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

• K Number: K230002
• Device Name: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
• Manufacturer: Mah Sing Healthcare Sdn Bhd
• Date Cleared: 2023-03-24 ( 80 days)
• Product Code: LZA LZC OPJ
• Regulation Number: 880.6250

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 Description

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. The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are black in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

Predicate Devices

K214110

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of the glove, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as a "patient examination glove" intended to prevent contamination between patient and examiner, and for protection against chemotherapy drugs. Its purpose is protective, not therapeutic or curative for a medical condition.

Diagnostic

No

Gloves are used to prevent contamination and protect the examiner, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made from acrylonitrile-butadiene copolymer dispersion, which is a hardware component. The performance studies also focus on physical properties and material testing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures.
• IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This glove does not perform any such analysis.
• Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic function.
• Performance Studies: The performance studies listed are related to the physical integrity, barrier properties (including chemotherapy drug permeation), and biocompatibility of the glove, not to any diagnostic accuracy or analytical performance.

The fact that the gloves are "Tested For Use With Chemotherapy Drugs" relates to their barrier function and safety for the user when handling these substances, not to any diagnostic capability.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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:

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

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, OPJ

Device Description

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.

The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are black in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or finger (worn on the examiner's hand or finger)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Medical purpose (worn on the examiner's hand)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K214110

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

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.

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 ([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

2

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)

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.gov

"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.

3

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 /
Contact details	Mah Sing Healthcare Sdn. Bhd
Lot 6478, Lorong Sungai Puloh/KU6,
Kawasan Industri Sungai Puloh,
Klang, Selangor 42100
MALAYSIA
	Contact Person Details:
Ivan Tan Chee Wei (Mr.)
E-mail: [e-mail]
Tel: [phone], Extn: 2213
Fax: [phone]
3.0 Summary
Preparation Date	February 20, 2023
4.0 Device Name &
Classification	Trade Name: Nitrile Powder Free Black Patient Examination Gloves
Non-sterile, Tested for use with Chemotherapy Drugs
	Common Name: Nitrile Powder Free Patient Examination Glove
	Classification Name: Patient Examination Gloves Specialty
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
The Legally Marketed
Device	Predicate Device Name: Nitrile Powder Free Blue Patient Examination
Gloves, Non-Sterile, Tested For Use With
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.

4

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,
Tested For Use With Chemotherapy Drugs meets all the requirements of
ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR
880.6250. | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------|--|--|
| | The gloves are made from acrylonitrile-butadiene copolymer dispersion.
Inner surface of gloves undergoes surface treatment process to produce a
smooth surface that assists the user in donning the gloves without using
any lubricant such as powder on the glove surface. These gloves are black
in color and are powder free. The gloves are ambidextrous i.e., can be worn
on right hand or left hand, single use disposable devices that come in five
sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile
strength meet ASTM D 6319-19. | | | | |
| 7.0 Indications for 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:
Test Chemotherapy Drugs are as follows: | | | | |
| | Test Chemotherapy | Concentration | Minimum Breakthrough | | |
| | Drugs | | Detection Time in
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
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
|-------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------|
| 510(k) Number | - | K230002 | K214110 | - |
| Manufacturer | - | Mah Sing Healthcare Sdn.
Bhd. | Mah Sing Healthcare Sdn.
Bhd. | Same |
| Name of device | - | Nitrile Powder Free
Black Patient
Examination Gloves,
Non-Sterile, Tested for
use with chemotherapy
drugs and | Nitrile Powder Free
Blue Patient
Examination Gloves,
Non-Sterile, Tested for
use with chemotherapy
drugs | Similar |
| Device Classification
Name/Regulation Number | Patient Examination
Glove,
21 CFR Part 880.6250 | Patient Examination
Glove,
21 CFR Part 880.6250 | Patient Examination
Glove,
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

6

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
Parameters | Standard | Proposed Device
(K230002) | Predicate device
(K214110) | Comparison
Analysis |
|--------------------------------------|---------------|-------------------------------------------|-------------------------------|--------------------------------------------------------------------------------|
| Chemotherapy Drug
Permeation Test | ASTM D6897-05 | | | |
| Test Chemotherapy
Drugs | Concentration | Minimum Breakthrough Detection Time (min) | | |
| *Carmustine | 3.3mg/ml | 32.2 | 24.8 | Similar
Below 240 minutes
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
device perform
additional
Chemotherapy drug
test |
| Mitomycin | 0.5 mg/ml | >240 | Not tested | Optional, Subject
device perform
additional
Chemotherapy drug
test |
| Oxaliplatin | 5 mg/ml | >240 | Not tested | Optional, Subject
device perform
additional
Chemotherapy drug
test |
| Paclitaxel | 6 mg/ml | >240 | >240 | Similar |
| *Thiotepa | 10 mg/ml | 37.4 | 38.4 | Similar
Below 240 minutes
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
Parameters | Standard | Proposed Device
(K230002) | Predicate device
(K214110) | Comparison
Analysis |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Length
XS: Min.220mm
S: Min.220mm
M: Min.230mm
L: Min.230mm
XL: Min. 230mm | ASTM D 6319-19 | XS: 244 - 247mm
S: 243 - 248mm
M: 243 - 252mm
L: 243 - 249mm
XL: 243 - 249mm | 245 - 255mm | Similar |
| Width
XS:60mm - 80mm
S: 70mm – 90mm
M: 85mm - 105mm
L: 100mm – 120mm
XL:110mm - 130mm | ASTM D 6319-19 | XS: 76 - 78mm
S: 81 - 88mm
M: 95 - 99mm
L: 102 - 111mm
XL: 111 - 119mm | S: 83 - 85mm
M: 93 - 96mm
L: 105 - 109mm
XL: 116 - 118mm | Similar |
| Palm Thickness
(Minimum 0.05mm) | ASTM D 6319-19 | 0.06 - 0.07mm | 0.06 - 0.07mm | Similar |
| Finger Thickness
(Minimum 0.05mm) | ASTM D 6319-19 | 0.07 - 0.08mm | 0.08 - 0.11mm | Similar |
| Tensile Strength
(Before aging) Minimum
14 MPa | ASTM D 6319-19 | Average: 25.31MPa | Average: 21.96MPa | Similar |
| Tensile Strength
(After accelerated aging)
Minimum 14 MPa | ASTM D 6319-19 | Average: 26.38MPa | Average: 28.30MPa | Similar |
| Ultimate Elongation
(before aging) Minimum
500% | ASTM D 6319-19 | Average: 533% | Average: 537% | Similar |
| Ultimate Elongation
(after accelerated aging)
Minimum 400% | ASTM D 6319-19 | Average: 455% | Average: 449% | Similar |
| Freedom of Holes Meet
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
(Less than 2mg/glove) | ASTM D 6124-06 | Average powder residue
for each size.
XS: 0.23mg/glove
S: 0.20mg/glove
M: 0.25mg/glove
L: 0.25mg/glove
XL: 0.30mg/glove | Average powder residue
for each size:
S: 0.32mg/glove
M: 0.28mg/glove
L: 0.32mg/glove
XL: 0.30mg/glove | Similar |
| Animal Irritation Test | ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
Sensitization | Passed.
Under the conditions of
study, not an irritant | Passed.
Under the conditions of
study, not an irritant | Same |
| Dermal Sensitization | ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
sensitization | Passed.
Under the conditions of
study, not a sensitizer | Passed.
Under the conditions of
study, not a sensitizer | Same |
| Acute Systemic Toxicity | ISO 10993-11
Biological evaluation
of medical devices -
Part 11: Tests for
systemic toxicity | Not induce acute systemic
toxicity | Not induce acute systemic
toxicity | Same |
| Characteristics and
Parameters | Standard | Proposed Device
(K230002) | Predicate device
(K214110) | Comparison
Analysis |
| Indication for use | - | Nitrile Powder Free Black
Patient Examination
Gloves, Non-Sterile,
Tested for Use with
Chemotherapy Drugs is 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. | Nitrile Powder Free Blue
Patient Examination
Gloves, Non-Sterile,
Tested for Use with
Chemotherapy Drugs is 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. | 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

8

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

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

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