Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Q: Who is the manufacturer of Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Professional Latex Sdn Bhd filed the 510(k) submission for Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088).

Q: What is the FDA product code for Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K220088 · Professional Latex Sdn Bhd · LZA · Mar 30, 2023 · General Hospital

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

Indications for 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)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) {3}------------------------------------------------ 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 E {4}------------------------------------------------ ## 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 Patient Examination Gloves, Specialty 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 | {5}------------------------------------------------ #### 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 | {6}------------------------------------------------ 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. {7}------------------------------------------------ | Characteristics | 510(K) | | Device Performance | | Comparison Result | |--------------------------------------------------|--------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | | Standards | Number | Predicate device K192954 | Subject device K220088 | | | Regulation Number | | | 21 CFR 880.6250 | 21 CFR 880.6250 | Same. | | Product Code | | | LZA, LZC, QDO | LZA, LZC, QDO,OPJ | Similar | | Material | ASTM-D6319-10 | | Synthetic Nitrile rubber | Synthetic Nitrile rubber | Same. | | Size | ASTM-D6319-10 | | Extra Small Small Medium Large Extra Large | Extra Small Small Medium Large Extra Large | Same. | | Physical Dimension | ASTM-D6319-10 | | Length: Min 240mm Thickness Palm & finger: Min: 0.05 Width by sizes: XS - 70mm S - 80mm M - 95mm L -110mm XL - 120mm Tolerance: ± 10mm | Length Min: 240mm Thickness Palm & finger: Min: 0.05 Width by sizes: XS - 70mm S - 80mm M - 95mm L L - 110mm XL - 120mm Tolerance: ± 10mm | Similar Meeting the requirements of Dimension under ASTM- D6319-10. | | Physical Properties | ASTM-D6319-10 | | Tensile Strength Before Aged: Min: 14MPa After Aged: Min: 14MPa Ultimate Elongation: Before aged: Min 500% After aged: Min 400% | Tensile Strength Before Aged: Min: 14MPa After Aged: Min: 14MPa Ultimate Elongation: Before aged: Min 500% After aged: Min 400% | Similar Meeting the requirements of physical properties under ASTM- D6319-10. | | Powder Content | ASTM-D6124- 06(2017) | Powder Amount: $\leq 2mg$ | Powder Amount: $\leq 2mg$ | Similar Meeting the requirements of Powder Content under ASTM- D6124- 06(2017). | | | Freedom from Holes (Watertight @1000ml) | 21 CFR 800.20 ASTM D5151 | Meets ASTM D6139-10 and ASTM D5151-06 requirements of AQL 2.5 | AQL .2,5 | Similar Meeting the freedom from holes requirement under ASTM- D5151 | | | Color | No standards requirements | Blue | Blue | Similar Both are similar in color | | | Single Use | Designated as single use gloves | Single use | Sigle use | Same. Both are single use gloves. | | | Sterility | Designated as non- sterile gloves | No sterility report as sold as non- sterile | No sterility report as sold as non-sterile | Same. Both are non-sterilized Gloves | | Table 1: Technological Characteristic Comparison Table {8}------------------------------------------------ ## 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 Drugs Permeation Test | ASTM D6978- 05 | | Predicate device | Subject device K220088 | | | Chemotherapy Drug | Concentration mg/ml | | Minimum Breakthrough Detection Time (Minutes) | | | | Cisplatin | 1.0 | | ≥ 240 | > 240 | Similar | | Cyclophosphamide (Cytoxan) | 20.0 | | ≥ 240 | > 240 | The chemotherapy drugs tested have | | Dacarbazine | 10.0 | | ≥ 240 | > 240 | similar | | Doxorubicin HCI | 2.0 | | ≥ 240 | > 240 | breakthrough | {9}------------------------------------------------ | 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 Citrate Injection | *100 mcg/2ml | ≥ 240 | > 240 | | | Characteristic | 510(K) Number | Device Performance | | Comparison result | | | | Predicate device K192954 | Subject device K220088 | | | Warning Statement | | Warning: Please note that the following drugs have extremely low permeation times Carmustine (BCNU): 18.2 minutes and ThioTepa: 57.3 minutes | WARNING. Please note that the following drugs have extremely low permeation times Carmustine (BCNU, 3.3 mg/ml: 24.3 minutes and ThioTepa,10.0mg/ml : 48.6 minutes Do not use with Carmustine and ThioTepa | Similar The chemotherapy drugs tested have similar breakthrough detection times and the drug with low permeation time. | # Table 3: Biocompatible Characteristic & Indication for Use Comparison Table | Characteri stics | 510(K) Number | Device Performance | | Comparison result | |----------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------| | | Standards | Predicate device | Subject device | | | Biocomp atibility | Primary Skin Irritation ISO 10993- 10:2010 | Passed. Under the conditions of the study, the subject device is non- Irritating | Passed. Under the conditions of the study, the subject device is non- irritating | Same. Both are tested to be non-irritant. | | | Dermal Sensitization ISO 10993- | Passed. Under the condition of the study, the | Passed. Under the condition of the study, the | Same. Both are tested to be non-sensitizer | {10}------------------------------------------------ | 10: 2010 | subject device is non-sensitizer | subject device is non-sensitizer | subject device is non-sensitizer | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Cytotoxicity ISO 10993-5: 2009 | Exhibits severe cytotoxicity reactivity at 100%, and 66% extract concentrations and no cytotoxicity reactivity at 44%, 30%, 20% and 15% extract concentrations under the condition of this test. | It is concluded that, undiluted, 1:2 and 1:4 dilution is cytotoxicity and the dilution 1:8 and 1:16 and 1:32 us non- cytotoxic. | Same | | Acute Systemic toxicity ISO 10993- 11: 2017 | Under the condition of the study, no evidence of systemic toxicity | Under the conditions of the study, the subject showed no adverse biological reaction | Same. Both are tested to be non-systemic toxicity | | Characteristics | Device Performance | | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Indication for Use | Predicate device | Subject device | Comparison result | | | 510(K) Number: K192954 | 510(K) Number: K220088 | | | | The Blue Colored, Powder Free Nitrile Examination Gloves, Non- sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove 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 gloves 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: | 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 disposal device intended for medical purposes that is worn on the examiners' 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 | Similar Both indication for use is similar. | {11}------------------------------------------------ | Average Breakthrough Detection Time (minutes) | Tested Chemotherapy Drugs and Concentration | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cisplatin 1.0 mg/ml - ≥ 240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) - ≥ 240 Dacarbazine (DTIC) (10.0mg/ml) - ≥ 240 Doxorubicin Hydrochloride (2.0mg/ml) - ≥ 240 Etoposide (20.0 mg/ml) - ≥ 240 Fluorouracil (50.0 mg/ml) - > 240 Paclitaxel (Taxol) (6.0 mg/ml) – > 240 Carmustine (BCNU) 3.3mg/ml 18.2 Thiotepa (THT) 10.0mg/ml 57.3 | Minimum Breakthrough Detection Times (Minutes) Cisplatin 1.0mg/ml - > 240 Cyclophosphamide (Cytoxan) 20.0mg/ml - > 240 Dacarbazine 10.0mg/ml - > 240 Doxorubicin HCI 2.0mg/ml - > 240 Etoposide 20.0mg/m - > 240 Fluorouracil 50.0mg/ml -> 240 Ifosfamide 50.0mg/ml - > 240 Methotrexate 25.0mg/ml - > 240 Mitomycin C 0.5mg/ml - > 240.0 Mitoxantrone 20.0mg/ml - > 240 Paclitaxel - 6.0mg/ml > 240 Vincristine Sulfate -> 240 Carmustine (BCNU) 3.3mg/ml - 24.3 Thiotepa 10.0mg/ml - 48.6 Fentanyl 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 minutes Do not use with Carmustine and Thiotepa | {12}------------------------------------------------ #### 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 d | Purpose | Acceptance Criteria | Result / Conclusion | |--------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | ASTM D6319 -10 | Physical Dimension | Length: Min 240mm Thickness Palm & finger: Min 0.05mm Width by sizes: XS - 70mm S - 80mm M - 95mm L - 110mm Tolerance: $\pm$ 10mm | Passed | | ASTM D6319- 10 | Physical Properties | Tensile Strength Before Aged: Min: 14MPa After Aged: Min: 14MPa Ultimate Elongation: Before aged: Min 500% After aged: Min 400% | Passed | | ASTM D6124 -06 (2017) | Powder Residual | Powder Amount: < 2mg | Passed | | ASTM D5151- 19 | Freedom from Holes (Watertight @1000ml) | AQL 2.5 | Passed | | ISO 10993- 10:201 0 | Irritation and delayed-type hypersensitivity | No Skin sensitization and irritation | No skin sensitization and irritation, Passed | | ISO 10993- 5: 2009 | Cytotoxicity | No Cytotoxicity Reaction | Cytotoxicity reaction, Failed | {13}------------------------------------------------ | ISO 10993- 11: 2017 | Acute Systemic toxicity | No adverse biological reaction | | Passed | | |------------------------------|-------------------------------|-----------------------------------|------------------------------|-------------------------------------|---------------------------------------------| | ASTM D6978 | Chemical Permeation | Chemotherapy Drugs | Concentrati on (mg/ml) | Breakthroug h Time In Minutes | Observatio n | | | | Cisplatin | 1.0 | > 240 | Slight swelling and no degradation | | | | Cyciophospha mide | 20.0 | > 240 | Slight swelling and no degradation | | | | Dacarbazine | 10.0 | > 240 | Slight swelling and no degradation | | | | Doxorubicin HCI | 2.0 | > 240 | Slight swelling and no degradation | | | | Etoposide | 20.0 | > 240 | Slight swelling and no degradation | | | | Fluorouracil | 50.0 | > 240 | Slight swelling and no degradation | | | | Ifosfamide | 50.0 | > 240 | Slight swelling and no degradation | | | | Methotrexate | 25.0 | > 240 | Slight swelling and no degradation | | | | Mitomycin C | 0.5 | > 240 | Slight swelling and no degradation | | | | Mitoxantrone | 2.0 | > 240 | Slight swelling and no degradation | | | | Paclitaxel | 6.0 | > 240 | Slight swelling and no degradation | | | | Vincristine Sulfate | 1.0 | > 240 | Slight swelling and no degradation | {14}------------------------------------------------ | Carmustine (BCNU) | 3.3 | 24.3 (25.3,27.4,24 | Moderate 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.

Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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