319-10 | Min: 14MPa | Min: 14MPa | Passed |
| Ultimate Elongation Before Aged (Physical Properties) | ASTM D6319-10 | Min 500% | Min 500% | Passed |
| Ultimate Elongation After Aged (Physical Properties) | ASTM D6319-10 | Min 400% | Min 400% | Passed |
| Powder Content (Powder Residual) | ASTM D6124-06(2017) | Powder Amount: < 2mg | Powder Amount: < 2mg | Passed |
| Freedom from Holes (Watertight @1000ml) | ASTM D5151-19 | AQL 2.5 | AQL 2.5 | Passed |
| Biocompatibility | ||||
| Irritation and delayed-type hypersensitivity | ISO 10993-10:2010 | No Skin sensitization and irritation | No skin sensitization and irritation | Passed |
| Cytotoxicity | ISO 10993-5:2009 | No Cytotoxicity Reaction | Exhibits severe cytotoxicity reactivity at 100%, 66% extract concentrations. No cytotoxicity at 44%, 30%, 20%, 15% extract concentrations. (Subject device: undiluted, 1:2 and 1:4 dilution is cytotoxicity and the dilution 1:8 and 1:16 and 1:32 is non-cytotoxic.) | Failed (based on acceptance criteria interpreted as "no cytotoxicity reaction" at any concentration) - Note: The document states "Cytotoxicity reaction, Failed" for the subject device. |
| Acute Systemic toxicity | ISO 10993-11:2017 | No adverse biological reaction | No adverse biological reaction | Passed |
| Chemical Permeation (Chemotherapy Drugs) | ASTM D6978 | Minimum Breakthrough Detection Time (minutes) indicated for each drug | Reported Breakthrough Detection Time (minutes) for each drug | |
| Cisplatin (1.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Dacarbazine (10.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Doxorubicin HCI (2.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Etoposide (20.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Fluorouracil (50.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Ifosfamide (50.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Methotrexate (25.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Mitomycin C (0.5 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Mitoxantrone (2.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Paclitaxel (6.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Carmustine (BCNU) (3.3 mg/ml) | > 240 (implied target for general safe use, but specific low time is reported) | 24.3 | Not Met (explicitly warned against use) | |
| ThioTepa (10.0 mg/ml) | > 240 (implied target for general safe use, but specific low time is reported) | 48.6 | Not Met (explicitly warned against use) | |
| Fentanyl Citrate Injection (100.0 mcg/2ml) | ASTM D6978 | > 240 | > 240 | Met Target/Passed |
Note on Cytotoxicity: The document states the cytotoxicity test "Failed" for the subject device based on the acceptance criteria of "No Cytotoxicity Reaction," as it exhibited severe cytotoxicity at higher concentrations (100% and 66% extract concentrations). However, it notes no cytotoxicity at lower concentrations (44%, 30%, 20%, 15%). The comparison table states "undiluted, 1:2 and 1:4 dilution is cytotoxicity and the dilution 1:8 and 1:16 and 1:32 us non-cytotoxic," and then concludes "Same" when comparing to the predicate device's cytotoxicity results. This implies that this level of cytotoxicity at higher concentrations is considered acceptable within the context of substantial equivalence, despite failing a generic "No Cytotoxicity Reaction" criteria. The device is still cleared, usually meaning the risk is mitigated or assessed as acceptable for the intended use.
Note on Carmustine and ThioTepa: For Carmustine and ThioTepa, the breakthrough times are explicitly stated as "extremely low" and the warning "Do not use with Carmustine and ThioTepa" is included in the Indications for Use and the summary. This indicates these permeation times are not meeting the general acceptance criteria of > 240 minutes for safe use with chemotherapy drugs, and the device is therefore not indicated for use with these specific drugs.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of gloves, batches) used for each individual test. It lists the standards followed (e.g., ASTM D6319-10, ASTM D6124-06(2017), ASTM D5151-19, ISO 10993, ASTM D6978-2005). These standards typically define sampling plans, but the specific number of units tested is not reported in this summary.
The data provenance is from non-clinical tests conducted by the manufacturer, Professional Latex Sdn Bhd, located in Malaysia. The tests are reported as demonstrating that the proposed device met all design specifications according to the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For medical device performance testing as described (physical, chemical, biocompatibility), "ground truth" is established by the specified test methods in the standards (e.g., ASTM for physical properties and chemical permeation, ISO for biocompatibility). These tests usually involve laboratory analysis and measurements rather than expert consensus on interpretation of, for instance, medical images. The results are objective measurements against predefined criteria.
4. Adjudication method for the test set
This is not applicable as the tests are primarily objective measurements against established standard criteria, not subjective interpretations requiring adjudication by experts.
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 document pertains to the safety and performance testing of a physical medical device (examination gloves), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document is not about an algorithm or AI.
7. The type of ground truth used
The "ground truth" for the acceptance criteria is based on:
- Standardized Test Methods and Specifications: For physical properties (e.g., length, thickness, tensile strength, elongation, powder content, freedom from holes), the ground truth is defined by the requirements of international and national standards such as ASTM D6319-10, ASTM D6124-06(2017), and ASTM D5151-19.
- Permeation Resistance Measurement: For chemotherapy drugs and fentanyl citrate, the ground truth is the measured breakthrough detection time according to ASTM D6978-2005.
- Biocompatibility Standards: For irritation, sensitization, cytotoxicity, and acute systemic toxicity, the ground truth is determined by the Pass/Fail criteria defined within ISO 10993 standards (ISO 10993-10, ISO 10993-5, ISO 10993-11).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for physical product validation.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
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March 30, 2023
Professional Latex Sdn Bhd Kok Yoon Lim Managing Director Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1 Kawasan Perusahaan Kamunting Raya, Kamunting, Perak Darul Ridzuan 34600 Malaysia
Re: K220088
Trade/Device Name: Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: January 5, 2023 Received: March 2, 2023
Dear Kok Lim:
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) K220088
Device Name
Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy Drugs and | Minimum |
|---|---|
| Concentration: Cisplatin, 1.0 mg/ml | > 240 |
| Cyciophosphamide (Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine, 10.0 mg/ml | > 240 |
| Doxorubicin HCI, 2.0 mg/ml | > 240 |
| Etoposide, 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Paclitaxel, 6.0 mg/ml | > 240 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Carmustine (BCNU), 3.3 mg/ml | 24.3 |
| ThioTepa, 10.0 mg/ml | 48.6 |
Fentanyl Citrate Injection 100.0 mcg/2ml
Breakthrough Detection Time (minutes)
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WARNING.
Please note that the following drugs have extremely low permeation time:
Carmustine (BCNU), 3.3 mg/ml : 24.3 minutes and Thiotepa, 10.0 mg/ml : 48.6 minutes Do not use with Carmustine 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 K220088
| 1.0 | Submitter |
|---|---|
| Professional Latex Sdn Bhd | |
| Lot Plant 2: Lot 20734 & 20735, Lengkungan | |
| Perusahaan Kamunting 3/1, Kawasan Perusahaan | |
| Kamunting Raya, 34600 Kamunting, Perak Darul | |
| Ridzuan, Malaysia. |
| Tel: | +605 891 6650 |
|---|---|
| Name Of Contact Person: | Foong Kah Kah |
| Email Address: | foongkk@professionallatex.com |
| Date of Summary Prepared: | 25 March, 2023 |
2.0 Name of Device
Trade Name:
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
| 510(K) Number: | K220088 |
|---|---|
| Classification Name: | Polymer Patient Examination GlovePatient Examination Gloves, SpecialtyFentanyl And Other Opioid Protection Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Device Class: | I |
| Product Code: | LZA, LZC, OPJ, QDO |
3.0 Identification of The Legally Marketed Device
Predicate Device Name: Blue Colored, Powder Free Nitrile Patient Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
| Company: | Comfort Rubber Gloves Industries Sdn. Bhd |
|---|---|
| Predicate 510(K) Number: | K192954 |
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4.0 Description of Device
Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.
5.0 Intended Use/Indications for Use of Glove
Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Minimum Breakthrough Detection Time (Minutes)
| Cisplatin, 1.0 mg/ml | > 240 |
|---|---|
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine, 10.0 mg/ml | > 240 |
| Doxorubicin HCI, 2.0 mg/ml | > 240 |
| Etoposide, 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Paclitaxel, 6.0 mg/ml | > 240 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Carmustine (BCNU), 3.3 mg/ml | 24.3 |
| ThioTepa, 10.0 mg/ml | 48.6 |
| Fentanyl Citrate Injection 100.0mcg/2ml | > 240 |
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WARNING.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU), 3.3mg/ml : 24.3 minutes and ThioTepa, 10.0mg/ml : 48.6 minutes.
Do not use with Carmustine and ThioTepa.
Summary of the Technologies Characteristic of the Device compared to the 6.0 Predicate Device
Powdered Free Nitrile Examination Gloves, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are summarized with the following characteristics compared to to ASTM D6139-10 Standard technological Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in table.
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| Characteristics | 510(K) | Device Performance | Comparison Result | ||
|---|---|---|---|---|---|
| Standards | Number | Predicate deviceK192954 | Subject deviceK220088 | ||
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same. | ||
| Product Code | LZA, LZC, QDO | LZA, LZC,QDO,OPJ | Similar | ||
| Material | ASTM-D6319-10 | Synthetic Nitrilerubber | Synthetic Nitrilerubber | Same. | |
| Size | ASTM-D6319-10 | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same. | |
| PhysicalDimension | ASTM-D6319-10 | Length:Min 240mmThickness Palm &finger:Min: 0.05Width by sizes:XS - 70mmS - 80mmM - 95mmL -110mmXL - 120mmTolerance:± 10mm | LengthMin: 240mmThickness Palm& finger:Min: 0.05Width by sizes:XS - 70mmS - 80mmM - 95mm LL - 110mmXL - 120mmTolerance:± 10mm | SimilarMeeting therequirements ofDimensionunder ASTM-D6319-10. | |
| PhysicalProperties | ASTM-D6319-10 | Tensile StrengthBefore Aged:Min: 14MPaAfter Aged:Min: 14MPaUltimateElongation:Before aged:Min 500%After aged:Min 400% | Tensile StrengthBefore Aged:Min: 14MPaAfter Aged:Min: 14MPaUltimateElongation:Before aged:Min 500%After aged:Min 400% | SimilarMeeting therequirements ofphysicalpropertiesunder ASTM-D6319-10. | |
| PowderContent | ASTM-D6124-06(2017) | Powder Amount:$\leq 2mg$ | Powder Amount:$\leq 2mg$ | SimilarMeeting therequirements ofPowder Contentunder ASTM-D6124-06(2017). | |
| Freedom fromHoles(Watertight@1000ml) | 21 CFR 800.20ASTM D5151 | Meets ASTMD6139-10 andASTM D5151-06requirements ofAQL 2.5 | AQL .2,5 | SimilarMeeting thefreedom fromholesrequirementunder ASTM-D5151 | |
| Color | No standardsrequirements | Blue | Blue | SimilarBoth are similarin color | |
| Single Use | Designated assingle use gloves | Single use | Sigle use | Same. Both aresingle usegloves. | |
| Sterility | Designated as non-sterile gloves | No sterility reportas sold as non-sterile | No sterilityreport as sold asnon-sterile | Same. Both arenon-sterilizedGloves |
Table 1: Technological Characteristic Comparison Table
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Table 2: Powder Free Examination Gloves, Non-sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate
| Characteristics | Standard | 510(K) Number | Device Performance | Comparison result | |
|---|---|---|---|---|---|
| ChemotherapyDrugs PermeationTest | ASTMD6978-05 | Predicate device | Subject deviceK220088 | ||
| Chemotherapy Drug | Concentrationmg/ml | Minimum BreakthroughDetection Time (Minutes) | |||
| Cisplatin | 1.0 | ≥ 240 | > 240 | Similar | |
| Cyclophosphamide(Cytoxan) | 20.0 | ≥ 240 | > 240 | The chemotherapydrugs tested have | |
| Dacarbazine | 10.0 | ≥ 240 | > 240 | similar | |
| Doxorubicin HCI | 2.0 | ≥ 240 | > 240 | breakthrough |
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| Fluorouracil | 50.0 | > 240 | > 240 | drug with low permeation time. |
|---|---|---|---|---|
| Ifofamide | 50.0 | - | > 240 | |
| Methotrexate | 25.0 | - | > 240 | |
| Mitomycin C | 0.5 | - | > 240 | |
| Mitoxantrone | 2.0 | - | > 240 | |
| Paclitaxel | 6.0 | ≥ 240 | > 240 | |
| Vincristine Sulfate | 1.0 | - | > 240 | |
| *Carmustine(BCNU) | 3.3 | 18.2 | 24.3 | |
| *ThioTepa | 10.0 | 57.3 | 48.6 | |
| Fentanyl CitrateInjection | *100 mcg/2ml | ≥ 240 | > 240 | |
| Characteristic | 510(K)Number | Device Performance | Comparison result | |
| Predicate deviceK192954 | Subject deviceK220088 | |||
| Warning Statement | Warning:Please note that thefollowing drugs haveextremely lowpermeation timesCarmustine (BCNU):18.2 minutes andThioTepa: 57.3minutes | WARNING.Please note that thefollowing drugs haveextremely lowpermeation timesCarmustine (BCNU, 3.3mg/ml: 24.3 minutes andThioTepa,10.0mg/ml :48.6 minutesDo not use withCarmustine andThioTepa | SimilarThechemotherapydrugs testedhave similarbreakthroughdetection timesand the drugwith lowpermeation time. |
Table 3: Biocompatible Characteristic & Indication for Use Comparison Table
| Characteristics | 510(K)Number | Device Performance | Comparison result | |
|---|---|---|---|---|
| Standards | Predicate device | Subject device | ||
| Biocompatibility | Primary SkinIrritationISO 10993-10:2010 | Passed.Under theconditions of thestudy, the subjectdevice is non-Irritating | Passed.Under theconditions of thestudy, the subjectdevice is non-irritating | Same.Both are tested tobe non-irritant. |
| DermalSensitizationISO 10993- | Passed.Under the conditionof the study, the | Passed.Under the conditionof the study, the | Same.Both are tested tobe non-sensitizer |
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| 10: 2010 | subject device isnon-sensitizer | subject device isnon-sensitizer | subject device isnon-sensitizer |
|---|---|---|---|
| CytotoxicityISO 10993-5:2009 | Exhibits severecytotoxicityreactivity at 100%,and 66% extractconcentrations andno cytotoxicityreactivity at 44%,30%, 20% and 15%extractconcentrationsunder the conditionof this test. | It is concluded that,undiluted, 1:2 and1:4 dilution iscytotoxicity and thedilution 1:8 and 1:16and 1:32 us non-cytotoxic. | Same |
| AcuteSystemictoxicityISO 10993-11: 2017 | Under the conditionof the study, noevidence ofsystemic toxicity | Under the conditionsof the study, thesubject showed noadverse biologicalreaction | Same.Both are tested tobe non-systemictoxicity |
| Characteristics | Device Performance | ||
|---|---|---|---|
| Indicationfor Use | Predicate device | Subject device | Comparisonresult |
| 510(K) Number: K192954 | 510(K) Number: K220088 | ||
| The Blue Colored, Powder FreeNitrile Examination Gloves, Non-sterile, and Tested for Use withChemotherapy Drugs and FentanylCitrate is a specialty medical glovewhich is a disposable deviceintended for medical purpose that isworn on the examiner's hand orfinger to prevent contaminationbetween examiner and patient. Thegloves was tested for use withChemotherapy Drugs and FentanylCitrate as per ASTM D6978-05Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs.Tested chemotherapy drugs are asfollows: | Powder free NitrileExamination Gloves, Non-Sterile and tested for usewith Chemotherapy Drugsand Fentanyl Citrate is apatient medical examgloves which is a disposaldevice intended for medicalpurposes that is worn onthe examiners' hand orfinger to preventcontamination betweenexaminer and patient.The glove was tested foruse with ChemotherapyDrugs and FentanylCitrate as per ASTM-D6978-05 StandardPractice for Assessment ofMedical Gloves to permeationby chemotherapy Drugs | SimilarBothindicationfor use issimilar. |
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| Average Breakthrough Detection Time (minutes) | Tested Chemotherapy Drugs and Concentration |
|---|---|
| Cisplatin 1.0 mg/ml - ≥ 240Cyclophosphamide (Cytoxan) (20.0 mg/ml) - ≥ 240Dacarbazine (DTIC) (10.0mg/ml) - ≥ 240Doxorubicin Hydrochloride (2.0mg/ml) - ≥ 240Etoposide (20.0 mg/ml) - ≥ 240Fluorouracil (50.0 mg/ml) - > 240Paclitaxel (Taxol) (6.0 mg/ml) – > 240Carmustine (BCNU) 3.3mg/ml 18.2Thiotepa (THT) 10.0mg/ml 57.3 | Minimum Breakthrough Detection Times (Minutes)Cisplatin 1.0mg/ml - > 240Cyclophosphamide (Cytoxan) 20.0mg/ml - > 240Dacarbazine 10.0mg/ml - > 240Doxorubicin HCI 2.0mg/ml - > 240Etoposide 20.0mg/m - > 240Fluorouracil 50.0mg/ml -> 240Ifosfamide 50.0mg/ml - > 240Methotrexate 25.0mg/ml - > 240Mitomycin C 0.5mg/ml - > 240.0Mitoxantrone 20.0mg/ml - > 240Paclitaxel - 6.0mg/ml > 240Vincristine Sulfate -> 240Carmustine (BCNU) 3.3mg/ml - 24.3Thiotepa 10.0mg/ml - 48.6Fentanyl Citrate Injection (100mcg/2ml) - > 240 |
| Tested Fentanyl Citrate is as follows:Average Breakthrough Detection Time (minutes)Fentanyl Citrate Injection 100.0 mg/2ml ≥ 240 | |
| Please note that the following drugs have extremely low permeation times:Carmustine (BCNU) 18.2 minutes and Thiotepa: 57.3 minutes | |
| Warning: Do not use with Carmustine | WARNING. Please note that the following drugs have extremely low permeation time:Carmustine (BCNU) 3.3 mg/ml 24.3 minutes and Thiotepa 10.0mg/ml 48.6 minutesDo not use with Carmustine and Thiotepa |
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7.0 Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications.
The test result demonstrated that the proposed device met the performance criteria with the following standards:
| Standard | Purpose | Acceptance Criteria | Result /Conclusion |
|---|---|---|---|
| ASTMD6319-10 | PhysicalDimension | Length:Min 240mm Thickness Palm & finger:Min 0.05mmWidth by sizes: XS - 70mmS - 80mm M - 95mmL - 110mmTolerance:$\pm$ 10mm | Passed |
| ASTMD6319-10 | PhysicalProperties | Tensile Strength BeforeAged: Min: 14MPaAfter Aged:Min: 14MPa UltimateElongation: Before aged:Min 500%After aged: Min 400% | Passed |
| ASTMD6124-06(2017) | PowderResidual | Powder Amount:< 2mg | Passed |
| ASTMD5151-19 | Freedomfrom Holes(Watertight@1000ml) | AQL 2.5 | Passed |
| ISO10993-10:2010 | Irritation anddelayed-typehypersensitivity | No Skin sensitization andirritation | No skinsensitization andirritation, Passed |
| ISO10993-5:2009 | Cytotoxicity | No Cytotoxicity Reaction | Cytotoxicity reaction,Failed |
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| ISO10993-11:2017 | AcuteSystemictoxicity | No adverse biologicalreaction | Passed | ||
|---|---|---|---|---|---|
| ASTMD6978 | ChemicalPermeation | ChemotherapyDrugs | Concentration(mg/ml) | Breakthrough Time InMinutes | Observation |
| Cisplatin | 1.0 | > 240 | Slightswellingand nodegradation | ||
| Cyciophosphamide | 20.0 | > 240 | Slightswellingand nodegradation | ||
| Dacarbazine | 10.0 | > 240 | Slightswellingand nodegradation | ||
| DoxorubicinHCI | 2.0 | > 240 | Slightswellingand nodegradation | ||
| Etoposide | 20.0 | > 240 | Slightswellingand nodegradation | ||
| Fluorouracil | 50.0 | > 240 | Slightswellingand nodegradation | ||
| Ifosfamide | 50.0 | > 240 | Slightswellingand nodegradation | ||
| Methotrexate | 25.0 | > 240 | Slightswellingand nodegradation | ||
| Mitomycin C | 0.5 | > 240 | Slightswellingand nodegradation | ||
| Mitoxantrone | 2.0 | > 240 | Slightswellingand nodegradation | ||
| Paclitaxel | 6.0 | > 240 | Slightswellingand nodegradation | ||
| VincristineSulfate | 1.0 | > 240 | Slightswellingand nodegradation |
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| Carmustine(BCNU) | 3.3 | 24.3(25.3,27.4,24 | Moderateswelling |
|---|---|---|---|
| .3) | and no | ||
| degradation | |||
| ThioTepa | 10.0 | 48.6 (49.2, | Moderate |
| 58.1, 48.6) | swelling | ||
| and no | |||
| degradation | |||
| Fentanyl Citrate | 100mcg/ml | > 240 | Slight |
| swelling | |||
| and no | |||
| degradation | |||
Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- � ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
-
- ASTM D6124-06(2017) Standard Test Method for Residual Powder on Medical Gloves
- & ASTM D6319-10 Standard Test Method for Residual Powder on Medical Gloves
- & ASTM D6978-2005(2019) Standard Practice for Assessment of Resistances of Medical Gloves to Permeation by Chemotherapy Drugs
- & ISO 10993-5 Biological evaluation of medical devices Part 5 Tests for In Vivo Cytotoxicity
-
- ISO 10993-10 Biological evaluation of medical devices Part 1- Tests for irritation and delayed-type hypersensitivity.
8.0 Clinical Performance Data
Not needed.
9.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.
§ 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.