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

K171171 · Koon Seng Sdn Bhd · LZA · Feb 22, 2018 · General Hospital

Device Facts

• Record ID: K171171
• Device Name: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
• Applicant: Koon Seng Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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. 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.

Device Story

KS Medicare Powder-Free Nitrile Examination Gloves are non-sterile, single-use, ambidextrous disposable gloves manufactured from synthetic rubber. The manufacturing process incorporates chlorination to harden the surface, reducing friction for easier donning without powder. The gloves are available in blue and black and feature textured fingertips for improved tactility and grip. They are intended for use by healthcare examiners to provide a barrier against contamination between the patient and the examiner, and to protect the wearer from exposure to chemotherapy drugs. The device is used in clinical settings. Performance is verified through permeation testing against specific chemotherapy agents per ASTM D6978-05. The gloves provide a physical barrier; they do not involve electronic processing, software, or clinical decision-making algorithms.

Clinical Evidence

No clinical data required. Substantial equivalence is supported by bench testing, including physical property testing (tensile, elongation), freedom from holes, residual powder levels, biocompatibility (skin irritation, sensitization), and chemotherapy drug permeation testing per ASTM D6978-05.

Technological Characteristics

Material: Nitrile synthetic rubber. Design: Ambidextrous, chlorinated surface, textured fingertips. Standards: ASTM D6319-10 (dimensions, physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D6124-06 (powder-free), ASTM D5151-06 (freedom from holes). Sterilization: Non-sterile. Connectivity: None.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner, including protection against exposure to chemotherapy drugs.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs (K161422)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). 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

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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 ([e-mail]) or phone [phone] 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

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 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)

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 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)

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# 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: [phone] [e-mail] 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

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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
- 2. Device Photos (Black and Blue)
- 3. 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<br>Concentration | Minimum<br>Breakthrough<br>Detection<br>Time in<br>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 |

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## 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<br>Concentration | Minimum<br>Breakthrough<br>Detection<br>Time in<br>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<br>Nitrile Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs | Dermagrip Powder Free Blue<br>Nitrile Examination Gloves,<br>Non-sterile, Tested for use<br>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 |

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| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication For Use | A powder-free patient<br>examination glove is<br>a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br><br>In addition, these gloves<br>were tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard<br>Practice for Assessment<br>of Medical gloves to | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is<br>worn on the examiner's hand o<br>finger to prevent<br>contamination between patient<br>and examiner. These gloves<br>were tested for use with<br>Chemotherapy Drugs as per<br>ASTM D6978-05<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs:<br>Chemotherapy Drug<br>Permeation The following | Same |
| | Permeation by<br>Chemotherapy Drugs: | chemicals have been tested<br>with these gloves: | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Configuration | Ambidextrous; Inner Glove<br>Surface Chlorine Treated to<br>facilitate Donning; Fingertips<br>Textured to Improve Tactility<br>and Grip | Inner surface of gloves undergoes<br>surface treatment process to produce<br>a smooth surface that assists the<br>user in donning the gloves with ease<br>without using any lubricant such as<br>powder on the glove surface. The<br>glove is ambidextrous | Similar |
| Dimensions - Length | Meets ASTM D6319-10<br>Min.: 230mm | Meets ASTM D6319-10<br>Min.: 240mm | Similar |
| Dimensions - Width | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Dimensions-Thickness | Meets ASTM D6319-10<br>Finger: Min. 0.08mm<br>Palm: Min. 0.07mm | Meets ASTM D6319-10<br>Finger: 0.07 -<br>0.10mm Palm: 0.07 – | Similar |
| Physical Properties -<br>Tensile | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Physical Properties -<br>Elongation | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Freedom from Holes | Meets ASTM D5151-06<br>and 21CFR 800.20 | Meets ASTM D5151-06<br>and 21CFR 800.20 | Same |
| Residual Powder | Meets Powder level<br>requirements for "Powder<br>Free" per ASTM D6319-10<br>tested using ASTM<br>D6124-06 | Meets Powder level requirements<br>for "Powder Free" per ASTM<br>D6319-10 tested using<br>ASTM D6124-06 | Same |
| Biocompatibility | Passes tests for:<br>-Primary Skin Irritation<br>-Dermal Sensitization | Passes tests for:<br>-Primary Skin Irritation<br>-Dermal Sensitization | Same |
| Prescription vs. OTC | OTC | OTC | Same |

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| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
|-------------------------------------------|---------------------|---------------------|------|
| Single Use vs. | Single Use | Single Use | Same |
| Tested for Use with<br>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<br>Tested | Breakthrough Detection Time in Minutes | | |
| Fluorouracil (Adrucil)<br>– 50.0 mg/ml | ≥ 240 | ≥ 240 | Similar |
| Etopside (Toposar)<br>– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cyclophosphamide<br>(Cytoxan)<br>– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Carmustine (BCNU)<br>– 3.3 mg/ml | 14.8 | 15.0 | |
| Thiotepa<br>– 10.0 mg/ml | 35.2 | 2.0 | |
| Paclitaxel (Taxol)<br>– 6.0 mg/ml | ≥ 240 | ≥ 240 | |
| Doxorubicin<br>Hydrochloride<br>(Adriamycin)<br>– 2.0 mg/ml | ≥ 240 | ≥ 240 | |
| Dacarbazine<br>– 10.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cisplatin<br>– 1.0 mg/ml | ≥ 240 | ≥ 240 | |
| I fosfamide<br>– 50.0 mg/ml | - | ≥ 240 | |
| Mitoxantrone<br>– 2.0 mg/ml | - | ≥ 240 | |
| Vincristine Sulfate<br>– 1.0 mg/ml | - | ≥ 240 | |
| Methotrexate<br>– 25 mg/ml | ≥ 240 | ≥ 240 | |
| Mitomycin C<br>– 0.5 mg/ml | - | ≥ 240 | |

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## Table 4: Proposed Device (Black) compares Predicate Device

| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|-----------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------|
| Product Name | KS Medicare Powder -Free<br>Nitrile Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs | Dermagrip Powder Free Blue<br>Nitrile Examination Gloves,<br>Non-sterile, Tested for use<br>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<br>medical purposes to provide<br>a barrier<br>against potential infections<br>and other contaminants. In<br>addition<br>these gloves are worn to | Worn on the hand for medical<br>purposes to provide a barrier<br>against potential infections and<br>other contaminants. In addition<br>these gloves are worn to protect<br>wearer against exposure to<br>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<br>Surface Chlorine Treated to<br>facilitate Donning; Fingertips<br>Textured to Improve Tactility<br>and Grip | Inner surface of gloves<br>undergoes surface treatment<br>process to produce a smooth<br>surface that assists the user in<br>donning the gloves with ease<br>without using any lubricant such<br>as powder on the glove surface.<br>The glove is ambidextrous. | Similar |
| Dimensions - Length | Meets ASTM D6319-10<br>Min.: 230mm | Meets ASTM D6319-10<br>Min.: 240mm | Similar |
| Dimensions - Width | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Dimensions-Thickness | Meets ASTM D6319-10<br>Finger: Min. 0.08mm<br>Palm: Min. 0.07mm | Meets ASTM D6319-10<br>Finger: 0.07 – 0.10mm<br>Palm: 0.07 - 0.09mm | Similar |
| Physical Properties -<br>Tensile | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Physical Properties -<br>Elongation | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Freedom from Holes | Meets ASTM D5151-06<br>and | Meets ASTM D5151-06 and<br>21CFR 800.20 | Same |
| Residual Powder | Meets Powder level<br>requirements for "Powder<br>Free" per ASTM D6319-10<br>tested using ASTM<br>D6124-06 | Meets Powder level<br>requirements for "Powder<br>Free" per ASTM D6319-10<br>tested using ASTM<br>D6124-06 | Same |
| Biocompatibility | Passes tests for:<br>-Primary Skin Irritation<br>-Dermal Sensitization | Passes tests for:<br>-Primary Skin Irritation<br>-Dermal Sensitization | Same |
| Prescription vs. OTC | OTC | OTC | Same |

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| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
|-------------------------------------------|---------------------|---------------------|------|
| Single Use vs. Reusable | Single Use | Single Use | Same |
| Tested for Use with<br>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<br>Tested | Breakthrough Detection Time in Minutes | | |
| Fluorouracil (Adrucil)<br>– 50.0 mg/ml | ≥ 240 | ≥ 240 | Similar |
| Etopside (Toposar)<br>– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cyclophosphamide<br>(Cytoxan)<br>– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Carmustine (BCNU)<br>– 3.3 mg/ml | 22.6 | 15.0 | |
| Thiotepa<br>– 10.0 mg/ml | 14.0 | 2.0 | |
| Paclitaxel (Taxol)<br>– 6.0 mg/ml | ≥ 240 | ≥ 240 | |
| Doxorubicin<br>Hydrochloride<br>(Adriamycin)<br>– 2.0 mg/ml | ≥ 240 | ≥ 240 | |
| Dacarbazine<br>– 10.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cisplatin<br>– 1.0 mg/ml | ≥ 240 | ≥ 240 | |
| I fosfamide<br>– 50.0 mg/ml | - | ≥ 240 | |
| Mitoxantrone<br>– 2.0 mg/ml | - | ≥ 240 | |
| Vincristine Sulfate<br>– 1.0 mg/ml | - | ≥ 240 | |
| Methotrexate<br>– 25 mg/ml | ≥ 240 | ≥ 240 | |
| Mitomycin C<br>– 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

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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.