Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

K151824 · Kossan International Sdn Bhd · LZA · Aug 2, 2016 · General Hospital

Device Facts

• Record ID: K151824
• Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
• Applicant: Kossan International Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Aug 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, ambidextrous nitrile butadiene rubber gloves; available in blue or white; five sizes (XS-XL). Designed to provide a barrier between patient and examiner to prevent cross-contamination. Tested for permeation resistance against 15 chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is a physical barrier; healthcare providers use the glove to maintain hygiene during patient examinations. Benefits include protection against patient-to-examiner contamination and exposure to specific chemotherapy agents.

Clinical Evidence

No clinical trials performed. Evidence based on bench testing and biocompatibility studies. Modified Draize-95 test conducted on 200 non-sensitized adult human subjects showed no clinical evidence of residual chemical additives inducing Type IV allergy. Biocompatibility testing (ISO 10993-10:2010) confirmed the device is not a primary skin irritant or contact sensitizer.

Technological Characteristics

Material: Nitrile Butadiene Rubber. Dimensions: Length ≥ 240mm, thickness ≥ 0.05mm. Standards: ASTM D6319-10 (physical properties, dimensions), ASTM D5151-11 (leakage), ASTM D6124-11 (powder residue), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-10:2010. Non-sterile, powder-free, ambidextrous, beaded cuff.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for use with 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

• Powder Free Nitrile Patient Examination Glove (K120066)
• Powder Free Nitrile Examination Gloves (K090412)
• Powder-Free Nitrile Patient Examination Gloves (K102790)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 2, 2016

Kossan International Sdn. Bhd. Ms. Cho Sow Fong RA Manager Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 3/4, Jalan Kapar 42100 Klang, Selangor Malaysia

Re: K151824

Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Nonsterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Powder Free Nitrile Patient Examination Glove, White Colored, Nonsterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: July 20, 2016 Received: July 25, 2016

Dear Cho Sow Fong:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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

510(k) Number (if known)

K151824

### Device Name

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile. Low Dermatiis Potential, and Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

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

These gloves were tested for use with cherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|-----------------------------------------|------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 10.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 90.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that Carmustine (BCNU) has extremely low permeation times of 10.4 minutes.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 [e-mail]

"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."

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## Indications for Use

510(k) Number (if known)

### Device Name

Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

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

These gloves were tested for use with cherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|-----------------------------------------|------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 10.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 70.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that Carmustine (BCNU) has extremely low permeation times of 10.3 minutes.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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 [e-mail]

"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."

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Image /page/6/Picture/0 description: The image shows the text "KOSSAN INTERNATIONAL SDN. BHD. (273178-M)". The text is in bold and is centered in the image. The text appears to be the name of a company and its registration number.

Image /page/6/Picture/1 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in red, and the word "INTERNATIONAL" is in gray. There is a gray graphic to the left of the word "KOSSAN" that looks like a crescent moon.

# FDA 510(k) Premarket Notification 510(k) Summary of Safety and Effectiveness

# Date Prepared: August 2, 2016 (TCK)

### 1.0 Submitter:

Kossan International Sdn. Bhd. Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 ¾. Jalan Kapar, 42100 Klang, Selangor, Malaysia

Telephone No.: [phone] Fax No.: [phone]

#### 2.0 Contact Person:

| Contact: | Ms Cho Sow Fong |
|----------------|-----------------|
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

### 3.0 Name of Device :

| Trade Name(s) | : 1. Powder Free Nitrile Patient Examination Glove,<br>Blue Colored, Non-Sterile. Low Dermatitis Potential, and<br>Tested for Use with Chemotherapy Drugs<br>2. Powder Free Nitrile Patient Examination Glove,<br>White Colored, Non-Sterile. Low Dermatitis Potential, and<br>Tested for Use with Chemotherapy Drugs |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Powder-Free Nitrile Patient Examination Glove |
| Classification Name | : Patient Examination Glove |
| Regulation Number | : 21 CFR 880.6250 |
| Classification Number | : Class I |
| Product Code | : LZA, LZC |

#### 4.0 Identification of the Legally Marketed Device:

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Class I Patient Examination Gloves, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

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Image /page/7/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in red, with the word "INTERNATIONAL" in gray underneath. To the right of the logo is the company name, "KOSSAN INTERNATIONAL SDN. BHD." followed by the registration number (273178-M).

## Predicate Devices:

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove. White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs - were previously cleared under 510(k) K120066 (product code LZA).

Predicate Device: K090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange, White). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs; Product code: LZA, LZC

Predicate Device: K102790 Powder-Free Nitrile Patient Examination Gloves, Blue, Non-Sterile (Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim); Product code: LZA, LZC

### 5.0 Description of De vice :

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, and Modified-Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999".

The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous (i.e. can be worn on right hand or left hand) with beaded cuff, blue or white colored, singleuse disposable devices, that come in five sizes (XS. S. M. L. XL), and supplied in Non-Sterile state.

The principle operating characteristic of the device is to prevent contamination between patient and examiner, achieving through conformance of barrier, physical properties and other testing requirements as stated in Section 7.0 of this 510(k) Summary.

The gloves are also complied with ASTM D6319-10 and ASTM D5151-11 on water leak test, forming a barrier to prevent contamination between patient and examiner. Testing of the subject device shows it meets the 1.5 AQL for leakage, exceeding ASTM D6319-10 requirement of 2.5 AQL for leakage.

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The gloves are designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The physical properties of the subject device meet the requirements for tensile strength and elongation (both unaged and aged) in the standard.

The results (summarized in Section 7.0) demonstrated that the subject devices meets various relevant established standards and are acceptable to for their intended use, to prevent contamination between patient and examiner.

#### 6.0 Intended Use of the Device:

### Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, 6.1 Non-Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes

| Carmustine (BCNU) (3.3 mg/ml) | 10.4 |
|-----------------------------------------|------|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 90.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that Carmustine (BCNU) has extremely low permeation times of 10.4 minutes.

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### 6.2 Device Name: Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|-------------------------------------|------------------------------------------------|
|-------------------------------------|------------------------------------------------|

| Carmustine (BCNU) (3.3 mg/ml) | 10.3 |
|-----------------------------------------|------|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 70.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that Carmustine (BCNU) has extremely low permeation times of 10.3 minutes.

### 7.0 Summary of the Technological Characteristics of the Device:

Powder Free Nitrile Patient Examination Glove. Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, processes the following technological characteristic (as compared to ASTM or equivalent standards), as shown in Table below.

Chemotherapy claim is similar to Predicate, which has a glove thickness below 0.10 than 270mm but compliant with ASTM standards. mm and is shorter

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Image /page/10/Picture/0 description: The image is a logo for KOSSAN International. The logo features a stylized letter "K" with a red color scheme and a gray circular element surrounding the "K". Below the main logo, the word "INTERNATIONAL" is written in gray, block letters. The logo appears to be for a company that operates on an international scale.

| Characteristic | Standards<br>Requirements | Results Summary | Conclusions |
|---------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D6319-10 | Length $\geq$ 240 mm<br>Palm Thickness $\geq$ 0.05mm<br>Finger Thickness $\geq$ 0.05mm<br>Width<br>X-Small 70-80mm<br>Small 80-90mm<br>Medium 90-100mm<br>Large 101-111mm<br>X-Large 111-121mm | Meets<br>Standard<br>Requirements |
| Physical<br>Properties | ASTM D6319-10 | Before Aging<br>Tensile Strength $\geq$ 14 MPA<br>Elongation $\geq$ 500%<br>After Aging<br>$\geq$ 14 MPA<br>$\geq$ 400% | Meets<br>Standard<br>Requirements |
| Freedom from<br>pinholes | ASTM D5151-11<br>ASTM D6319-10 | Tested in accordance with ASTM D5151 test<br>method. Pass quality level at G1 AQL 1.5 | Meets<br>Standard<br>Requirements |
| Powder Free<br>Residue | ASTM D6124-11<br>ASTM D6319-10 | Result generated values $\leq$ 2 mg of residual powder<br>per glove. | Meets<br>Standard<br>Requirements |
| Biocompatibility | Dermal Sensitization<br>(as ISO 10993-<br>10:2010) | Magnusson &Kligman Scale is '0'.<br>Under the conditions of the study, the device is not a<br>sensitizer. | Meets<br>Standard<br>Requirements |
| | Primary Skin Irritation<br>Test (as ISO 10993-<br>10:2010) | Primary Irritation Index for Erythema and Edema<br>is '0'.<br>Under the conditions of the study, the device is not<br>an irritant. | Meets<br>Standard<br>Requirements |
| Low Dermatitis<br>Potential | Modified Draize-95<br>Test | All 200 subjects had a final score of not more than<br>1.5 during the induction phase and the challenge<br>phase.<br>Under the conditions of the study, there was no<br>clinical evidence of the presence of residual chemical<br>additives that may induce Type IV allergy in the un-<br>sensitized general user population in the tested<br>articles. | Meets<br>Standard<br>Requirements |
| Characteristic | Standards Requirements | Results Summary | Conclusions |
| Chemotherapy Drugs<br>Permeation Test | ASTM D6978-05<br>(Reapproved 2013) | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs<br><br>Chemotherapy Drug Permeation<br>(Minimum Breakthrough Detection Time in Minutes)<br>Carmustine (BCNU) (3.3 mg/ml))<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (Cytoxan) (20.0 mg/ml)<br>Cytarabine (100 mg/ml)<br>Dacarbazine (DTIC) (10.0 mg/ml)<br>Doxorubicin Hydrochloride (2.0 mg/ml)<br>Etoposide (20.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Ifosfamide (50.0 mg/ml)<br>Methotrexate (25.0 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2.0 mg/ml)<br>Paclitaxel (Taxol) (6.0 mg/ml)<br>Thiotepa (10.0 mg/ml)<br>Vincristine Sulfate (1.0 mg/ml) | Tested for Use with Chemotherapy Drugs.<br><br>Carmustine has extremely low permeation time of less than 30 minutes |
| | | Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs<br><br>Chemotherapy Drug Permeation<br>(Minimum Breakthrough Detection Time in Minutes)<br>Carmustine (BCNU) (3.3 mg/ml))<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (Cytoxan) (20.0 mg/ml)<br>Cytarabine (100 mg/ml)<br>Dacarbazine (DTIC) (10.0 mg/ml)<br>Doxorubicin Hydrochloride (2.0 mg/ml)<br>Etoposide (20.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Ifosfamide (50.0 mg/ml)<br>Methotrexate (25.0 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2.0 mg/ml)<br>Paclitaxel (Taxol) (6.0 mg/ml)<br>Thiotepa (10.0 mg/ml)<br>Vincristine Sulfate (1.0 mg/ml) | Tested for Use with Chemotherapy Drugs.<br><br>Carmustine has extremely low permeation time of less than 30 minutes |
| | | <b>10.4</b><br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br><b>90.5</b><br>>240 | |
| | | <b>10.3</b><br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br>>240<br><b>70.5</b><br>>240 | |

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Image /page/11/Picture/0 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. To the left of the word is a gray graphic of three curved lines that form a semi-circle. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, gray letters.

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Image /page/12/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The word "KOSSAN" is in red, and the word "INTERNATIONAL" is in gray. The company's registration number, (273178-M), is listed to the right of the company name.

#### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs: and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, have been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.

Modified Draize-95 test completed on 200 non-sensitized adult human subjects that reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residue chemical additives at the level that may induce Type IV allergy in the un-sensitized general user population in the tested article.

Subject device (Blue and White) was previously cleared under K120066 without tested for used with chemotherapy drugs. Predicate K102790 is tested for use with chemotherapy drugs for Blue, while Predicate K090412 has four colors (Pink, Green, Orange, and White) tested for use with chemotherapy drugs.

The different in color does not affect the safety and effectiveness of the subject device, as the subject device (Blue and White) was tested and passed Biocompatibility test, and Modified Draize-95 test, similar with predicate devices.

The subject device were tested for 15 drugs for both Blue and White, while predicate device K102790 tested 9 drugs, and K090412 tested 14 drugs. The subject device is with results in minimum breakthrough time, while predicate K102790 and K090412 are with result in average breakthrough time.

The reporting in minimum instead of average breakthrough detection time does not affect the safety and effectiveness of the subject device. The extra drug tested enable users to be more informed on subject device's performance against additional chemotherapy drug tested. The respective drug's permeation result is shown in Indication for Use of the subject devices.

The minimum performance of Carmustine for the subject device (Blue and White) is below 30 minutes, similar with predicate K102790 and K090412. Warning statement (Not to be used with Carmustine) for subject device is included in Labeling, similar with predicate devices.

The minimum permeation time of Thiotepa for subject device is 90.5 minutes (Blue) and 70.5 minutes (White) respectively, similar with predicate K102790 permeation time at 72.36 minutes, both above 30 minutes and below 90 minutes; and longer than predicate K090412 (Pink, Green, Orange, White).

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Image /page/13/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in red, with the word "INTERNATIONAL" in gray underneath. The company's registration number, (273178-M), is also included in the logo.

The subject device (Blue and White) are having similar thickness with Predicate K102790 (Blue), and thicker than K090412 (Pink) at palm. The subject device (Blue and White) are having similar length with Predicate K090412 (Pink, Green, Orange, White) at minimum 240 mm.

In addition, the subject device (Blue and White) tested is having longer permeation than predicate K090412 (Pink) for Cyclophosphamide (Cytoxan) and Ifosfamide. The subject device (Blue and White) is also having longer permeation than predicate K090412 (Green) for Cyclophosphamide (Cytoxan) and Ifosfamide.

The subject device (Blue and White) was tested at cuff while predicate K102790 and predicate K090412 (Pink, Green, Orange and White) at palm.

The differences in labeling (with additional drugs tested, reporting in minimum breakthrough time instead of average, testing location, and the permeation time) do not affect the safety and effectiveness of the subject device (Blue and White).

Chemotherapy claim is similar to Predicate K102790 and K090412 (Pink, Green, Orange, White), which has a glove thickness below 0.10 mm and is shorter than 270 mm but compliant with ASTM standards.

The subject device (Blue and White) and the predicate devices share the same intended use, same Nitrile material, and same compliant with ASTM standards. There is no difference between the subject device (Blue and White) and the predicate devices with respect to intended use, non-clinical performance data and technological characteristics.

Consequently, the gloves that are the subject of this submission are substantially equivalent to a legally marketed glove, K102790 and K090412.

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#### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, were tested in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999".

The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability.

The study completed on 200 non-sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce Type IV allergy in the un-sensitized general user population in the tested article.

#### 10.0 Conclusion

Substantial Equivalent Comparison Table below outlines the similarity, and/or The differences between the subject device and the predicate device for the substantial equivalent determination.

Based on intended uses, technological characteristics and non-clinical performance data, the subject device K151824 is substantially equivalent to the predicate devices K102790 and K090412.

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Image /page/15/Picture/0 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. To the left of the word is a grey graphic of three curved lines. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, grey letters.

# Substantial Equivalent Comparison Table

| | Subject Device | | Predicate Device 1 | Predicate Device 2 | | | | | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Characteristics | Blue | White | Blue | Pink | Green | Orange | White | Comments | |
| Manufacturer | Kossan International Sdn Bhd | Kossan International Sdn Bhd | Perusahaan Getah Asas Sdn Bhd | GX Corporation Sdn. Bhd. | | | | N/A | |
| 510(k) Number | K151824 | | K102790 | K090412 | | | | N/A | |
| Identification | 1. Powder Free Nitrile Patient<br>Examination Glove, Blue<br>Colored, Non-Sterile.<br>Low Dermatitis Potential, and<br>Tested for Use with<br>Chemotherapy Drugs<br>2. Powder Free Nitrile Patient<br>Examination Glove, White<br>Colored, Non-Sterile.<br>Low Dermatitis Potential, and<br>Tested for Use with<br>Chemotherapy Drugs | | Powder-Free Nitrile Patient<br>Examination Gloves, Blue, Non-<br>Sterile (Low Dermatitis Potential<br>and Chemotherapy Drugs<br>Protection Labeling Claim) | Powder Free Nitrile Examination<br>Gloves (Pink, Green, Orange,<br>White).<br>This Product Does Not Contain<br>Thiuram, and/or Carbamate<br>and/or Thiazole. Low Dermatitis<br>Potential.<br>Tested for Use with Chemotherapy<br>Drugs. | | | | N/A | |
| Device Classification<br>Name/<br>Regulation Number | Patient Examination Glove/<br>21 CFR Part 880.6250 | | Patient Examination Glove/<br>21 CFR Part 880.6250 | Patient Examination Glove/<br>21 CFR Part 880.6250 | | | | Substantially<br>Equivalent | |
| Product Code | LZA, LZC | | LZA, LZC | LZA, LZC | | | | Substantially<br>Equivalent | |
| Intended Use | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient and<br>examiner.<br>These gloves were tested for use<br>with chemotherapy drugs per<br>ASTM D6978-05 (Reapproved<br>2013) Standard Practice for<br>Assessment of Medical Gloves to<br>Permeation by Chemotherapy<br>Drugs | | This glove is a disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent contamination<br>between patient and examiner.<br>This glove has been tested for use<br>with specific chemotherapy<br>drugs. | This glove is disposable and<br>intended for medical purpose that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner.<br>This glove is tested for use with<br>Dacarbazine (DTIC), Mitomycin C,<br>Methotrexate, Cyclophosphamide<br>(Cytoxan), Mitoxantrone,<br>Doxorubicin Hydrochloride,<br>Ifosfamide (Ifex), 5-Fluorouracil,<br>Cisplatin, Etoposide, Paclitaxel<br>(Taxol), Vincristine Sulfate | | | | Substantially<br>Equivalent | |
| Characteristics | Subject Device<br>K151824 | | Predicate Device 1<br>K102790 | Predicate Device 2<br>K090412 | | | | Comments | |
| | Blue | White | Blue | Pink | Green | Orange | White | | |
| Materials | Nitrile | | Nitrile | Nitrile | | | | Substantially<br>Equivalent | |
| Color | Blue, and White | | Blue | Pink, Green, Orange, White | | | | Subject device<br>available in Blue<br>and White Color | |
| Design | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Meet Requirements of ASTM<br>D6319 | | | | Substantially<br>Equivalent | |
| Single Use | Yes | | Yes | Yes | | | | Substantially<br>Equivalent | |
| Sterility | Non-Sterile | | Non-Sterile | Non-Sterile | | | | Substantially<br>Equivalent | |
| Length | Min 240 mm<br>Meet Requirements of ASTM<br>D6319 | | Min 240 mm<br>Meet Requirements of ASTM<br>D6319 | Min 230 mm<br>Meet Requirements of ASTM<br>D6319 | | | | Substantially<br>Equivalent | |
| Thickness (mm)<br>- Cuff | 0.052-0.058 | 0.053-0.063 | NA | NA | NA | NA | NA | N/A | |
| - Palm |…