Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Device Facts
| Record ID | K220088 |
|---|---|
| Device Name | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
| Applicant | Professional Latex Sdn Bhd |
| Product Code | LZA · General Hospital |
| Decision Date | Mar 30, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
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.
Device Story
Disposable, non-sterile, ambidextrous nitrile examination glove; light blue color; available in sizes XS-XL. Principle of operation: physical barrier to prevent cross-contamination between examiner and patient. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Used in clinical settings by healthcare professionals or for over-the-counter use. Output: physical barrier protection. Benefit: reduces risk of contamination and exposure to hazardous drugs during medical examinations. Warning: not for use with Carmustine or ThioTepa due to low permeation times.
Clinical Evidence
No clinical data. Bench testing only. Performance demonstrated via physical property testing (ASTM D6319-10), powder residual (ASTM D6124-06), freedom from holes (ASTM D5151-19), and chemical permeation resistance (ASTM D6978-05). Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).
Technological Characteristics
Material: Synthetic nitrile rubber. Form factor: Ambidextrous, light blue, sizes XS-XL. Standards: ASTM D6319-10 (physical), ASTM D6124-06 (powder), ASTM D5151-19 (holes), ASTM D6978-05 (permeation). Non-sterile. Single-use. No software or energy source.
Indications for Use
Indicated for use as a disposable patient medical examination glove worn on the examiner's hand or finger to prevent contamination between examiner and patient. Suitable for use with specific chemotherapy drugs and fentanyl citrate.
Regulatory Classification
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.
Predicate Devices
- Blue Colored, Powder Free Nitrile Patient Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)
Related Devices
- K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl · Anhui Powerguard Technology Co., Ltd. · Jan 12, 2024
- K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate · Better Care Plastic Technology Co., Ltd. · Mar 18, 2025
- K242812 — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) · Nb Medical Company Limited · Oct 12, 2024
- K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) · Better Care Plastic Technology Co., Ltd. · Aug 27, 2022
- K213408 — BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free · Meditech Gloves Sdn Bhd · Apr 17, 2022
Submission Summary (Full Text)
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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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FORM FDA 3881 (6/20)
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PSC Publishing Services (301) 443-6740 E
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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 Glove<br>Patient Examination Gloves, Specialty<br>Fentanyl 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 device<br>K192954 | Subject device<br>K220088 | |
| Regulation<br>Number | | | 21 CFR 880.6250 | 21 CFR 880.6250 | Same. |
| Product Code | | | LZA, LZC, QDO | LZA, LZC,<br>QDO,OPJ | Similar |
| Material | ASTM-D6319-10 | | Synthetic Nitrile<br>rubber | Synthetic Nitrile<br>rubber | Same. |
| Size | ASTM-D6319-10 | | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same. |
| Physical<br>Dimension | ASTM-D6319-10 | | Length:<br>Min 240mm<br>Thickness Palm &<br>finger:<br>Min: 0.05<br>Width by sizes:<br>XS - 70mm<br>S - 80mm<br>M - 95mm<br>L -110mm<br>XL - 120mm<br>Tolerance:<br>± 10mm | Length<br>Min: 240mm<br>Thickness Palm<br>& finger:<br>Min: 0.05<br>Width by sizes:<br>XS - 70mm<br>S - 80mm<br>M - 95mm L<br>L - 110mm<br>XL - 120mm<br>Tolerance:<br>± 10mm | Similar<br>Meeting the<br>requirements of<br>Dimension<br>under ASTM-<br>D6319-10. |
| Physical<br>Properties | ASTM-D6319-10 | | Tensile Strength<br>Before Aged:<br>Min: 14MPa<br>After Aged:<br>Min: 14MPa<br>Ultimate<br>Elongation:<br>Before aged:<br>Min 500%<br>After aged:<br>Min 400% | Tensile Strength<br>Before Aged:<br>Min: 14MPa<br>After Aged:<br>Min: 14MPa<br>Ultimate<br>Elongation:<br>Before aged:<br>Min 500%<br>After aged:<br>Min 400% | Similar<br>Meeting the<br>requirements of<br>physical<br>properties<br>under ASTM-<br>D6319-10. |
| Powder<br>Content | ASTM-D6124-<br>06(2017) | Powder Amount:<br>$\leq 2mg$ | Powder Amount:<br>$\leq 2mg$ | Similar<br>Meeting the<br>requirements of<br>Powder Content<br>under ASTM-<br>D6124-<br>06(2017). | |
| Freedom from<br>Holes<br>(Watertight<br>@1000ml) | 21 CFR 800.20<br>ASTM D5151 | Meets ASTM<br>D6139-10 and<br>ASTM D5151-06<br>requirements of<br>AQL 2.5 | AQL .2,5 | Similar<br>Meeting the<br>freedom from<br>holes<br>requirement<br>under ASTM-<br>D5151 | |
| Color | No standards<br>requirements | Blue | Blue | Similar<br>Both are similar<br>in color | |
| Single Use | Designated as<br>single use gloves | Single use | Sigle use | Same. Both are<br>single use<br>gloves. | |
| Sterility | Designated as non-<br>sterile gloves | No sterility report<br>as sold as non-<br>sterile | No sterility<br>report as sold as<br>non-sterile | Same. Both are<br>non-sterilized<br>Gloves | |
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 |
|------------------------------------------|------------------------|---------------|--------------------------------------------------|---------------------------|---------------------------------------|
| Chemotherapy<br>Drugs Permeation<br>Test | ASTM<br>D6978-<br>05 | | Predicate device | Subject device<br>K220088 | |
| Chemotherapy Drug | Concentration<br>mg/ml | | Minimum Breakthrough<br>Detection Time (Minutes) | | |
| Cisplatin | 1.0 | | ≥ 240 | > 240 | Similar |
| Cyclophosphamide<br>(Cytoxan) | 20.0 | | ≥ 240 | > 240 | The chemotherapy<br>drugs 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<br>(BCNU) | 3.3 | 18.2 | 24.3 | |
| *ThioTepa | 10.0 | 57.3 | 48.6 | |
| Fentanyl Citrate<br>Injection | *100 mcg/2ml | ≥ 240 | > 240 | |
| Characteristic | 510(K)<br>Number | Device Performance | | Comparison result |
| | | Predicate device<br>K192954 | Subject device<br>K220088 | |
| Warning Statement | | Warning:<br>Please note that the<br>following drugs have<br>extremely low<br>permeation times<br>Carmustine (BCNU):<br>18.2 minutes and<br>ThioTepa: 57.3<br>minutes | WARNING.<br>Please note that the<br>following drugs have<br>extremely low<br>permeation times<br>Carmustine (BCNU, 3.3<br>mg/ml: 24.3 minutes and<br>ThioTepa,10.0mg/ml :<br>48.6 minutes<br><br>Do not use with<br>Carmustine and<br>ThioTepa | Similar<br>The<br>chemotherapy<br>drugs tested<br>have similar<br>breakthrough<br>detection times<br>and the drug<br>with low<br>permeation time. |
# Table 3: Biocompatible Characteristic & Indication for Use Comparison Table
| Characteri<br>stics | 510(K)<br>Number | Device Performance | | Comparison result |
|----------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Standards | Predicate device | Subject device | |
| Biocomp<br>atibility | Primary Skin<br>Irritation<br>ISO 10993-<br>10:2010 | Passed.<br>Under the<br>conditions of the<br>study, the subject<br>device is non-<br>Irritating | Passed.<br>Under the<br>conditions of the<br>study, the subject<br>device is non-<br>irritating | Same.<br>Both are tested to<br>be non-irritant. |
| | Dermal<br>Sensitization<br>ISO 10993- | Passed.<br>Under the condition<br>of the study, the | Passed.<br>Under the condition<br>of the study, the | Same.<br>Both are tested to<br>be non-sensitizer |
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| 10: 2010 | subject device is<br>non-sensitizer | subject device is<br>non-sensitizer | subject device is<br>non-sensitizer |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Cytotoxicity<br>ISO 10993-5:<br>2009 | Exhibits severe<br>cytotoxicity<br>reactivity at 100%,<br>and 66% extract<br>concentrations and<br>no cytotoxicity<br>reactivity at 44%,<br>30%, 20% and 15%<br>extract<br>concentrations<br>under the condition<br>of this test. | It is concluded that,<br>undiluted, 1:2 and<br>1:4 dilution is<br>cytotoxicity and the<br>dilution 1:8 and 1:16<br>and 1:32 us non-<br>cytotoxic. | Same |
| Acute<br>Systemic<br>toxicity<br>ISO 10993-<br>11: 2017 | Under the condition<br>of the study, no<br>evidence of<br>systemic toxicity | Under the conditions<br>of the study, the<br>subject showed no<br>adverse biological<br>reaction | Same.<br>Both are tested to<br>be non-systemic<br>toxicity |
| Characteristics | Device Performance | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication<br>for Use | Predicate device | Subject device | Comparison<br>result |
| | 510(K) Number: K192954 | 510(K) Number: K220088 | |
| | The Blue Colored, Powder Free<br>Nitrile Examination Gloves, Non-<br>sterile, and Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate is a specialty medical glove<br>which is a disposable device<br>intended for medical purpose that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between examiner and patient. The<br>gloves was tested for use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate as per ASTM D6978-05<br>Standard Practice for Assessment of<br>Medical Gloves to Permeation by<br>Chemotherapy Drugs.<br><br>Tested chemotherapy drugs are as<br>follows: | Powder free Nitrile<br>Examination Gloves, Non-<br>Sterile and tested for use<br>with Chemotherapy Drugs<br>and Fentanyl Citrate is a<br>patient medical exam<br>gloves which is a disposal<br>device intended for medical<br>purposes that is worn on<br>the examiners' hand or<br>finger to prevent<br>contamination between<br>examiner and patient.<br><br>The glove was tested for<br>use with Chemotherapy<br>Drugs and Fentanyl<br>Citrate as per ASTM-<br>D6978-05 Standard<br>Practice for Assessment of<br>Medical Gloves to permeation<br>by chemotherapy Drugs | Similar<br>Both<br>indication<br>for use is<br>similar. |
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| Average Breakthrough Detection Time (minutes) | Tested Chemotherapy Drugs and Concentration |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cisplatin 1.0 mg/ml - ≥ 240<br>Cyclophosphamide (Cytoxan) (20.0 mg/ml) - ≥ 240<br>Dacarbazine (DTIC) (10.0mg/ml) - ≥ 240<br>Doxorubicin Hydrochloride (2.0mg/ml) - ≥ 240<br>Etoposide (20.0 mg/ml) - ≥ 240<br>Fluorouracil (50.0 mg/ml) - > 240<br>Paclitaxel (Taxol) (6.0 mg/ml) – > 240<br>Carmustine (BCNU) 3.3mg/ml 18.2<br>Thiotepa (THT) 10.0mg/ml 57.3 | Minimum Breakthrough Detection Times (Minutes)<br>Cisplatin 1.0mg/ml - > 240<br>Cyclophosphamide (Cytoxan) 20.0mg/ml - > 240<br>Dacarbazine 10.0mg/ml - > 240<br>Doxorubicin HCI 2.0mg/ml - > 240<br>Etoposide 20.0mg/m - > 240<br>Fluorouracil 50.0mg/ml -> 240<br>Ifosfamide 50.0mg/ml - > 240<br>Methotrexate 25.0mg/ml - > 240<br>Mitomycin C 0.5mg/ml - > 240.0<br>Mitoxantrone 20.0mg/ml - > 240<br>Paclitaxel - 6.0mg/ml > 240<br>Vincristine Sulfate -> 240<br>Carmustine (BCNU) 3.3mg/ml - 24.3<br>Thiotepa 10.0mg/ml - 48.6<br>Fentanyl Citrate Injection (100mcg/2ml) - > 240 |
| Tested Fentanyl Citrate is as follows:<br>Average Breakthrough Detection Time (minutes)<br>Fentanyl Citrate Injection 100.0 mg/2ml ≥ 240 | |
| Please note that the following drugs have extremely low permeation times:<br>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:<br>Carmustine (BCNU) 3.3 mg/ml 24.3 minutes and Thiotepa 10.0mg/ml 48.6 minutes<br>Do 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:
| Standar<br>d | Purpose | Acceptance Criteria | Result /<br>Conclusion |
|--------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| ASTM<br>D6319<br>-10 | Physical<br>Dimension | Length:<br>Min 240mm Thickness Palm & finger:<br>Min 0.05mm<br>Width by sizes: XS - 70mm<br><br>S - 80mm M - 95mm<br>L - 110mm<br>Tolerance:<br>$\pm$ 10mm | Passed |
| ASTM<br>D6319-<br>10 | Physical<br>Properties | Tensile Strength Before<br>Aged: Min: 14MPa<br><br>After Aged:<br>Min: 14MPa Ultimate<br>Elongation: Before aged:<br>Min 500%<br><br>After aged: Min 400% | Passed |
| ASTM<br>D6124<br>-06<br>(2017) | Powder<br>Residual | Powder Amount:<br>< 2mg | Passed |
| ASTM<br>D5151-<br>19 | Freedom<br>from Holes<br>(Watertight<br>@1000ml) | AQL 2.5 | Passed |
| ISO<br>10993-<br>10:201<br>0 | Irritation and<br>delayed-type<br>hypersensitivity | No Skin sensitization and<br>irritation | No skin<br>sensitization and<br>irritation, Passed |
| ISO<br>10993-<br>5:<br>2009 | Cytotoxicity | No Cytotoxicity Reaction | Cytotoxicity reaction,<br>Failed |
{13}------------------------------------------------
| ISO<br>10993-<br>11:<br>2017 | Acute<br>Systemic<br>toxicity | No adverse biological<br>reaction | | Passed | |
|------------------------------|-------------------------------|-----------------------------------|------------------------------|-------------------------------------|---------------------------------------------|
| ASTM<br>D6978 | Chemical<br>Permeation | Chemotherapy<br>Drugs | Concentrati<br>on<br>(mg/ml) | Breakthroug<br>h Time In<br>Minutes | Observatio<br>n |
| | | Cisplatin | 1.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Cyciophospha<br>mide | 20.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Dacarbazine | 10.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Doxorubicin<br>HCI | 2.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Etoposide | 20.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Fluorouracil | 50.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Ifosfamide | 50.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Methotrexate | 25.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Mitomycin C | 0.5 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Mitoxantrone | 2.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Paclitaxel | 6.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
| | | Vincristine<br>Sulfate | 1.0 | > 240 | Slight<br>swelling<br>and no<br>degradation |
{14}------------------------------------------------
| Carmustine<br>(BCNU) | 3.3 | 24.3<br>(25.3,27.4,24 | Moderate<br>swelling |
|----------------------|-----------|-----------------------|----------------------|
| | | .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.
