Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs

K230002 · Mah Sing Healthcare Sdn. Bhd. · LZA · Mar 24, 2023 · General Hospital

Device Facts

• Record ID: K230002
• Device Name: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
• Applicant: Mah Sing Healthcare Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; black color; powder-free. Used by healthcare professionals in clinical settings to prevent cross-contamination between patient and examiner. Manufactured from acrylonitrile-butadiene copolymer dispersion. Surface treatment ensures smooth donning without powder. Available in five sizes (XS-XL). Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides barrier protection; does not require clinical data for clearance.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via ASTM D6124-06 (residual powder), ASTM D5151-19 (freedom from holes), ASTM D6319-19 (physical dimensions/properties), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Form: Ambidextrous, powder-free, black, non-sterile. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-10, ISO 10993-11. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

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

• Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs (K214110)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

March 24, 2023

Mah Sing Healthcare Sdn Bhd Ivan Tan Chee Wei Senior QA Manager Lot 6478, Lorong Sungai Puloh/KU6, Kawasan Industri Sungai Puloh, Klang. Selangor 42100 Malaysia

Re: K230002

Trade/Device Name: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: January 3, 2023 Received: January 3, 2023

Dear Ivan Tan Chee Wei:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Allan Gl

For 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K230002

Device Name

Nitrile Powder Free Black Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Test Chemotherapy Drugs are as follows:

| Test Chemotherapy Drugs Concentration | Minimum Breakthrough Detection Time in minutes |
|---------------------------------------|------------------------------------------------|
| *Carmustine 3.3mg/ml | 32.2 |
| Cisplatin 1mg/ml | >240 |
| Cyclophosphamide 20mg/ml | >240 |
| Dacarbazine 10mg/ml | >240 |
| Doxorubicin, HCl 2mg/ml | >240 |
| Etoposide 20mg/ml | >240 |
| Fluorouracil 50mg/ml | >240 |
| Methotrexate 25mg/ml | >240 |
| Mitomycin 0.5mg/ml | >240 |
| Oxaliplatin 5mg/ml | >240 |
| Paclitaxel 6mg/ml | >240 |
| *Thiotepa 10mg/ml | 37.4 |
| Vincristine 1mg/ml | >240 |

Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 32.2 minutes (2)Thiotepa - 37.4 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 contains the logo for Mah Sing Healthcare. The words "MahSing" are in red, with the "M" being the largest letter. Below that, the word "HEALTHCARE" is in black. The logo is simple and professional.

# Premarket Notification [510(k)] No: K230002

| | 510 (K) SUMMARY |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.0 Device Name | Nitrile Powder Free Black Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs. |
| 2.0 Submitter name /<br>Contact details | Mah Sing Healthcare Sdn. Bhd<br>Lot 6478, Lorong Sungai Puloh/KU6,<br>Kawasan Industri Sungai Puloh,<br>Klang, Selangor 42100<br>MALAYSIA |
| | Contact Person Details:<br>Ivan Tan Chee Wei (Mr.)<br>E-mail: [e-mail]<br>Tel: [phone], Extn: 2213<br>Fax: [phone] |
| 3.0 Summary<br>Preparation Date | February 20, 2023 |
| 4.0 Device Name &<br>Classification | Trade Name: Nitrile Powder Free Black Patient Examination Gloves<br>Non-sterile, Tested for use with Chemotherapy Drugs |
| | Common Name: Nitrile Powder Free Patient Examination Glove |
| | Classification Name: Patient Examination Gloves Specialty<br>Polymer Patient Examination Gloves |
| | Device Classification: I |
| | Regulation Number: 21 CFR 880.6250 |
| | Panel: General Hospital |
| | Product Code: LZA, LZC, OPJ |
| 5.0 Identification of<br>The Legally Marketed<br>Device | Predicate Device Name: Nitrile Powder Free Blue Patient Examination<br>Gloves, Non-Sterile, Tested For Use With<br>Chemotherapy Drugs |
| | Predicate 510(K) Number: K214110 |
| | Manufacture's Name: Mah Sing Healthcare Sdn. Bhd |

MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

DrivingInnovation. Protecting Lives.

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Image /page/4/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the first letter of each word capitalized. Below that, the word "HEALTHCARE" is in black, with all letters capitalized. The logo is simple and modern, with a focus on the company's name and industry.

| 6.0 Description of Device | Nitrile Powder Free Black Patient Examination Gloves Non-sterile,<br>Tested For Use With Chemotherapy Drugs meets all the requirements of<br>ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR<br>880.6250. | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------|--|--|
| | The gloves are made from acrylonitrile-butadiene copolymer dispersion.<br>Inner surface of gloves undergoes surface treatment process to produce a<br>smooth surface that assists the user in donning the gloves without using<br>any lubricant such as powder on the glove surface. These gloves are black<br>in color and are powder free. The gloves are ambidextrous i.e., can be worn<br>on right hand or left hand, single use disposable devices that come in five<br>sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile<br>strength meet ASTM D 6319-19. | | | | |
| 7.0 Indications for Use | A patient examination glove is a disposable device intended for medical<br>purpose that is worn on the examiner's hand or finger to prevent<br>contamination between patient and examiner.<br>These gloves were tested for use with Chemotherapy Drugs as per<br>ASTM D6978-05 (2019), Standard Practice for Assessment of Medical<br>Gloves to Permeation by Chemotherapy Drugs:<br>Test Chemotherapy Drugs are as follows: | | | | |
| | Test Chemotherapy | Concentration | Minimum Breakthrough | | |
| | Drugs | | Detection Time in<br>minutes | | |
| | *Carmustine | 3.3mg/ml | 32.2 | | |
| | Cisplatin | 1 mg/ml | >240 | | |
| | Cyclophosphamide | 20 mg/ml | >240 | | |
| | Dacarbazine | 10 mg/ml | >240 | | |
| | Doxorubicin, HCl | 2 mg/ml | >240 | | |
| | Etoposide | 20 mg/ml | >240 | | |
| | Fluorouracil | 50 mg/ml | >240 | | |
| | Methotrexate | 25 mg/ml | >240 | | |
| | Mitomycin | 0.5 mg/ml | >240 | | |
| | Oxaliplatin | 5 mg/ml | >240 | | |
| | Paclitaxel | 6 mg/ml | >240 | | |
| | *Thiotepa | 10 mg/ml | 37.4 | | |
| | Vincristine | 1 mg/ml | >240 | | |

*Warning: Do not use with Carmustine and Thiotepa

### Note:

Please note that the following drugs have low permeation times:

- (1) Carmustine 32.2 minutes
(2) Thiotepa - 37.4 minutes.

MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

DrivingInnovation. Protecting Lives.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for "MahSing Healthcare". The word "MahSing" is in red, bold, and large font. Below it, the word "HEALTHCARE" is in black, bold, and a smaller font.

## 8.0 Summary of the Technological Characteristic of The Device

Nitrile Powder Free Black Patient Examination Gloves Non-sterile, Tested For Use with Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250

| Table | 1 |
|-------|---|
| | |

| Characteristics and<br>Parameters | Standard | Proposed Device | Predicate device | Comparison<br>Analysis |
|-------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------|
| 510(k) Number | - | K230002 | K214110 | - |
| Manufacturer | - | Mah Sing Healthcare Sdn.<br>Bhd. | Mah Sing Healthcare Sdn.<br>Bhd. | Same |
| Name of device | - | Nitrile Powder Free<br>Black Patient<br>Examination Gloves,<br>Non-Sterile, Tested for<br>use with chemotherapy<br>drugs and | Nitrile Powder Free<br>Blue Patient<br>Examination Gloves,<br>Non-Sterile, Tested for<br>use with chemotherapy<br>drugs | Similar |
| Device Classification<br>Name/Regulation Number | Patient Examination<br>Glove,<br>21 CFR Part 880.6250 | Patient Examination<br>Glove,<br>21 CFR Part 880.6250 | Patient Examination<br>Glove,<br>21 CFR Part 880.6250 | Same |
| Product Code | - | LZA, LZC, OPJ | LZA, LZC | Same |
| Classification | - | Class 1 | Class 1 | Same |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile | Nitrile | Same |
| Color | - | Black | Blue | Different |

DrivingInnovation. Protecting Lives.

MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

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Image /page/6/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, with the "M" and "S" capitalized. Below that, the word "HEALTHCARE" is in black, with all letters capitalized. The logo is simple and clean, with a focus on the company name.

| Characteristics and<br>Parameters | Standard | Proposed Device<br>(K230002) | Predicate device<br>(K214110) | Comparison<br>Analysis |
|--------------------------------------|---------------|-------------------------------------------|-------------------------------|--------------------------------------------------------------------------------|
| Chemotherapy Drug<br>Permeation Test | ASTM D6897-05 | | | |
| Test Chemotherapy<br>Drugs | Concentration | Minimum Breakthrough Detection Time (min) | | |
| *Carmustine | 3.3mg/ml | 32.2 | 24.8 | Similar<br>Below 240 minutes<br>permeation times |
| Cisplatin | 1 mg/ml | >240 | >240 | Similar |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | Similar |
| Dacarbazine | 10 mg/ml | >240 | >240 | Similar |
| Doxorubicin, HCl | 2 mg/ml | >240 | >240 | Similar |
| Etoposide | 20 mg/ml | >240 | >240 | Similar |
| Fluorouracil | 50 mg/ml | >240 | >240 | Similar |
| Methotrexate | 25 mg/ml | >240 | Not tested | Optional, Subject<br>device perform<br>additional<br>Chemotherapy drug<br>test |
| Mitomycin | 0.5 mg/ml | >240 | Not tested | Optional, Subject<br>device perform<br>additional<br>Chemotherapy drug<br>test |
| Oxaliplatin | 5 mg/ml | >240 | Not tested | Optional, Subject<br>device perform<br>additional<br>Chemotherapy drug<br>test |
| Paclitaxel | 6 mg/ml | >240 | >240 | Similar |
| *Thiotepa | 10 mg/ml | 37.4 | 38.4 | Similar<br>Below 240 minutes<br>permeation times |
| Vincristine | 1 mg/ml | >240 | >240 | Similar |

DrivingInnovation. Protecting Lives.

MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in a large, red, bold font. Below that, the word "HEALTHCARE" is in a smaller, black, bold font.

| Characteristics and<br>Parameters | Standard | Proposed Device<br>(K230002) | Predicate device<br>(K214110) | Comparison<br>Analysis |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Length<br>XS: Min.220mm<br>S: Min.220mm<br>M: Min.230mm<br>L: Min.230mm<br>XL: Min. 230mm | ASTM D 6319-19 | XS: 244 - 247mm<br>S: 243 - 248mm<br>M: 243 - 252mm<br>L: 243 - 249mm<br>XL: 243 - 249mm | 245 - 255mm | Similar |
| Width<br>XS:60mm - 80mm<br>S: 70mm – 90mm<br>M: 85mm - 105mm<br>L: 100mm – 120mm<br>XL:110mm - 130mm | ASTM D 6319-19 | XS: 76 - 78mm<br>S: 81 - 88mm<br>M: 95 - 99mm<br>L: 102 - 111mm<br>XL: 111 - 119mm | S: 83 - 85mm<br>M: 93 - 96mm<br>L: 105 - 109mm<br>XL: 116 - 118mm | Similar |
| Palm Thickness<br>(Minimum 0.05mm) | ASTM D 6319-19 | 0.06 - 0.07mm | 0.06 - 0.07mm | Similar |
| Finger Thickness<br>(Minimum 0.05mm) | ASTM D 6319-19 | 0.07 - 0.08mm | 0.08 - 0.11mm | Similar |
| Tensile Strength<br>(Before aging) Minimum<br>14 MPa | ASTM D 6319-19 | Average: 25.31MPa | Average: 21.96MPa | Similar |
| Tensile Strength<br>(After accelerated aging)<br>Minimum 14 MPa | ASTM D 6319-19 | Average: 26.38MPa | Average: 28.30MPa | Similar |
| Ultimate Elongation<br>(before aging) Minimum<br>500% | ASTM D 6319-19 | Average: 533% | Average: 537% | Similar |
| Ultimate Elongation<br>(after accelerated aging)<br>Minimum 400% | ASTM D 6319-19 | Average: 455% | Average: 449% | Similar |
| Freedom of Holes Meet<br>AQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 1.5 with G1 | Meet AQL 1.5 with G1 | Same |
| Residual powder test<br>(Less than 2mg/glove) | ASTM D 6124-06 | Average powder residue<br>for each size.<br>XS: 0.23mg/glove<br>S: 0.20mg/glove<br>M: 0.25mg/glove<br>L: 0.25mg/glove<br>XL: 0.30mg/glove | Average powder residue<br>for each size:<br>S: 0.32mg/glove<br>M: 0.28mg/glove<br>L: 0.32mg/glove<br>XL: 0.30mg/glove | Similar |
| Animal Irritation Test | ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for<br>irritation and skin<br>Sensitization | Passed.<br>Under the conditions of<br>study, not an irritant | Passed.<br>Under the conditions of<br>study, not an irritant | Same |
| Dermal Sensitization | ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Passed.<br>Under the conditions of<br>study, not a sensitizer | Passed.<br>Under the conditions of<br>study, not a sensitizer | Same |
| Acute Systemic Toxicity | ISO 10993-11<br>Biological evaluation<br>of medical devices -<br>Part 11: Tests for<br>systemic toxicity | Not induce acute systemic<br>toxicity | Not induce acute systemic<br>toxicity | Same |
| Characteristics and<br>Parameters | Standard | Proposed Device<br>(K230002) | Predicate device<br>(K214110) | Comparison<br>Analysis |
| Indication for use | - | Nitrile Powder Free Black<br>Patient Examination<br>Gloves, Non-Sterile,<br>Tested for Use with<br>Chemotherapy Drugs is a<br>patient examination glove<br>is a disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested<br>for use with<br>Chemotherapy Drugs as<br>per ASTM D6978-05<br>(2019), Standard Practice<br>for Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | Nitrile Powder Free Blue<br>Patient Examination<br>Gloves, Non-Sterile,<br>Tested for Use with<br>Chemotherapy Drugs is a<br>patient examination glove<br>is a disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested<br>for use with<br>Chemotherapy Drugs as<br>per ASTM D6978-05<br>(2019), Standard Practice<br>for Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | Same |

#### MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6,

DrivingInnovation. Protecting Lives.

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

Kawasan Industri Sungai Puloh,

42100 Klang, Selangor.

MALAYSIA

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Image /page/8/Picture/1 description: The image contains the logo for Mah Sing Healthcare. The words "Mah Sing" are in a large, red, stylized font. Below that, the word "HEALTHCARE" is in a smaller, black, sans-serif font. The logo is simple and professional.

# 9.0 Summary of Non-Clinical Testing

# Table 2 -Performance Testing

| Non-Clinical Testing | | | |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6124-06<br>(Reapproved 2017)<br>Standard Test Method for<br>Residual Powder on Medical<br>Gloves. | To determine the<br>residual powder in<br>the gloves | Less than 2mg / glove | Size XS 0.23mg/glove<br>Size S 0.20mg/glove<br>Size M 0.25mg/glove<br>Size L 0.25mg/glove<br>Size XL 0.30mg/glove |
| ASTM D5151-19<br>Standard Test Method for<br>Detection of Holes in<br>Medical Gloves. | To determine the<br>holes in the gloves | Inspection level, G-I<br>AQL 2.5<br>(In accordance with<br>ASTM D6319-19) | Passed G-I, AQL 1.5 |
| ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine the<br>length of the gloves | Size XS 220mm, min<br>Size S 220mm, min<br>Size M 230mm, min<br>Size L 230mm, min<br>Size XL 230mm, min | Size XS 244 - 247mm<br>Size S 243 - 248mm<br>Size M 243 - 252mm<br>Size L 243 - 249mm<br>Size XL 243 - 249mm |
| ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application. | To determine the<br>width of the gloves | Size XS 70 ± 10mm<br>Size S 80 ± 10mm<br>Size M 95 ± 10mm<br>Size L 110 ± 10mm<br>Size XL 120 ± 10mm | Size XS 76 - 78mm<br>Size S 81 - 88mm<br>Size M 95 - 99mm<br>Size L 102 - 111mm<br>Size XL 111 - 119mm |
| Non-Clinical Testing (Cont'd) | | | |
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine the<br>thickness of the<br>gloves | Measured in single wall at approximate center of palm area<br>Palm<br>0.05mm, min | Size XS<br>0.06 – 0.07mm<br>Size S<br>0.06 – 0.07mm<br>Size M<br>0.06 – 0.07mm<br>Size L<br>0.06 – 0.07mm<br>Size XL<br>0.06 – 0.07mm |
| | | Measured in single wall at 13±3mm from the tip of middle<br>finger<br>Finger<br>0.05mm, min | Size XS<br>0.07 – 0.08mm<br>Size S<br>0.07 – 0.08mm<br>Size M<br>0.07 – 0.08mm<br>Size L<br>0.07 – 0.08mm<br>Size XL<br>0.07 – 0.08mm |
| ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength<br>14MPa, min for all sizes | Size XS<br>23.79 MPa, average<br>Size S<br>24.89 MPa, average<br>Size M<br>25.39 MPa, average<br>Size L<br>26.44 MPa, average<br>Size XL<br>26.05 MPa, average |
| | | After Ageing<br>Tensile Strength<br>14MPa, min for all sizes | Size XS<br>27.52 MPa, average<br>Size S<br>26.28 MPa, average<br>Size M<br>25.93 MPa, average<br>Size L<br>26.21 MPa, average<br>Size XL<br>25.98 MPa, average |
| | To determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500%, min for all sizes | Size XS<br>539%, average<br>Size S<br>533%, average<br>Size M<br>527%, average<br>Size L<br>538%, average<br>Size XL<br>526%, average |
| | | After Ageing<br>Ultimate Elongation 400%,<br>min for all sizes | Size XS<br>435%, average<br>Size S<br>453%, average<br>Size M<br>460%, average<br>Size L<br>455%, average<br>Size XL<br>470%, average |
| Non-Clinical Testing (Cont'd) | | | |
| Test Method | Purpose | Acceptance<br>Criteria | Result |
| ASTM D6897-05<br>Standard Practice for<br>Assessment of Resistance<br>of Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | To provide a uniform<br>procedure for assessing the<br>resistance of medical glove<br>materials to permeation by<br>chemotherapy drugs, and<br>to establish a consistent<br>reporting of the test data. | >240<br>minutes | *Carmustine 3.3mg/ml = 32.2<br>Cisplatin 1 mg/ml = >240<br>Cyclophosphamide 20 mg/ml = >240<br>Dacarbazine 10 mg/ml = >240<br>Doxorubicin, HCl 2 mg/ml = >240<br>Etoposide 20 mg/ml = >240<br>Fluorouracil 50 mg/ml = >240<br>Methotrexate 25 mg/ml = >240<br>Mitomycin 0.5 mg/ml = >240<br>Oxaliplatin 5 mg/ml = >240<br>Paclitaxel 6 mg/ml = >240<br>*Thiotepa 10 mg/ml = 37.4<br>Vincristine 1 mg/ml = >240 |

# MAH SING HEALTHCARE SDN BHD

DrivingInnovation. Protecting Lives.

Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Mah Sing Healthcare. The words "Mah Sing" are in red, with "Mah" stacked on top of "Sing". Below that, the word "HEALTHCARE" is in black. The logo is simple and modern.

DrivingInnovation. Protecting Lives.

MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image contains the logo for Mah Sing Healthcare. The word "MahSing" is in red, and the word "Healthcare" is in black. The word "Healthcare" is directly below the word "MahSing".

| Biocompatibility Testing | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Test Method | Purpose | Acceptance Criteria | Result | | |
| ISO 10993-10<br>Biological evaluation of<br>medical devices - Part<br>10: Tests for irritation<br>and skin sensitization<br>(Animal Irritation<br>Test) | To determine the<br>potential of the<br>material under test to<br>produce dermal<br>irritation in Rabbits | Under the condition<br>of study not an<br>irritant. | There was no observable irreversible<br>alteration on the skin at the sites of contact<br>with the test material. The Primary<br>Irritation Index (PII) was "0". The test<br>material was not irritant and the<br>Primary Irritation Response Category is<br>therefore "negligible", thereof met the<br>requirement. | | |
| ISO 10993-10<br>Biological evaluation of<br>medical devices -<br>Part 10: Tests for<br>irritation and skin<br>sensitization<br>(Dermal Sensitization<br>Assay Test) | To determine the<br>skin sensitization<br>potential of the<br>material both in<br>terms of induction<br>and elicitation in<br>Guinea pig | Under the condition<br>of the study not a<br>sensitizer. | There was no sensitization induced by the<br>application of the test material on the<br>albino guinea pigs under the condition of<br>this test, thereof met the requirement. | | |
| ISO 10993-11<br>Biological evaluation of<br>medical devices - Part 11:<br>Tests for systemic toxicity<br>(Acute Systemic Toxicity) | To provide<br>information on<br>health hazards likely<br>to arise from a short-<br>term exposure to the<br>extracts of test<br>material by<br>intravenous and<br>intraperitoneal<br>injection in mice | Not induce acute<br>systemic toxicity | Under the condition of this study, the<br>single dose acute systemic toxicity of<br>extracts from test material using both<br>normal saline and sesame oil, did not<br>demonstrate any adverse toxic reaction,<br>thereof met the requirement. | | |

Non-clinical tests were carried out to demonstrate product performance conformity with the standards referenced.

DrivingInnovation. Protecting Lives.

MAH SING HEALTHCARE SDN BHD Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

T 603 3396 2288 F 603 3396 2299 mshealthcare.com

{11}------------------------------------------------

#### The following bench tests were performed:

#### Non-clinical tests

- Residual Powder Content -
- -Physical Properties
- -Physical Dimension
- -Freedom from Holes
- Chemotherapy Drug Permeation Test -

#### Biocompatibility Testing

- Animal Irritation Test -
- -Dermal Sensitization Assay
- -Acute Systemic Toxicity

The results from these performance evaluations demonstrated that the Nitrile Powder Free Black Patient Examination Gloves, Non-Sterile, Tested for Use With Chemotherapy Drugs met the acceptance criteria defined in standards referenced.

| 10.0 Summary of Clinical Testing | Clinical Testing is not needed for this device. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11.0 Conclusion | The conclusion drawn from the non-clinical test demonstrate<br>that the subject device is as safe, as effective, and performs as<br>well as or better than t…