Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical and chemical properties of a patient examination glove, with no mention of AI or ML technology.

Therapeutic

No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, not therapeutic.

Diagnostic

No

The device is a medical glove, a protective barrier and not used 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, and the performance studies focus on physical properties and chemical permeation, not software functionality.

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 clearly states the device is a "patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties and materials of the glove, its testing for chemotherapy drug and fentanyl permeation, and its classification as a Class I patient examination glove. This aligns with a protective barrier device.
Performance Studies: The performance studies focus on the physical integrity of the glove (holes, dimensions, tensile strength), its resistance to chemical permeation (chemotherapy drugs, fentanyl), and biocompatibility. These are tests relevant to a protective barrier device, not an IVD.
Key Metrics: The key metrics reported are related to the physical characteristics and barrier properties of the glove, not diagnostic performance metrics like sensitivity, specificity, etc., which are typical for IVDs.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide diagnostic information. This glove does not perform any such testing.

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	14.1
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	57.2
Vincristine 1 mg/ml	>240

Test Fentanyl Citrate are as follows:

Test Chemotherapy Drugs Concentration	Minimum Breakthrough Detection Time in minutes
Fentanyl Citrate Injection 100mcg/2ml	>240

Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 14.1 minutes (2)Thiotepa - 57.2 minutes.

Product codes

LZA, LZC, OPJ, QDO

Device Description

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

Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs are Class I patient examination gloves bear the product code Nitrile - LZA, LZC, OPJ and QDO (21CFR880.6250). 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 blue 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

worn on the examiner's hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 standards referenced.

Non-clinical tests performed:

Residual Powder Content:
- Test Method: ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.
- Purpose: To determine the residual powder in the gloves.
- Acceptance Criteria: Less than 2mg / glove.
- Result: Size XS 0.25mg /glove, Size S 0.20mg /glove, Size M 0.28mg /glove, Size L 0.28mg /glove, Size XL 0.38mg /glove.
Freedom from Holes:
- Test Method: ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
- Purpose: To determine the holes in the gloves.
- Acceptance Criteria: Inspection level, G-I, AQL 2.5 (In accordance with ASTM D6319-19).
- Result: Passed G-I, AQL 1.5.
Physical Dimension (Length):
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the length of the gloves.
- Acceptance Criteria: Size XS 220mm, min; Size S 220mm, min; Size M 230mm, min; Size L 230mm, min; Size XL 230mm, min.
- Result: Size XS 245 - 251mm; Size S 247 - 255mm; Size M 245 - 255mm; Size L 247 - 255mm; Size XL 247 - 252mm.
Physical Dimension (Width):
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the width of the gloves.
- Acceptance Criteria: Size XS 70 ± 10mm; Size S 80 ± 10mm; Size M 95 ± 10mm; Size L 110 ± 10mm; Size XL 120 ± 10mm.
- Result: Size XS 76 - 78mm; Size S 82 - 88mm; Size M 95 - 99mm; Size L 111 - 118mm; Size XL 120 - 127mm.
Thickness:
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the thickness of the gloves.
- Acceptance Criteria (Palm): 0.05mm, min.
- Result (Palm): Measured in single wall at approximate center of palm area; Size XS 0.06 - 0.06mm; Size S 0.06 - 0.07mm; Size M 0.06 - 0.07mm; Size L 0.06 - 0.06mm; Size XL 0.06 - 0.06mm.
- Acceptance Criteria (Finger): 0.05mm, min.
- Result (Finger): Measured in single wall at 13±3mm from the tip of middle finger; Size XS 0.07 — 0.07mm; Size S 0.07 - 0.08mm; Size M 0.07 - 0.08mm; Size L 0.07 - 0.08mm; Size XL 0.07 - 0.08mm.
Physical Properties (Tensile strength - Before Ageing):
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the physical properties - Tensile strength.
- Acceptance Criteria: 14Mpa, min for all sizes.
- Result: Size XS 23.97 MPa, average; Size S 26.35 MPa, average; Size M 25.15 MPa, average; Size L 25.11 MPa, average; Size XL 25.85 MPa, average.
Physical Properties (Tensile strength - After Ageing):
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the physical properties - Tensile strength.
- Acceptance Criteria: 14Mpa, min for all sizes.
- Result: Size XS 27.11 MPa, average; Size S 26.78 MPa, average; Size M 29.22 MPa, average; Size L 25.94 MPa, average; Size XL 26.50 MPa, average.
Physical Properties (Ultimate Elongation - Before Ageing):
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the physical properties - Ultimate Elongation.
- Acceptance Criteria: 500%, min for all sizes.
- Result: Size XS 571%, average; Size S 571%, average; Size M 538%, average; Size L 552%, average; Size XL 525%, average.
Physical Properties (Ultimate Elongation - After accelerated aging):
- Test Method: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Purpose: To determine the physical properties - Ultimate Elongation.
- Acceptance Criteria: 400%, min for all sizes.
- Result: Size XS 462%, average; Size S 458%, average; Size M 434%, average; Size L 457%, average; Size XL 434%, average.
Chemotherapy Drug Permeation Test:
- Test Method: ASTM D6897-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
- Purpose: 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.
- Acceptance Criteria: >240 minutes.
- Result: *Carmustine 3.3mg/ml = 4.1; 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 = 57.2; Vincristine 1 mg/ml = >240; Fentanyl Citrate Injection 100mcg/2ml = >240.
Biocompatibility Testing (Animal Irritation Test):
- Test Method: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- Purpose: To determine the potential of the material under test to produce dermal irritation in Rabbits.
- Acceptance Criteria: Under the condition of study not an irritant.
- Result: 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 corrosive, and the Primary Irritation Response Category is therefore "negligible", thereof met the requirement.
Biocompatibility Testing (Dermal Sensitization Assay Test):
- Test Method: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- Purpose: To determine the skin sensitization potential of the material both in terms of induction and elicitation in Guinea pig.
- Acceptance Criteria: Under the condition of the study not a sensitizer.
- Result: 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.
Biocompatibility Testing (Acute Systemic Toxicity):
- Test Method: ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- Purpose: 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.
- Acceptance Criteria: Not induce systemic toxicity.
- Result: Under the condition of this study, the single dose acute systemic toxicity of extracts from test material using both normal saline and sesame oil, shown non-toxic effects, thereof met the requirement.

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

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

Not Found

Predicate Device(s)

K192954

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.

February 2, 2023 Mah Sing Healthcare Sdn Bhd Ivan Tan Chee Wei Senior QA Manager Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, Kuala Lumpur 57100 Malaysia

Re: K223415

Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO

Dear Ivan Tan Chee Wei:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 01/27/23. Specifically, FDA is updating this SE Letter to correct the contact name to include the two middle names as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, OHT4: Office of Surgical and Infection Control Devices, at: 301-796-2261 or bifeng.gian@fda.hhs.gov.

Sincerely,

Bifeng Qian -S

Bifeng Qian, MD, 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

1

Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

January 26, 2023

Mah Sing Healthcare Sdn Bhd Ivan Wei Senior QA Manager Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, Kuala Lumpur 57100 Malaysia

Re: K223415

Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: November 1, 2022 Received: November 10, 2022

Dear Ivan 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 mav, 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.

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

2

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D. Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K223415

Device Name

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

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	14.1
Cisplatin1 mg/ml	>240
Cyclophosphamide 20 mg/ml	>240
Dacarbazine 10 mg/ml	>240
Doxorubicin, HCl2 mg/ml	>240
Etoposide20 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	57.2
Vincristine 1 mg/ml	>240
Test Fentanyl Citrate are as follows:

Test Chemotherapy Drugs Concentration Fentanyl Citrate Injection 100mcg/2ml

Minimum Breakthrough Detection Time in minutes >240

Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 14.1 minutes (2)Thiotepa - 57.2 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.

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Image /page/5/Picture/0 description: The image contains the logo for MahSing Healthcare. The word "MahSing" is in a large, bold, red font. Below that, the word "HEALTHCARE" is in a smaller, black, sans-serif font. The logo is simple and clean, with a focus on the company name.

Premarket Notification [510(k)] No: K223415

510 (K) SUMMARY
1.0 Device Name	Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile,
Tested For Use With Chemotherapy Drugs and Fentanyl Citrate.
2.0 Submitter name /
Contact details	Mah Sing Healthcare Sdn. Bhd
Wisma Mah Sing, Penthouse Suite 1,
163 Jalan Sungai Besi,
Kuala Lumpur
57100
MALAYSIA
	Contact Person Details:
Ivan Tan Chee Wei (Mr)
E-mail: ivan.tan@mshealthcare.com
Tel: +60-3-3396 2288, Extn: 2213
Fax: +60-3-3396 2299
3.0 Summary
Preparation Date	January 18, 2023
4.0 Device Name &
Classification	Trade Name: Nitrile Powder Free Blue Patient Examination Gloves
Non-sterile, Tested for use with Chemotherapy Drugs
and Fentanyl Citrate.
	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: LZC, LZA, OPJ, QDO
5.0 Identification of
The Legally Marketed
Device	Predicate Device Name: Blue Colored, Powder Free Nitrile Examination
Gloves, Non-sterile, and Tested for Use
With Chemotherapy Drugs and Fentanyl Citrate
	Predicate 510(K) Number: K192954
	Manufacture's Name: Comfort Rubber Gloves Industries Sdn Bhd.
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 word "Healthcare" in black underneath. The font is sans-serif and bolded.

| 6.0 Description of Device | Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested
For Use With Chemotherapy Drugs and Fentanyl Citrate meets all the
requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA
21 CFR 880.6250. | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------|--|
| | Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested
For Use With Chemotherapy Drugs are Class I patient examination gloves
bear the product code Nitrile - LZA, LZC, OPJ and QDO (21CFR880.6250).
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 blue
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 | 14.1 | |
| | 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 | 57.2 | |
| | Vincristine | 1 mg/ml | >240 | |
| | Test Fentanyl Citrate are as follows:
Test Chemotherapy Drugs | Concentration | Minimum Breakthrough | |
| | | | Detection Time in minutes | |
| | Fentanyl Citrate Injection | 100mcg/2ml | >240 | |
| | Warning: Do not use with Carmustine and Thiotepa. | | | |
| | *Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 14.1 minutes
(2) Thiotepa - 57.2 minutes. | | | |
| ovation. 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 | |

DrivingInn

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

8.0 Summary of the Technological Characteristic of the Device

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

| 1

able	1
-----------	---

| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 510(k) Number | - | K223415 | K192954 | Different |
| Manufacturer | - | Mah Sing Healthcare Sdn.
Bhd. | Comfort Rubber Gloves
Industries Sdn Bhd | Different |
| Name of device | - | Nitrile Powder Free Blue
Patient Examination
Gloves, Non-Sterile,
Tested for use with
chemotherapy drugs and
fentanyl citrate | Blue Colored, Powder
Free Nitrile Examination
Gloves, Non-Sterile, and
Tested for use with
chemotherapy drugs and
fentanyl citrate | 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, QDO | LZA, LZC, QDO | Same |
| Classification | - | Class 1 | Class 1 | Same |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
| Chemotherapy Drug
Permeation Test | ASTM D6897-05 | | | |
| Test Chemotherapy
Drugs | Concentration | Minimum Breakthrough Detection Time (min) | | |
| *Carmustine | 3.3mg/ml | 14.1 | 18.2 | 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 | 57.2 | 57.3 | Similar
Below 240 minutes
permeation times |
| Vincristine | 1 mg/ml | >240 | >240 | Similar |
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 | >240 | Similar |
| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
| Length
XS: Min. 220mm
S: Min.220mm
M: Min.230mm
L: Min.230mm
XL: Min.230mm | ASTM D 6319-19 | XS: 245 -251mm
S: 247 - 255mm
M: 245 - 255mm
L: 247 - 255mm
XL: 247- 252mm | Min. 240 mm | 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: 82 - 88mm
M: 95 - 99mm
L: 111 - 118mm
XL: 120 - 127mm | Not stated by predicate
device | Similar, subject
device meet
requirements
of ASTM
D6319 |
| Palm Thickness
(Minimum 0.05mm) | ASTM D 6319-19 | Average: 0.06mm | Min 0.05 | Similar |
| Finger Thickness
(Minimum 0.05mm) | ASTM D 6319-19 | Average: 0.07mm | Min 0.05 | Similar |
| Tensile Strength
(Before aging) Minimum
14 MPa | ASTM D 6319-19 | Average: 25.29MPa | Meets | Similar |
| Tensile Strength
(After accelerated aging)
Minimum 14 MPa | ASTM D 6319-19 | Average: 27.11MPa | Meets | Similar |
| Ultimate Elongation
(before aging) Minimum
500% | ASTM D 6319-19 | Average: 551% | Meets | Similar |
| Ultimate Elongation
(after accelerated aging)
Minimum 400% | ASTM D 6319-19 | Average: 449% | Meets | Similar |
| Freedom of Holes Meet
AQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 1.5 with G1 | Passes | Similar |
| Residual powder test
(Less than 2mg/glove) | ASTM D 6124-06 | Average powder residue
for each size.
XS: 0.25mg/glove
S: 0.20mg/glove
M: 0.28mg/glove
L: 0.28mg/glove
XL: 0.38mg/glove | Meets | 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 | Passes
Under the conditions of
the study, the subject
device is non-irritating | Similar |
| 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 | Passes
Under the conditions of
the study, the subject
device is non-sensitization | Similar |
| Acute Systemic Toxicity | ISO 10993-11
Biological evaluation
of medical devices -
Part 11: Tests for
systemic toxicity | Not induce acute systemic
toxicity | Passes
Under the conditions of
the study, the subject
showed no adverse
biological reaction | Similar |
| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
| Indication for use | - | Nitrile Powder Free Blue
Patient Examination
Gloves, Non-Sterile,
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate 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. | Blue Colored, Powder
Free Nitrile Examination
Gloves, Non-sterile, and
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate is a
specialty medical glove
which is a disposable
device intended for
medical purpose that is
worn on the examiner's
hand or finger to prevent
contamination between
examiner and patient. The
glove was tested for use
with Chemotherapy Drugs
and Fentanyl Citrate as per
ASTM D6978-05
Standard Practice for
Assessment of Medical
Gloves to Permeation by
Chemotherapy Drugs. | Same intended
use |

Driving Innovation. Protecting Lives.

mah sing healthcare sdn bhd Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

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8

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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

9

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Lot 6478, Lorong Sungai Puloh / KU6,

Kawasan Industri Sungai Puloh,

42100 Klang, Selangor.

MALAYSIA

F 603 3396 2299 mshealthcare.com

Driving Innovation. Protecting Lives.

10

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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 0.25mg /glove
Size S 0.20mg /glove
Size M 0.28mg /glove
Size L 0.28mg /glove
Size XL 0.38mg /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 245 - 251mm
Size S 247 - 255mm
Size M 245 - 255mm
Size L 247 - 255mm
Size XL 247 - 252mm
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 82 - 88mm
Size M 95 - 99mm
Size L 111 - 118mm
Size XL 120 - 127mm
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	Palm
0.05mm, min	Measured in single wall at approximate center of palm area
Size XS 0.06 - 0.06mm
Size S 0.06 - 0.07mm
Size M 0.06 - 0.07mm
Size L 0.06 - 0.06mm
Size XL 0.06 - 0.06mm
		Finger
0.05mm, min	Measured in single wall at 13±3mm from the tip of middle finger
Size XS 0.07 — 0.07mm
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 23.97 MPa, average
Size S 26.35 MPa, average
Size M 25.15 MPa, average
Size L 25.11 MPa, average
Size XL 25.85 MPa, average
		After Ageing
Tensile Strength
14Mpa, min for all sizes	Size XS 27.11 MPa, average
Size S 26.78 MPa, average
Size M 29.22 MPa, average
Size L 25.94 MPa, average
Size XL 26.50 MPa, average
	To determine the
physical properties-
Ultimate Elongation	Before Ageing
Ultimate Elongation
500%, min for all sizes	Size XS 571%, average
Size S 571%, average
Size M 538%, average
Size L 552%, average
Size XL 525%, average
		After Ageing
Ultimate Elongation 400%,
min for all sizes	Size XS 462%, average
Size S 458%, average
Size M 434%, average
Size L 457%, average
Size XL 434%, 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 = 4.1
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 = 57.2
Vincristine 1 mg/ml = >240
Fentanyl Citrate Injection 100mcg/2ml = >240

MAH SING HEALTHCARE SDN BHD

DrivingInnovation. Protecting Lives.

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

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DrivingInnovation. Protecting Lives.

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

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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 corrosive, 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
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, shown non-
toxic effects, thereof met the requirement.

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

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mah sing healthcare sdn bhd Lot 6478, Lorong Sungai Puloh / KU6, Kawasan Industri Sungai Puloh, 42100 Klang, Selangor. MALAYSIA

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Attachment 1 Additional Information Page 9 of 9

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 Blue Patient Examination Gloves, Non-Sterile, Tested for Use With Chemotherapy Drugs and Fentanyl Citrate 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
K192954.

DrivingInnovation. Protecting Lives.

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

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