Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the description focuses on its material properties and testing against ASTM standards, with no mention of AI or ML.

Therapeutic

No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.

Diagnostic

No

This device is a medical glove, a barrier device intended to prevent contamination between patient and examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical medical device (gloves) and the description focuses on material properties, manufacturing processes, and physical performance testing, not software functionality.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
Intended Use: The intended use of this device is clearly stated as a "powder-free patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used on the body (or on the examiner's hand) for protection, not for testing samples from the body.
Device Description: The description focuses on the physical properties and manufacturing process of the glove, not on any diagnostic testing capabilities.
Performance Studies: The performance studies described relate to the physical integrity of the glove (dimensions, physical properties, water tightness) and its resistance to chemotherapy drugs, not to the accuracy or reliability of a diagnostic test.
Key Metrics: The key metric mentioned is "Minimum Breakthrough Detection Time in Minutes for various chemotherapy drugs," which is a measure of the glove's barrier performance, not a diagnostic metric like sensitivity or specificity.

The fact that the gloves are tested for use with chemotherapy drugs relates to their protective function as a barrier, not to any diagnostic capability.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KS Medicare Powder Free Examination Gloves. Non-sterile. Tested for use with Chemotherapy Drugs (Black): A powder-free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

KS Medicare Powder Free Examination Gloves. Non-sterile. Tested for use with Chemotherapy Drugs (Blue): A powder-free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

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

LZA, LZC

Device Description

KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, meeting all the requirement of ASTM standards D6319-10 (Reapproved 2015), ASTM D6978-05 and ASTM D6124-06 (Reaffirmation 2011). Principle of operation: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. This powder free nitrile examination glove is manufactured from synthetic rubber. A process known as chlorination has been incorporated in the manufacturing of the gloves that don easily for the user without the addition of powder. Chlorination is a process wherein examination gloves are exposed to chlorine gas or a hypochloritehydrochloric acid mixture in order to harden the surface of the glove. The hardening of the glove surface decreases the surface friction of the glove thereby allowing for gloves to be easily donned without powder. The gloves are ambidextrous and offered in three sizes: small, medium, and large.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or finger (of the examiner)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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)

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements). The device and the predicate share the same intended use, same material, same compliance with standards for dimension, physical properties, powder free, biocompatibility, water tightness and tested using ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. It was our conclusion that KS Medicare Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs tested met all relevant requirements of the aforementioned tests. No clinical data is required.

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.

K161422

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). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 22, 2018

Koon Seng Sdn. Bhd. % Jigar Shah Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck. New York 11021

Re: K171171

Trade/Device Name: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: January 10, 2018 Received: January 11, 2018

Dear Jigar Shah:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171171

Device Name

KS Medicare Powder Free Examination Gloves, Non-sterile, Tested for use with Chemotherapy Drugs (Black)

Indications for Use (Describe)

A powder-free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

Test Chemotherapy Drug and Concentration	Minimum Breakthrough Detection time in Minutes
1. Carmustine (BCNU), 3.3 mg/ml	22.6
2. Cisplatin, 1.0 mg/ml	≥ 240
3. Cyclophosphamide (Cytoxan), 20.0 mg/ml	≥ 240
4. Dacarbazine (DTIC), 10.0 mg/ml	≥ 240
5. Doxorubicin Hydrochloride, 2.0 mg/ml	≥ 240
6. Etoposide (Toposar), 20.0 mg/ml	≥ 240
7. Fluorouracil, 50.0 mg/ml	≥ 240
8. Methotrexate, 25 mg/ml	≥ 240
9. Paclitaxel (Taxol), 6.0 mg/ml	≥ 240
10. Thiotepa, 10.0 mg/ml	14.0

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 22.6 minutes Thiotepa, 10.0 mg/ml 14.0 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."

FORM FDA 3881 (8/14)

3

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171171

Device Name

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for use with Chemotherapy Drugs (Blue)

Indications for Use (Describe)

A powder-free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

Test Chemotherapy Drug and Concentration	Minimum Breakthrough Detection Time in Minutes
1. Carmustine (BCNU), 3.3 mg/ml	14.8
2. Cisplatin, 1.0 mg/ml	≥ 240
3. Cyclophosphamide (Cytoxan), 20.0 mg/ml	≥ 240
4. Dacarbazine (DTIC), 10.0 mg/ml	≥ 240
5. Doxorubicin Hydrochloride, 2.0 mg/ml	≥ 240
6. Etoposide (Toposar), 20.0 mg/ml	≥ 240
7. Fluorouracil, 50.0 mg/ml	≥ 240
8. Methotrexate, 25 mg/ml	≥ 240
9. Paclitaxel (Taxol), 6.0 mg/ml	≥ 240
10. Thiotepa, 10.0 mg/ml	35.2

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 14.8 minutes Thiotepa, 10.0 mg/ml 35.2 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.

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."

FORM FDA 3881 (8/14)

4

510(k) SUMMARY

The assigned 510(k) number is: K171171

1. Submitter's Identification:

Applicant:

Name: Koon Seng Sdn. Bhd. Address: PTD 16058, Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia

Submitter:

Mr. Jigar Shah Name: Official Correspondent for Koon Seng Sdn. Bhd. Address: mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Date Summary Prepared: January 9,

2018 Contact: Mr. Jiqar Shah 516-482-9001 Office: Fax: 516-482-0186 jigar@mdiconsultants.com Email:

2. Name of the Device:

Device Name: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested For Use with Chemotherapy Drugs (Blue, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC

3. Information for the 510(k) Cleared Device (Predicate Device):

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs previously cleared under 510(k) K161422 (product code LZA, LZC)

4. Device Description:

KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, meeting all the requirement of ASTM standards D6319-10 (Reapproved 2015), ASTM D6978-05 and ASTM D6124-06 (Reaffirmation 2011).

Principle of operation: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of

5

examiners to prevent contamination between the patient and examiner. This powder free nitrile examination glove is manufactured from synthetic rubber. A process known as chlorination has been incorporated in the manufacturing of the gloves that don easily for the user without the addition of powder. Chlorination is a process wherein examination gloves are exposed to chlorine gas or a hypochloritehydrochloric acid mixture in order to harden the surface of the glove. The hardening of the glove surface decreases the surface friction of the glove thereby allowing for gloves to be easily donned without powder.

The gloves are ambidextrous and offered in three sizes: small, medium, and large. Attached please refer to following:

1. Device Drawing
1. Device Photos (Black and Blue)
1. Device Specifications (Black and Blue)

5. Indications for Use:

KS Medicare Powder Free Examination Gloves. Non-sterile. Tested for use with Chemotherapy Drugs (Black):

A powder-free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| | Test Chemotherapy Drug and
Concentration | Minimum
Breakthrough
Detection
Time in
Minutes |
|----|---------------------------------------------|------------------------------------------------------------|
| 1. | Carmustine (BCNU), 3.3 mg/ml | 22.6 |
| 2. | Cisplatin, 1.0 mg/ml | ≥ 240 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 7. | Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 8. | Methotrexate, 25 mg/ml | ≥ 240 |
| 9. | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| 10 | Thiotepa, 10.0 mg/ml | 14.0 |

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

Carmustine (BCNU), 3.3 mg/ml	22.6 minutes
Thiotepa, 10.0 mg/ml	14.0 minutes

6

KS Medicare Powder Free Examination Gloves. Non-sterile. Tested for use with Chemotherapy Drugs (Blue):

A powder-free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| | Test Chemotherapy Drug and
Concentration | Minimum
Breakthrough
Detection
Time in
Minutes |
|----|---------------------------------------------|------------------------------------------------------------|
| 1. | Carmustine (BCNU), 3.3 mg/ml | 14.8 |
| 2. | Cisplatin, 1.0 mg/ml | ≥ 240 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 7. | Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 8. | Methotrexate, 25 mg/ml | ≥ 240 |
| 9. | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| 10 | Thiotepa, 10.0 mg/ml | 35.2 |
| | | |

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

Carmustine (BCNU), 3.3 mg/ml	14.8 minutes
Thiotepa, 10.0 mg/ml	35.2 minutes

6. Comparison to the 510(k) Cleared Devices (Predicate Devices):

Table 1: Proposed Device (Blue) compares Predicate Device

Device Characteristic	Proposed Device	Predicate Device	Comparison
Product Name	KS Medicare Powder -Free
Nitrile Examination Gloves
Tested for Use with
Chemotherapy Drugs	Dermagrip Powder Free Blue
Nitrile Examination Gloves,
Non-sterile, Tested for use
with Chemotherapy Drugs
510(K) Reference	K171171	K161422
Product Owner	Koon Seng Sdn. Bhd.	WRP Asia Pacific Sdn. Bhd.
Product Code	LZA, LZC	LZA, LZC	Same

7

Device Characteristic	Proposed Device	Predicate Device	Comparison
Indication For Use	A powder-free 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.

8

Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile	Same
Single Use vs.	Single Use	Single Use	Same
Tested for Use with
Chemotherapy Drugs	Meets ASTM D6978-05	Meets ASTM D6978-05	Same

Table 3: Proposed Device (Blue) Compares Predicate Device

Device Characteristic	Proposed Device	Predicate Device	Comparison

Chemotherapy Drugs
Tested	Breakthrough Detection Time in Minutes
Fluorouracil (Adrucil)
– 50.0 mg/ml	≥ 240	≥ 240	Similar
Etopside (Toposar)
– 20.0 mg/ml	≥ 240	≥ 240
Cyclophosphamide
(Cytoxan)
– 20.0 mg/ml	≥ 240	≥ 240
Carmustine (BCNU)
– 3.3 mg/ml	14.8	15.0
Thiotepa
– 10.0 mg/ml	35.2	2.0
Paclitaxel (Taxol)
– 6.0 mg/ml	≥ 240	≥ 240
Doxorubicin
Hydrochloride
(Adriamycin)
– 2.0 mg/ml	≥ 240	≥ 240
Dacarbazine
– 10.0 mg/ml	≥ 240	≥ 240
Cisplatin
– 1.0 mg/ml	≥ 240	≥ 240
I fosfamide
– 50.0 mg/ml	-	≥ 240
Mitoxantrone
– 2.0 mg/ml	-	≥ 240
Vincristine Sulfate
– 1.0 mg/ml	-	≥ 240
Methotrexate
– 25 mg/ml	≥ 240	≥ 240
Mitomycin C
– 0.5 mg/ml	-	≥ 240

9

Table 4: Proposed Device (Black) compares Predicate Device

Device Characteristic	Proposed Device	Predicate Device	Comparison
Product Name	KS Medicare Powder -Free
Nitrile Examination Gloves
Tested for Use with
Chemotherapy Drugs	Dermagrip Powder Free Blue
Nitrile Examination Gloves,
Non-sterile, Tested for use
with Chemotherapy Drugs
510(K) Reference		K161422
Product Owner	Koon Seng Sdn. Bhd.	WRP Asia Pacific Sdn. Bhd.
Product Code	LZA, LZC	LZA, LZC	Same

Table 5: Proposed Device (Black) Compares Predicate Device

Device Characteristic	Proposed Device	Predicate Device	Comparison
Intended Use	Worn on the hand for
medical purposes to provide
a barrier
against potential infections
and other contaminants. In
addition
these gloves are worn to	Worn on the hand for medical
purposes to provide a barrier
against potential infections and
other contaminants. In addition
these gloves are worn to protect
wearer against exposure to
chemotherapy drugs	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Material	Nitrile	Nitrile	Same
Color	Black	Blue	Different
Design Configuration	Ambidextrous; Inner Glove
Surface Chlorine Treated to
facilitate Donning; Fingertips
Textured to Improve Tactility
and Grip	Inner surface of gloves
undergoes surface treatment
process to produce a smooth
surface that assists the user in
donning the gloves with ease
without using any lubricant such
as powder on the glove surface.
The glove is ambidextrous.	Similar
Dimensions - Length	Meets ASTM D6319-10
Min.: 230mm	Meets ASTM D6319-10
Min.: 240mm	Similar
Dimensions - Width	Meets ASTM D6319-10	Meets ASTM D6319-10	Same
Dimensions-Thickness	Meets ASTM D6319-10
Finger: Min. 0.08mm
Palm: Min. 0.07mm	Meets ASTM D6319-10
Finger: 0.07 – 0.10mm
Palm: 0.07 - 0.09mm	Similar
Physical Properties -
Tensile	Meets ASTM D6319-10	Meets ASTM D6319-10	Same
Physical Properties -
Elongation	Meets ASTM D6319-10	Meets ASTM D6319-10	Same
Freedom from Holes	Meets ASTM D5151-06
and	Meets ASTM D5151-06 and
21CFR 800.20	Same
Residual Powder	Meets Powder level
requirements for "Powder
Free" per ASTM D6319-10
tested using ASTM
D6124-06	Meets Powder level
requirements for "Powder
Free" per ASTM D6319-10
tested using ASTM
D6124-06	Same
Biocompatibility	Passes tests for:
-Primary Skin Irritation
-Dermal Sensitization	Passes tests for:
-Primary Skin Irritation
-Dermal Sensitization	Same
Prescription vs. OTC	OTC	OTC	Same

10

Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile	Same
Single Use vs. Reusable	Single Use	Single Use	Same
Tested for Use with
Chemotherapy Drugs	Meets ASTM D6978-05	Meets ASTM D6978-05	Same

Table 6: Proposed Device (Black) Compares Predicate Device

Device Characteristic	Proposed Device	Predicate Device	Comparison

Chemotherapy Drugs
Tested	Breakthrough Detection Time in Minutes
Fluorouracil (Adrucil)
– 50.0 mg/ml	≥ 240	≥ 240	Similar
Etopside (Toposar)
– 20.0 mg/ml	≥ 240	≥ 240
Cyclophosphamide
(Cytoxan)
– 20.0 mg/ml	≥ 240	≥ 240
Carmustine (BCNU)
– 3.3 mg/ml	22.6	15.0
Thiotepa
– 10.0 mg/ml	14.0	2.0
Paclitaxel (Taxol)
– 6.0 mg/ml	≥ 240	≥ 240
Doxorubicin
Hydrochloride
(Adriamycin)
– 2.0 mg/ml	≥ 240	≥ 240
Dacarbazine
– 10.0 mg/ml	≥ 240	≥ 240
Cisplatin
– 1.0 mg/ml	≥ 240	≥ 240
I fosfamide
– 50.0 mg/ml	-	≥ 240
Mitoxantrone
– 2.0 mg/ml	-	≥ 240
Vincristine Sulfate
– 1.0 mg/ml	-	≥ 240
Methotrexate
– 25 mg/ml	≥ 240	≥ 240
Mitomycin C
– 0.5 mg/ml	-	≥ 240

Summary of Technological to Predicate Device – The subject device differs from the predicate:

Difference in Colorant: Koon Seng Sdn. Bhd. medical grade colorant into the subject

11

device. The subject device has been tested and shown to function as an effective barrier to chemotherapeutic agents. The subject device has also passed biocompatibility tests for skin irritation and dermal sensitization; the subject gloves are non-toxic and may safely contact either users or patients.

1. Discussion of Non-Clinical Test:

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).

The device and the predicate share the same intended use, same material, same compliance with standards for dimension, physical properties, powder free, biocompatibility, water tightness and tested using ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

It was our conclusion that KS Medicare Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs tested met all relevant requirements of the aforementioned tests.

2. Discussion of Clinical Tests Performed:

No clinical data is required.

3. Conclusions:

KS Medicare Powder- Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Black)" produced by Koon Seng Sdn. Bhd. are as safe and as effective as the predicate device.