(401 days)
Not Found
No
The device is a patient examination glove, and the description and performance studies focus on physical properties, biocompatibility, and chemical resistance, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
This device is a patient examination glove, intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device is a physical glove made of Nitrile Butadiene Rubber, not software. The description details material, physical properties, and testing related to a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used externally.
- Device Description: The description reinforces its function as a glove worn on the hand.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function. It is a physical barrier.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical properties of the glove (pinholes, tensile strength, elongation), biocompatibility, and resistance to chemotherapy drugs. These are relevant to a barrier device, not an IVD.
The fact that it is tested for use with chemotherapy drugs relates to its barrier function and safety for the user when handling such substances, not to any diagnostic capability.
N/A
Intended Use / Indications for 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 as per ASTM D6978-05 (Reapproved 2013) 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
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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.
The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous with beaded-cuff, blue or white colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state.
These gloves were designed and manufactured per ASTM D6319-10 standard, and tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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.
These gloves comply with ASTM D6319-10 and ASTM D5151-11 on water leak test requirements, 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. The physical properties of the subject devices meet the requirements for tensile strength and elongation (both unaged and aged) as stated in ASTM D6319-10 standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject devices were tested against several standards:
- Dimensions: ASTM D6319-10. Results met standard requirements with Length >= 230mm, Palm Thickness >= 0.05mm, Finger Thickness >= 0.05mm, and Widths for various sizes.
- Physical Properties: ASTM D6319-10. Results met standard requirements for Tensile Strength (>= 14 MPa before and after aging) and Elongation (>= 500% before aging, >= 400% after aging).
- Freedom from pinholes: ASTM D5151-11, ASTM D6319-10. Tested in accordance with ASTM D5151 test method. Passed quality level at G1 AQL 1.5.
- Powder Free Residue: ASTM D6124-11, ASTM D6319-10. Result generated values 240 minutes
- Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 minutes
- Cytarabine (100 mg/ml): >240 minutes
- Dacarbazine (DTIC) (10.0 mg/ml): >240 minutes
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Ifosfamide (50.0 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Mitoxantrone (2.0 mg/ml): >240 minutes
- Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes
- Thiotepa (10.0 mg/ml): 30.2 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
- Key Result: Carmustine has extremely low permeation time of less than 30 minutes.
- Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs:
- Carmustine (BCNU) (3.3 mg/ml): 10.1 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 minutes
- Cytarabine (100 mg/ml): >240 minutes
- Dacarbazine (DTIC) (1.0 mg/ml): >240 minutes
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Ifosfamide (50.0 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Mitoxantrone (2.0 mg/ml): >240 minutes
- Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes
- Thiotepa (10.0 mg/ml): 10.4 minutes
- Key Result: Carmustine and Thiotepa have extremely low permeation time of less than 30 minutes respectively.
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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
Kossan International Sdn. Bhd. Cho Sow Fong RA Manager Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 ¾. Jalan Kapar Klang, Selangor 42100 MALAYSIA
Re: K151750
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile. Tested for Use with Chemotherapy Drugs
Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: July 20, 2016 Received: July 28, 2016
Dear Ms. 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, 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
1
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 801); medical device reporting (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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151750
Device Name
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, 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 chemotherapy drugs as 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) | 10.1 |
| 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) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) has extremely low permeation times of 10.1 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.
3
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."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151750
Device Name
Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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 chemotherapy drugs as 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) | 10.1 |
| 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) | 10.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 10.1 minutes and Thiotepa : 10.4 minutes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
_ Prescription Use (Part 21 CFR 801 Subpart D)
∑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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 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."
6
Image /page/6/Picture/0 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the word "KOSSAN" is a grey and white graphic of three crescent shapes. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, grey letters.
FDA 510(k) Premarket Notification 510(k) Summary of Safety and Effectiveness
Date Prepared: August 03, 2016
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.: | +603 3291 0516 |
|---|---|
| Fax No.: | +603 3291 0542 |
2.0 Contact Person:
| Contact: | Ms Cho Sow Fong |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0542 |
3.0 Name of Device:
| Trade Name(s) | : 1. Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile.
Tested for Use with Chemotherapy Drugs
2. Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile.
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, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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. The company's registration number, (273178-M), is also included in the logo.
Predicate Devices:
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
5.0 Description of Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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.
The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous with beaded-cuff, blue or white colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state.
These gloves were designed and manufactured per ASTM D6319-10 standard, and tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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.
These gloves comply with ASTM D6319-10 and ASTM D5151-11 on water leak test requirements, 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.
The physical properties of the subject devices meet the requirements for tensile strength and elongation (both unaged and aged) as stated in ASTM D6319-10 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.
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Image /page/8/Picture/0 description: The image shows the text "KOSSAN INTERNATIONAL SDN. BHD. (273178-M)". The text is in a bold, sans-serif font. The company name is in all caps, and the registration number is in parentheses. The image is likely a logo or header for a document related to the company.
6.0 Intended Use of the Device:
6.1 Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, 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 as 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) | 10.1 |
|---|---|
| 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) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) has extremely low permeation times of 10.1 minutes.
9
Image /page/9/Picture/0 description: The image displays the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in bold, red letters, accompanied by the word "INTERNATIONAL" in gray letters. To the right of the logo is the company's name, "KOSSAN INTERNATIONAL SDN. BHD.," followed by its registration number, (273178-M).
6.2 Device Name: Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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 as 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) | 10.1 |
|---|---|
| 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) | 10.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 10.1 minutes and Thiotepa : 10.4 minutes.
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, processes the following technological characteristic (as compared to ASTM or equivalent standards) as shown in Table below.
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Image /page/10/Picture/0 description: The image is a logo for KOSSAN International. The word "KOSSAN" is in red, and the word "INTERNATIONAL" is in gray. To the left of the word "KOSSAN" is a gray graphic that looks like three curved lines.
| Characteristic | Standards
Requirements | Results Summary | Conclusions | | | | | | | | | |
|--------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--|--|--|--|--|--|--|--|-----------------------------------|
| Dimensions | ASTM D6319-10 | Length $\geq$ 230mm
Palm Thickness $\geq$ 0.05mm
Finger Thickness $\geq$ 0.05mm
Width
X-Small 70-80mm
Small 80-90mm
Medium 90-100mm
Large 101-111mm
X-Large 111-121mm
XX-Large 121-131mm | Meets
Standard
Requirements | | | | | | | | | |
| Physical
Properties | ASTM D6319-10 | Before Aging After Aging Tensile Strength $\geq$ 14 MPA $\geq$ 14 MPA Elongation $\geq$ 500% $\geq$ 400% | | | | | | | | | | Meets
Standard
Requirements |
| Freedom from
pinholes | ASTM D5151-11
ASTM D6319-10 | Tested in accordance with ASTM D5151 test
method. Pass quality level at G1 AQL 1.5 | Meets
Standard
Requirements | | | | | | | | | |
| Powder Free
Residue | ASTM D6124-11
ASTM D6319-10 | Result generated values $\leq$ 2 mg of residual powder
per glove. | Meets
Standard
Requirements | | | | | | | | | |
| Biocompatibility | Dermal Sensitization
(as ISO 10993-
10:2010) | Magnusson &Kligman Scale is '0'.
Under the conditions of the study, the device is not a
sensitizer. | Meets
Standard
Requirements | | | | | | | | | |
| | Primary Skin Irritation
Test (as ISO 10993-
10:2010) | Primary Irritation Index for Erythema and Edema
is '0'.
Under the conditions of the study, the device is not
an irritant. | Meets
Standard
Requirements | | | | | | | | | |
11
Image /page/11/Picture/0 description: The image contains the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the word "KOSSAN" is a grey graphic of three curved lines. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, grey letters.
| Characteristic | Standards
Requirements | Results Summary | Conclusions |
|------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemotherapy
Drugs
Permeation Test | ASTM D6978-05
(Reapproved 2013) | Powder Free Nitrile Patient Examination Glove,
Blue Colored, Non-Sterile, Tested for Use with
Chemotherapy Drugs
Chemotherapy Drug Permeation
(Minimum Breakthrough Detection Time in Minutes)
Carmustine (BCNU) (3.3 mg/ml))
Cisplatin (1.0 mg/ml)
Cyclophosphamide (Cytoxan) (20.0 mg/ml)
Cytarabine (100 mg/ml)
Dacarbazine (DTIC) (10.0 mg/ml)
Doxorubicin Hydrochloride (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2.0 mg/ml)
Paclitaxel (Taxol) (6.0 mg/ml)
Thiotepa (10.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml) | Tested for Use
with
Chemotherapy
Drugs.
Carmustine
has extremely
low
permeation
time of less
than 30
minutes |
| | | Powder Free Nitrile Patient Examination Glove,
White Colored, Non-Sterile, Tested for Use with
Chemotherapy Drugs
Chemotherapy Drug Permeation
(Minimum Breakthrough Detection Time in Minutes)
Carmustine (BCNU) (3.3 mg/ml))
Cisplatin (1.0 mg/ml)
Cyclophosphamide (Cytoxan) (20.0 mg/ml)
Cytarabine (100 mg/ml)
Dacarbazine (DTIC) (1.0 mg/ml)
Doxorubicin Hydrochloride (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2.0 mg/ml)
Paclitaxel (Taxol) (6.0 mg/ml)
Thiotepa (10.0 mg/ml) | Tested for Use
with
Chemotherapy
Drugs.
Carmustine
and Thiotepa
has extremely
low
permeation
time of less
than 30
minutes
respectively |
| | | 10.1
240
240
240
240
240
240
240
240
240
240
240
240
30.2
240 | |
| | | 10.1
240
240
240
240
240
240
240
240
240
240
240
240
10.4 | |
12
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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.
The subject device (Blue and White) have additional size in Double Extra Large compared with predicate K090412 (Pink, Green, Orange and White). The additional sizing provides greater range to cover people with Double Extra Large hand or finger to prevent contamination between patient and examiner. The additional sizing does not affect the safety and effectiveness of the subject device.
There is difference in colorant used in one of the subject device (Blue), compared with predicate K090412 (Pink, Green, Orange and White). The difference does not affect the safety and effectiveness of the subject device (Blue), as the subject device is tested and passed biocompatibility test, similar with predicate devices.
The subject device (Blue and White) were tested with 15 drugs respectively with results in minimum breakthrough time, while predicate K090412 (Pink, Green, Orange and White) was tested with 14 drugs with result in average breakthrough time. The respective drug's permeation result is shown in Indication for Use of the subject device.
The reporting in minimum instead of average breakthrough detection time does not affect the safety and effectiveness of the subject device (Blue and White). The extra drug tested enable users to be more informed on subject device's performance against additional chemotherapy drug tested.
The minimum breakthrough detection time of Carmustine for the subject device (Blue and White) is below 30 minutes, similar with predicate K090412 (Pink, Green, Orange and White).
The minimum permeation time of Thiotepa for subject device is at 30.2 minutes (Blue), and 10.4 minutes (White) respectively. Subject device (Blue) is having longer permeation time than predicate K090412 (Pink, Green, Orange and White); while subject device (White) permeation time is similar with predicate K090412 (Pink, Green, Orange and White), below 30 minutes.
Warning statement (Do Not Use with Carmustine and Thiotepa) for subject device (Blue and White) is included in Labeling, similar with predicate devices.
The subject device (Blue and White) are having similar thickness with predicate K090412 (Pink) at palm, and similar length with predicate K090412 (Pink, Green, Orange and White).
13
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 included to the right of the company name.
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) is having identical specification with predicate K090412 (Pink, Green, Orange and White) with thickness at minimum 0.05 mm and length at minimum 230 mm.
The subject device (Blue and White) was tested at cuff while predicate K090412 (Pink, Green, Orange and White) at palm.
The differences in labeling (with additional drug 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).
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, K090412.
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data was not needed.
10.0 Substantial Equivalent Comparison Table
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the subject device and the predicate device for the substantial equivalent determination.
14
Image /page/14/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 registration number (273178-M) is written in parentheses next to the company name.
Substantial Equivalent Comparison Table
| Characteristics | Subject Device
K151750 | | Predicate Device
K090412 | | | | Comments | |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | Blue | White | Pink | Green | Orange | White | | |
| Manufacturer | Kossan International Sdn Bhd | | GX Corporation Sdn Bhd | | | | N/A | |
| 510(k) Number | K151750 | | K090412 | | | | N/A | |
| Identification | 1. Powder Free Nitrile Patient
Examination Glove, Blue Colored,
Non-Sterile, Tested for Use with
Chemotherapy Drugs
2. Powder Free Nitrile Patient
Examination Glove, White
Colored, Non-Sterile, Tested for
Use with Chemotherapy Drugs | | 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. | | | | N/A | |
| Device Classification
Name/
Regulation Number | Patient Examination Glove/
21 CFR Part 880.6250 | | Patient Examination Glove/
21 CFR Part 880.6250 | | | | Substantially
Equivalent | |
| Product Code | LZA, LZC | | LZA, LZC | | | | Substantially
Equivalent | |
| 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 | | This glove is disposable and intended for
medical purpose that is worn on the examiner's
hand to prevent contamination between patient
and examiner.
This glove is tested for use with Dacarbazine
(DTIC), Mitomycin C, Methotrexate,
Cyclophosphamide (Cytoxan), Mitoxantrone,
Doxorubicin Hydrochloride, Ifosfamide (Ifex),
5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel
(Taxol), Vincristine Sulfate | | | | Substantially
Equivalent | |
| Characteristics | Subject Device
K151750 | | Predicate Device
K090412 | | | | Comments | |
| | Blue | White | Pink | Green | Orange | White | | |
| Materials | Nitrile | | Nitrile | | | | Substantially Equivalent | |
| Color | Blue, and White | | Pink, Green, Orange, White | | | | Substantially Equivalent
Different color, except
white. The difference does
not raise any safety issues | |
| Design | Extra Small
Small
Medium
Large
Extra Large
Double Extra Large | | Meet Requirements of ASTM D6319 | | | | Substantially Equivalent | |
| Single Use | Yes | | Yes | | | | Substantially Equivalent | |
| Sterility | Non-Sterile | | Non-Sterile | | | | Substantially Equivalent | |
| Length | min 230 mm
Meet Requirements of ASTM D6319 | | min 230 mm
Meet Requirements of ASTM D6319 | | | | Substantially Equivalent | |
| Thickness (mm)
- Cuff | 0.032-0.050 | 0.040-0.050 | NA | NA | NA | NA | N/A | |
| - Palm | 0.055-0.085 | 0.055-0.085 | 0.054-
0.083 | 0.073-
0.094 | 0.072-
0.086 | 0.072-
0.094 | Substantially Equivalent
Meet Requirements of
ASTM D6319 | |
| - Finger | 0.065-0.095 | 0.065-0.095 | NA | NA | NA | NA | N/A | |
| Powder Free Residue | ≤ 2mg/glove | | ≤ 2 mg/glove | | | | Substantially Equivalent | |
| Physical Properties | Meet Requirements of ASTM D6319 | | Meet Requirements of ASTM D6319 | | | | Substantially Equivalent | |
| Characteristics | Subject Device
K151750 | | Predicate Device
K090412 | | | Comments | | |
| | Blue | White | Pink | Green | Orange | White | | |
| Biocompatibility Test | Passes
i. Primary Skin Irritation Test –
Not a primary skin irritant under
the conditions of the study
ii. Dermal Sensitization Test –
Not a contact sensitizer under the
conditions of the study | | Passes
i. Primary Skin Irritation Test
ii. Dermal Sensitization Test | | | | Substantially Equivalent | |
| Packaging | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Packed in Dispenser Boxes | | | | Substantially Equivalent | |
| Labeling Features | - Non-sterile - Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color
- Manufactured for:
- Lot Number:
- Quantity by Weight
- Made in Malaysia | - Non-sterile
- Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color
- Manufactured for:
- Lot Number:
- Quantity by Weight
- Made in Malaysia | - Non-sterile
- Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color
- Manufactured for:
- Lot Number:
- Quantity by Weight
- Made in Malaysia | | | | Substantially Equivalent | |
| Characteristics | Subject Device
K151750 | | Predicate Device
K090412 | | | Comments | | |
| Chemotherapy Drugs Permeation
Test | Blue | White | Pink | Green | Orange | White | - | |
| Chemotherapy Drugs
(Concentration) | Minimum Breakthrough
Detection Time in Minutes | | Average Breakthrough Detection
Time in Minutes | | | | | |
| Carmustine (BCNU)
(3.3 mg/ml) | 10.1 | 10.1 | 0.44 | 0.72 | 1.34 | 5.16 | Substantially Equivalent
Below 30 minutes permeation time,
similar with predicate devices | |
| Cisplatin
(1.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Cyclophosphamide (Cytoxan)
(20.0 mg/ml) | > 240 | > 240 | 55.10 | 175.13 | > 240 | > 240 | Substantially Equivalent
Subject device (Blue and White)
having longer permeation than
predicate (Pink and Green) | |
| Cytarabine
(100 mg/ml) | > 240 | > 240 | Not Tested | | | | Additional drug tested for subject
device | |
| Dacarbazine (DTIC)
(10.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Doxorubicin Hydrochloride
(2.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Etoposide
(20.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Fluorouracil
(50.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Ifosfamide
(50.0 mg/ml) | > 240 | > 240 | 68.13 | 160.85 | > 240 | > 240 | Substantially Equivalent
Subject device (Blue and White)
having longer permeation than
predicate (Pink and Green) | |
| Methotrexate
(25.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Mitomycin C
(0.5 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Characteristics | Subject Device
K151750 | Predicate Device
K090412 | | | | Comments | | |
| Chemotherapy Drugs Permeation
Test | Blue | White | Pink | Green | Orange | White | - | |
| Chemotherapy Drugs
(Concentration) | Minimum
Breakthrough
Detection Time in
Minutes | | Average Breakthrough Detection Time in
Minutes | | | | | |
| Mitoxantrone
(2.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Paclitaxel (Taxol)
(6.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Thiotepa
(10.0 mg/ml) | 30.2 | 10.4 | 3.46 | 2.39 | 2.26 | 3.06 | Substantially Equivalent
Subject device (Blue) at 30.2 minute;
Subject device (White) below 30 minutes
permeation time, similar with predicate
(Pink, Green, Orange, White) | |
| Vincristine Sulfate
(1.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Warning statement | WARNING:
Do Not Use with
Carmustine and
Thiotepa | WARNING:
Not
recommended
for use with
Carmustine and
Thiotepa
Caution: the
permeation time
for Cyclo-
phosphamide is
only 55 minutes | | WARNING: Not
recommended for use
with Carmustine and
Thiotepa | | | Substantially Equivalent | |
| Labeling Claim | Tested for Use with
Chemotherapy Drugs | This Product Does Not Contain Thiuram,
and/or Carbamate and/or Thiazole.
Low Dermatitis Potential.
Tested for Use with Chemotherapy
Drugs | | | | | | Subject device do not have claim of
This Product Does Not Contain
Thiuram, and/or Carbamate and/or
Thiazole. Low Dermatitis Potential |
15
Image /page/15/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in large, bold, red letters, with the word "INTERNATIONAL" in smaller, gray letters underneath. To the right of the logo is the company's name, "KOSSAN INTERNATIONAL SDN. BHD.," followed by its registration number in parentheses: (273178-M).
16
Image /page/16/Picture/0 description: The image contains the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the "K" is a red semi-circle with a grey outline. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, grey letters.
17
Image /page/17/Picture/0 description: The image is a logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the word "KOSSAN" is a gray and red graphic design. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, gray letters.
18
Image /page/18/Picture/0 description: The image is a logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the word "KOSSAN" is a gray and red graphic design. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, gray letters.
19
Image /page/19/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 registration number (273178-M) is included next to the company name.
11.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the subject device K151750 is substantially equivalent to the predicate device K090412.