Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)

K212613 · Koon Seng Sdn Bhd · LZA · Dec 21, 2021 · General Hospital

Device Facts

• Record ID: K212613
• Device Name: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
• Applicant: Koon Seng Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Dec 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy drugs and the Opioid Fentanyl citrate.

Device Story

Nitrile synthetic, blue, non-sterile, disposable, single-use examination glove. Used by healthcare professionals to prevent cross-contamination between examiner and patient. Tested for permeation resistance against chemotherapy drugs and Fentanyl citrate per ASTM D6978-05 (2019). Provides barrier protection; users must consult drug labeling/SDS to determine appropriate protection levels. Warning: Do not use with Carmustine or Thiotepa due to low breakthrough times.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6978-05 (2019) for chemotherapy/opioid permeation, ASTM D412/D573 for physical properties, ASTM D5151 for water-leak (AQL 1.5), and ASTM D6124 for residual powder. Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Nitrile synthetic material; blue color; non-sterile; powder-free. Dimensions and physical properties meet ASTM D6319-10(2019). Permeation resistance tested per ASTM D6978. Biocompatibility per ISO 10993-10 and ISO 10993-11. Standalone device.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand or finger to prevent cross-contamination between examiner and patient. Tested for use with specific chemotherapy drugs and the opioid 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 Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)

Submission Summary (Full Text)

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December 21, 2021

Koon Seng Sdn Bhd % Wava Truscott President Truscott MedSci Associates, LLC. 180 Burkemeade Ct. Roswell, Georgia 30075

Re: K212613

Trade/Device Name: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QPO Dated: November 15, 2021 Received: November 22, 2021

Dear Wava Truscott:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Clarence W. Murray, III, PhD 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)

## K212613

#### Device Name

Trade Name: Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and the Opiod Fentanyl Citrate (Blue)

Indications for Use (Describe) A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specially glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.

| | | | Chemotherapy Drugs and the opioid Fentanyl citrate were tested for breakthrough detection times: |
|--|--|--|--------------------------------------------------------------------------------------------------|
|--|--|--|--------------------------------------------------------------------------------------------------|

| TEST<br>CHEMOTHERAPY DRUG | CONCENTRATION<br>TESTED | MINIMUM BREAKTHROUGH<br>DETECTION TIME (MINUTES) |
|----------------------------|-------------------------|--------------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml | 13.0 |
| Cisplatin | 1.0 mg/ml | No Breakthrough Up To 240 minutes |
| Cyclophosphamide (Cyloxan) | 20.0 mg/ml | No Breakthrough Up To 240 minutes |
| Cytarabine | 100.0 mg/ml | No Breakthrough Up To 240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml | No Breakthrough Up To 240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | No Breakthrough Up To 240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | No Breakthrough Up To 240 minutes |
| Fluorouracil | 50.0 mg/ml | No Breakthrough Up To 240 minutes |
| Ifosfamide | 50.0 mg/ml | No Breakthrough Up To 240 minutes |
| Methotrexate | 25.0 mg/ml | No Breakthrough Up To 240 minutes |
| Mitomycin C | 0.5 mg/ml | No Breakthrough Up To 240 minutes |
| Mitoxantrone | 2.0 mg/ml | No Breakthrough Up To 240 minutes |
| Pacitaxel (Taxol) | 6.0 mg/ml | No Breakthrough Up To 240 minutes |
| Thiotepa | 10.0 mg/ml | 37.9 |
| Vincristine Sulfate | 1.0 mg/ml | No Breakthrough Up To 240 minutes |

Important: Carmustine and Thiolepa have extremely low minimal breakthrough times of 13.0 minutes and 37.9 minutes respectively. Warning: Do not use with Carmusline or Thiotepa.

| TEST OPIOID DRUG | CONCENTRATION<br>TESTED | MINIMUM BREAKTHROUGH<br>DETECTION TIME (MINUTES) |
|-------------------------------|-------------------------|--------------------------------------------------|
| Fentanyl Citrate (Injectable) | 100.0 mg/2ml | No Breakthrough up to 240 minutes |

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo featuring two golden hands overlapping each other, set against a black background. The logo is encircled by a golden ring, and the text "Delivering Quality Excellence in Gloves" is written around the ring. The text is in a smaller font size and follows the curve of the circle.

QUALITY, TRANSPARENCY, PARTNER

#### OON SENG SDN. BHD = (107051-H)

(A member of the KS Group) Corporate Sales Office: 1321, 13th Floor, BlockA, Lift Lobby &, Damancara Intan No.1,
Jin. SS 20/27, 47400 Petaling Jaya, Selangor. Factory 1 : PTD 3274, Batu 41/2, Jalan Bakri, 84000 Muar, Johor, Factory 2 : PTD 16058, Kaw. Perindustrian Tangkak, 84900 Tangkak, Johor.

Email : [e-mail] Website : www.koonseng.com Tel : [phone]

Tel : [phone] Fax: [phone] Tel: [phone] Fax: [phone]

Image /page/3/Picture/6 description: The image contains several certification logos. There is an SMG logo, a CE logo, an ISO 22000 registered logo, and an ISO 13485 registered logo. These logos likely indicate that the product or company associated with the image meets certain standards for quality, safety, or environmental management.

# K212613: 510(k) Summary

| 1.0 | Submitter | | | |
|-----|------------------------------------------------------|---|--------------------------------------------------------------------------------------------------------------------------------------|--|
| | Name | : | Koon Seng, Sdn. Bhd. | |
| | Address | : | PTD 16058, Kawasan Perindustrian Tangkak,<br>84900 Tangkak, Johor, Malaysia | |
| | Contact | : | Yeo Pai Shuang | |
| | Phone No. | : | [phone] | |
| | Fax No. | : | [phone] | |
| | Date of Preparation | : | June 29, 2021 | |
| 2.0 | Name of the Device | | | |
| | Common Name | : | Nitrile Powder Free Examination Glove | |
| | Trade Name | : | Powder Free Nitrile Examination Gloves, Non-sterile,Tested for Use<br>with Chemotherapy Drugs and the Opioid Fentanyl Citrate (Blue) | |
| | Classification Name | : | Patient Examination Glove Specialty (21CFR 880.6250) | |
| | Product Codes | : | LZA, LZC, OPJ, QDO | |
| | Device Class | : | Class I | |
| 3.0 | Predicate: Identification of Legally Marketed Device | | | |
| | Predicate 510(k) No. | : | K192954 | |
| | Trade Name | : | Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with<br>Chemotherapy Drugs and Fentanyl Citrate | |
| | Owner | : | Comfort Rubber Gloves Industries Sdn. Bhd. | |
| | Product Codes | : | LZA, LZC, QDO | |
| | Device Class | : | Class I | |

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Image /page/4/Picture/0 description: The image shows the logo for Koon Seng. Above the name is the text "Quality - Transparency - Partnership". Below the name is the text "Since 1987".

#### 4.0 Description of Subject Device

The K212613 gloves are produced as nitrile synthetic gloves. They are manufactured without natural rubber latex. The nitrile gloves are blue in color, disposable, single-use only, non-sterile, medical examination gloves. K212613 meets all the requirements of ASTM D6978-10(2019) Standard Specifications for Examination Gloves for Medical Applications. They have been tested for use with chemotherapy drugs and the opioid Fentanyl citrate, both of which were evaluated using ASTM D6378-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

#### 5.0 Indications for Use

A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy drugs and the Opioid Fentanyl citrate.

| Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time<br>(minutes) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/mL | 13 min. |
| Cisplatin | 1.0 mg/mL | >240 min. |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240 min. |
| Cytarabine | 100 mg/mL | >240 min. |
| Dacarbazine | 10.0 mg/mL | >240 min. |
| Doxorubicin | 2.0 mg/mL | >240 min. |
| Etoposide | 20.0 mg/mL | >240 min. |
| Fluorouracil | 50.0 mg/mL | >240 min. |
| Ifosfamide | 50.0 mg/mL | >240 min. |
| Methotrexate | 25.0 mg/mL | >240 min. |
| Mitomycin C | 0.5 mg/mL | >240 min. |
| Mitoxantrone | 2.0 mg/mL | >240 min. |
| Paclitaxel | 6.0 mg/mL | >240 min. |
| ThioTepa | 10.0 mg/mL | 37.9 min |
| Vincristine Sulfate | 1.0 mg/mL | >240 min. |
| Important: Carmustine and ThioTepa have extremely low minimum breakthrough times of<br>13.0 minutes and 37.9 minutes respectively. | | |
| Warning: Do not use with Carmustine or ThioTepa. | | |
| Test Opioid Drug | Concentration | Minimum Breakthrough Detection Time<br>(minutes) |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min. |
| Please Note: Glove used for protection against possible Chemotherapy Drug exposure<br>should be selected specifically for the type of drugs used. Users should review drug labeling<br>or material safety data sheets for the drugs being used to determine an adequate level of<br>protection. | | |

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Image /page/5/Picture/0 description: The image shows the logo for Koon Seng. The logo includes the words "Quality • Transparency • Partnership" at the top. Below that is the name "KOON SENG" in large, bold letters. Finally, the words "Since 1987" are at the bottom of the logo.

# Technological Characteristic Comparison:

Shown below is a comparison of The Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) and Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

## Glove Comparison Table":

| Subject | Standards | Koon Seng Subject<br>Device<br>510(k): K212613 | Predicate Device:<br>510(k): K192954 | Comparison K212613<br>Subject glove to<br>Predicate K192954 |
|-----------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturers | NA | Koon Seng Sdn. Bhd. | Comfort Rubber Gloves<br>Industries Sdn. Bhd. | Different |
| Trade Name | NA | Powder Free Nitrile<br>Examination Gloves, Non-<br>Sterile, Tested for Use with<br>Chemotherapy Drugs and the<br>Opiod F<br>entanyl Citrate (Blue) | Blue Colored, Powder Free<br>Nitrile Examination Glove<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Different |
| Common<br>Name | ASTM D6319 -<br>10(2019) | Nitrile Powder free Patient<br>Examination Glove | Nitrile Patient<br>Examination Glove | Similar |
| Device Class | 21 CFR<br>880.6250 | Class 1 | Class 1 | Same |
| Base Material | NA | Nitrile | Nitrile | Same |
| Color | NA | Blue | Blue | Same |
| Product Codes | 21 CFR<br>880.6250 | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar OPJ is new: denotes<br>tested with Chemotherapy<br>drugs to further define the<br>LZC specialty designation |
| Sizes offered | ASTM D3767 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same |
| Dimensions: | ASTM D6319 -<br>10(2019) | Meets | Meets | Same |
| Sterile v.<br>Non-Sterile | NA | Non-Sterile | Non-Sterile | Same |
| Prescription or<br>OTC | NA | OTC | OTC | Same |
| Single Use-<br>Disposable | NA | Single use-Disposable | Single use-Disposable | Same |
| Thickness:<br>Finger & palm | ASTM D6319 -<br>10(2019) | Meets | Meets | Same |
| Before aging<br>Physical<br>Properties | ASTM D412<br>ASTM D6319 -<br>10(2019) | Meets | Meets | Same |
| After aging<br>Physical<br>Properties | ASTM D412<br>ASTM D6319 | Meets | Meets | Same |
| Freedom from<br>Holes | ASTM D5151<br>ASTM D6319 | Meets AQL 1.5 | Meets AQL 1.5 | Same |
| Subject | Standards | Koon Seng Subject<br>Device<br>510(k): K212613 | Predicate Device:<br>510(k): K192954 | Comparison K212613<br>Subject glove to<br>Predicate K192954 |
| Powder-Free | ASTM D6124<br>< 2mg/glove | Meets | Meets | Same |
| Intended Use<br>(part of<br>Indications for<br>Use) | | A Nitrile powder free<br>examination glove is a<br>disposable device intended<br>for medical purposes, worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between<br>examiner and patient. This<br>specialty glove has also been<br>tested for use with<br>Chemotherapy drugs and the<br>Opioid Fentanyl citrate. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner. | Similar |
| Indications for<br>Use<br>Chemotherapy | ASTM D6978 | Chemotherapy drugs:<br>All >240min Breakthrough<br>Times except Carmustine &<br>ThioTEPA<br>• Cisplatin, 1mg/ml<br>• Cyclophosphamide<br>(Cytoxan), 20mg/ml<br>• Cytarabine, 100mg/ml<br>• Dacarbazine, 10mg/ml<br>• Doxorubicin HCL, 2mg/ml<br>• Etoposide, 20mg/ml<br>• Fluorouracil, 50mg/ml<br>• Ifosfamide, 50mg/ml<br>• Methotrexate, 25mg/ml<br>• Mitomycin C, 0.5mg/ml<br>• Mitoxantrone, 2mg/ml<br>• Paclitaxel, 6mg/ml<br>• Vincristine Sulfate,mg/ml<br><br>• Carmustine (BCNU), 3.3<br>mg/ml:<br>Breakthrough: 13 min.<br><br>• ThioTepa, 10mg/ml<br>Breakthrough: 37.9 min. | Chemotherapy drugs:All<br>>240min Breakthrough<br>Times except Carmustine &<br>ThioTEPA<br>•Cisplatin 1mg/ml<br>• Cyclophosphamide<br>(Cytoxan) 20mg/ml<br>• Dacarbazine (DTIC) 10<br>mg/ml<br>• Doxorubicin HCL, 2mg/ml<br>• Hydrochloride 2mg/ml<br>• Etoposide (Toposar)<br>20mg/ml<br>• FluorouracilS0mg/ml<br>• Paclitaxel (Taxol)<br>6mg/ml<br><br>• Carmustine (BCNU) 3.3<br>mg/ml:<br>Breakthrough: 18.2 min.<br><br>• ThioTepa (THT) 10mg/ml:<br>Breakthrough: 57.3 min. | Similar |
| Subject | Standards | Koon Seng Subject<br>Device<br>510(k): K212613 | Predicate Device:<br>510(k): K192954 | Comparison K212613<br>Subject glove to<br>Predicate K192954 |
| Cautions &<br>Warnings | | Important: Carmustine and<br>ThioTEPA have extremely low<br>minimal breakthrough times of<br>13.0 minutes and<br>37.9 minutes respectively.<br><b>Warning:</b> Do not use with<br>Carmustine or ThioTepa | Please note that the<br>following drugs have<br>extremely low permeation<br>times: Carmustine (BCNU):<br>18.2minutes and Thiotepa:<br>57.3 minutes. <b>Warning:</b><br>Do not use with<br>Carmustine. | Similar: except Subject<br>device added ThioTepa to<br>the " <b>Warning:</b> Do not use<br>with..." listing. Technically,<br>it is not required to do so<br>as the cut-off to require<br>the warning is below 30<br>minutes. |
| Indications for<br>Use: Fentanyl | ASTM D6978 | Fentanyl Citrate (Injectable)<br>100mg/2ml:Minimum<br>breakthrough time: >240 | Fentanyl Citrate 100mg/2ml:<br>Minimum breakthrough time:<br>>240 | Similar: Fentanyl Citrate<br>concentration & diluent<br>same. US DEA required<br>testing street injectable<br>term by test lab in test<br>results |
| Biocompatibility | ISO 10993-<br>11: Tests<br>for Systemic<br>Toxicity | Passes<br>Under the conditions of The<br>Systemic Toxicity test the<br>predicate glove showed no<br>adverse biological reaction. | (Used Accepted Alternative:<br>ISO 10993-5 (Cytotoxicity) | Similar: Used Different<br>alternative<br>biocompatibility<br>test method: Both<br>acceptable |
| | ISO 10993-5<br>Cytotoxicity | (Used Accepted Alternative:<br>ISO 10993-11 Acute Systemic<br>Toxicity) | Passed at: Exhibits severe<br>cytotoxicity reactivity at<br>100%, and 66% extract<br>concentrations and no<br>cytotoxicity reactivity at<br>44%, 30%, 20% and 15%<br>extract concentrations<br>under the condition of this<br>test. | Similar: Used Different<br>Accepted Alternative<br>Biocompatibility test |
| | ISO 10993-10<br>Skin<br>Irritation | Passes<br>Under conditions of this<br>study, subject glove is non-<br>irritating | Passes<br>Under conditions of the<br>study, the device is non-<br>irritating | Same |
| | ISO 10993-10<br>Dermal<br>Sensitization | Passes<br>Under conditions of this<br>study, subject glove is a<br>non-sensitizer | Passes<br>Under conditions of the<br>study, the device is non-<br>sensitization | Same |

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## Summary of Non-Clinical Performance Tests conducted

| Test Method | Purpose | Acceptance Criteria | Results |
|--------------------------------------|-------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| ASTM D6978-2005<br>(2019) | Permeation by<br>Chemotherapy Drugs | Minimum detection time >240<br>minute | All Chemotherapy Drugs & the<br>Opioid Passed >240min. except<br>Carmustine & ThioTepa |
| ASTM D412-2016<br>ASTM D573-04(2019) | Physical properties | Tensile strength<br>(min=14Mpa); Elongation (min<br>400%) | Pass |
| ASTM D5151-19 | Water-leak test | AQL 1.5 (ISO 2859-1) | Pass |
| ASTM D6124-06(2017) | Residual powder test | <2mg/glove | Pass |
| ISO 10993-10:2010<br>(2016) | Dermal Irritation | Under conditions of this study,<br>the subject device is non-<br>irritating | Pass |
| ISO 10993-10:2010<br>(2016) | Skin Sensitization | Under conditions of this study,<br>the subject device is non-<br>sensitizing | Pass |

#### Non-clinical performance testing method full Titles:

- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— Tension O
- O ASTM D573 Test Method for Rubber—Deterioration in an Air Oven x ASTM D3578 Specificationfor Rubber Examination Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application O
- ASTM D5151 Test Method for Detection of Holes in Medical Gloves O
- O ASTM D6124 Test Method for Residual Powder on Medical Gloves
- O ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show that under the conditions of the testing, there is no difference in physical attributes between the proposed device and the predicate device.
- O ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

Biocompatibility Testing was performed utilizing: ISO 10993 Biological Evaluation of Medical Devices

- ISO 10993 Part 10: Tests for Irritation and Sensitization. Both Skin Irritation and Dermal O Magnuson/Kligman Sensitization performed.
- ISO 10993 Part 11: Tests for assessment of Systemic Toxicity O

#### No human clinical or animal performance testing was performed.

Conclusion: The conclusions drawn from comparing the physical attributes and the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as, or better than, the legally marketed predicate device.