(393 days)
Not Found
No
The device description and performance studies focus on the physical properties, barrier integrity, biocompatibility, and chemotherapy drug permeation of examination gloves, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, serving as a barrier, rather than directly treating or mitigating a disease or condition.
No
The device is a patient examination glove used to prevent contamination, not to diagnose a condition.
No
The device described is a physical medical device (patient examination gloves) and does not involve any software component.
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 during physical examination or procedures.
- Device Description: The description focuses on the physical properties of the glove (material, size, color, powder-free, etc.) and its function as a barrier.
- Performance Studies: The performance studies evaluate the glove's barrier integrity (water leak test), physical properties (tensile strength, elongation), biocompatibility (skin sensitization, irritation), and resistance to chemotherapy drug permeation. These are all related to the glove's function as a protective barrier.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis or provide diagnostic information.
The testing for chemotherapy drug permeation and low dermatitis potential are additional performance characteristics of the glove as a barrier device, not indicators of it being an IVD.
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 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, 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.
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 device underwent non-clinical performance testing and clinical performance testing.
Non-Clinical Performance Data:
The gloves were tested against applicable ASTM standards, including ASTM D6319-10 (Dimensions, Physical Properties, Powder Free Residue), ASTM D5151-11 (Freedom from pinholes), ASTM D6124-11 (Powder Free Residue), ISO 10993-10:2010 (Biocompatibility - Dermal Sensitization and Primary Skin Irritation), and ASTM D6978-05 (Reapproved 2013) (Chemotherapy Drugs Permeation Test).
Key results demonstrated that the device meets all standard requirements for dimensions, physical properties (tensile strength and elongation), freedom from pinholes (pass quality level G1 AQL 1.5), and powder free residue (≤ 2 mg/glove).
Biocompatibility tests showed the device is not a sensitizer and is not an irritant.
Chemotherapy drug permeation tests were conducted for 15 chemotherapy drugs. For the blue glove, Carmustine (BCNU) had a minimum breakthrough detection time of 10.4 minutes, Thiotepa had 90.5 minutes, and all other drugs had >240 minutes. For the white glove, Carmustine (BCNU) had 10.3 minutes, Thiotepa had 70.5 minutes, and all other drugs had >240 minutes. It was noted that Carmustine has extremely low permeation times.
Clinical Performance Data:
A Modified Draize-95 Test was conducted on 200 non-sensitized adult human subjects.
The study was conducted in two stages:
Stage 1: 50 human subjects were tested to evaluate the product for potential irritation or sensitization.
Stage 2: Initiated with additional subjects to reach a total of a minimum of 200 individuals after Stage 1 showed no potential for inducing dermal irritation or sensitization.
Key result: All 200 subjects showed negative results. There was no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy in the un-sensitized general user population in the tested articles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics mentioned include:
- AQL for leakage: 1.5 (exceeding ASTM D6319-10 requirement of 2.5 AQL)
- Powder Free Residue: ≤ 2 mg of residual powder per glove.
- Magnusson & Kligman Scale for Dermal Sensitization: '0' (not a sensitizer)
- Primary Irritation Index for Erythema and Edema: '0' (not an irritant)
- Modified Draize-95 Test: All 200 subjects had a final score of not more than 1.5 during induction and challenge phases, with no clinical evidence of Type IV allergy.
- Minimum Breakthrough Detection Time in Minutes for various chemotherapy drugs (specific values provided in tables for both blue and white gloves).
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 & 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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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.
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
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 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 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.: +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. Low Dermatitis Potential, and
Tested for Use with Chemotherapy Drugs
2. Powder Free Nitrile Patient Examination Glove,
White Colored, Non-Sterile. Low Dermatitis Potential, and
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.
7
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.
8
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.
9
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
10
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
Requirements | Results Summary | Conclusions |
|---------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D6319-10 | Length $\geq$ 240 mm
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 | Meets
Standard
Requirements |
| Physical
Properties | ASTM D6319-10 | Before Aging
Tensile Strength $\geq$ 14 MPA
Elongation $\geq$ 500%
After Aging
$\geq$ 14 MPA
$\geq$ 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 |
| Low Dermatitis
Potential | Modified Draize-95
Test | All 200 subjects had a final score of not more than
1.5 during the induction phase and the challenge
phase.
Under the conditions of the study, there was no
clinical evidence of the presence of residual chemical
additives that may induce Type IV allergy in the un-
sensitized general user population in the tested
articles. | Meets
Standard
Requirements |
| 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. Low Dermatitis Potential, and 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. Low Dermatitis Potential, and 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 |
| | | 10.4
240
240
240
240
240
240
240
240
240
240
240
90.5
240 | |
| | | 10.3
240
240
240
240
240
240
240
240
240
240
240
70.5
240 | |
11
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.
12
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).
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 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.
14
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.
15
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 | ||||||||
| 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 | | Powder-Free Nitrile Patient
Examination Gloves, Blue, Non-
Sterile (Low Dermatitis Potential
and Chemotherapy Drugs
Protection Labeling Claim) | 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 | Patient Examination Glove/
21 CFR Part 880.6250 | | | | Substantially
Equivalent | |
| Product Code | LZA, LZC | | 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
- Standard Practice for
Assessment of Medical Gloves to
Permeation by Chemotherapy
Drugs | | This glove is a disposable device
intended for medical purposes
that is worn on the examiner's
hand to prevent contamination
between patient and examiner.
This glove has been tested for use
with specific 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
K151824 | | Predicate Device 1
K102790 | Predicate Device 2
K090412 | | | | Comments | |
| | Blue | White | Blue | Pink | Green | Orange | White | | |
| Materials | Nitrile | | Nitrile | Nitrile | | | | Substantially
Equivalent | |
| Color | Blue, and White | | Blue | Pink, Green, Orange, White | | | | Subject device
available in Blue
and White Color | |
| Design | Extra Small
Small
Medium
Large
Extra Large | | Extra Small
Small
Medium
Large
Extra Large | Meet Requirements of ASTM
D6319 | | | | Substantially
Equivalent | |
| Single Use | Yes | | Yes | Yes | | | | Substantially
Equivalent | |
| Sterility | Non-Sterile | | Non-Sterile | Non-Sterile | | | | Substantially
Equivalent | |
| Length | Min 240 mm
Meet Requirements of ASTM
D6319 | | Min 240 mm
Meet Requirements of ASTM
D6319 | Min 230 mm
Meet Requirements of ASTM
D6319 | | | | Substantially
Equivalent | |
| Thickness (mm)
- Cuff | 0.052-0.058 | 0.053-0.063 | NA | NA | NA | NA | NA | N/A | |
| - Palm | 0.065-0.085 | 0.065-0.085 | 0.065-0.074 | 0.054-
0.083 | 0.073-
0.094 | 0.072-
0.086 | 0.072-
0.094 | Substantially
Equivalent
Meet Requirements
of ASTM D6319 | |
| - Finger | 0.075-0.095 | 0.075-0.095 | NA | NA | NA | NA | NA | N/A | |
| Powder Free Residue | ≤ 2mg/glove | | ≤ 2 mg/glove | ≤ 2 mg/glove | | | | Substantially
Equivalent | |
| Physical Properties | Meet Requirements of ASTM
D6319 | | Meet Requirements of ASTM
D6319 | Meet Requirements of ASTM
D6319 | | | | Substantially
Equivalent | |
| Characteristics | Subject Device
K151824 | | Predicate Device 1
K102790 | Predicate Device 2
K090412 | | | | Comments | |
| | Blue | White | Blue | 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 - 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 -
Not a primary skin irritant
ii. Dermal Sensitization Test -
Not a contact sensitizer | Passes
i. Primary Skin Irritation Test -
Not a primary skin irritant
ii. Dermal Sensitization Test -
Not a contact sensitizer | Passes
i. Primary Skin Irritation Test -
Not a primary skin irritant
ii. Dermal Sensitization Test -
Not a contact sensitizer | Passes
i. Primary Skin Irritation Test -
Not a primary skin irritant
ii. Dermal Sensitization Test -
Not a contact sensitizer | Passes
i. Primary Skin Irritation Test -
Not a primary skin irritant
ii. Dermal Sensitization Test -
Not a contact sensitizer | Substantially
Equivalent | |
| | | | | | | | | | |
| Modified Draize Test | Under the conditions of the
study, there was no clinical
evidence of the presence of
residual chemical additives that
may induce Type IV allergy in
the un-sensitized general user
population in the tested articles. | | Under the conditions of a
repeated insult (occlusive) patch
test procedure, test article was
'Dermatologist-Tested' and did
not induce clinically significant
skin irritation nor show any
evidence of induced allergic
contact dermatitis in human
subjects. | There is 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 articles. | | | | 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
K151824 | | Predicate Device 1
K102790 | Predicate Device 2
K090412 | | | Comments | | |
| | Blue | White | Blue | Pink | Green | Orange | White | | |
| Labeling Claim | 1. Low Dermatitis Potential
- Tested for Use with
Chemotherapy Drugs | | 1. Low Dermatitis Potential - Chemotherapy Drugs
Protection Labeling Claim | 1. -
| Low Dermatitis Potential
Tested For Use with
Chemotherapy Drugs
This Product Does Not
Contain Thiuram, and/or
Carbamate and/or
Thiazole. | | | Substantially
Equivalent
- Predicate device 2
K090412 has
additional claim on
"This Product Does
Not Contain Thiuram
and/or Carbamate
and/or Thiazole" | |
| Characteristics | Subject Device
K151824 | Predicate 1
K102790 | Predicate 2
K090412 | | | | Comments | | |
| Chemotherapy Drugs
Permeation Test | Blue | White | Blue | 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) | 10.4 | 10.3 | 16.70 | 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 | > 240 | Substantially Equivalent | |
| Cyclophosphamide (Cytoxan)
(20.0 mg/ml) | > 240 | > 240 | > 240 | 55.10 | 175.13 | > 240 | > 240 | Substantially Equivalent
Subject device (Blue and
White) having longer
permeation than predicate
K090412(Pink and Green) | |
| Cytarabine
(100 mg/ml) | > 240 | > 240 | Not Tested | | Not Tested | | | Additional drug tested for
subject device | |
| Dacarbazine (DTIC)
(10.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Doxorubicin Hydrochloride
(2.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Etoposide
(20.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Fluorouracil
(50.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Ifosfamide
(50.0 mg/ml) | > 240 | > 240 | Not Tested | 68.13 | 160.85 | > 240 | > 240 | Substantially Equivalent
Subject device (Blue and
White) having longer
permeation than predicate
K090412(Pink and Green) | |
| Methotrexate
(25.0 mg/ml) | > 240 | > 240 | Not Tested | > 240 | > 240 | > 240 | > 240 | Substantially Equivalent | |
| Characteristics | Subject Device
K151824 | | Predicate 1
K102790 | Predicate 2
K090412 | | | | Comments | |
| Chemotherapy Drugs
Permeation Test | Blue | White | Blue | Pink | Green | Orange | White | | |
| Chemotherapy Drugs
(Concentration) | | Minimum Breakthrough
Detection Time in Minutes | | | Average Breakthrough
Detection Time in Minutes | | | | |
| Mitomycin C
(0.5 mg/ml) | > 240 | > 240 | Not Tested | > 240 | > 240 | > 240 | > 240 | Substantially
Equivalent | |
| Mitoxantrone
(2.0 mg/ml) | > 240 | > 240 | Not Tested | > 240 | > 240 | > 240 | > 240 | Substantially
Equivalent | |
| Paclitaxel (Taxol)
(6.0 mg/ml) | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | > 240 | Substantially
Equivalent | |
| Thiotepa
(10.0 mg/ml) | 90.5 | 70.5 | 72.36 | 3.46 | 2.39 | 2.26 | 3.06 | Substantially
Equivalent
Similar with Predicate
K102790, at range of
30 and 90 minutes, and
longer than predicate
K090412. | |
| Vincristine Sulfate
(1.0 mg/ml) | > 240 | > 240 | Not Tested | > 240 | > 240 | > 240 | > 240 | Substantially
Equivalent | |
| Warning statement | WARNING:
Not to be used with
Carmustine. | | Please note that
Carmustine has
extremely low
permeation
times of less
than 30 minutes. | WARNING:
Not
recommended
for use with
Carmustine
and Thiotepa
Caution: the
permeation
time for
Cyclo-
phosphamide
is only 55
minutes | | | | Substantially
Equivalent | |
16
Image /page/16/Picture/0 description: The image shows the logo for KOSSAN International. The logo features a stylized letter 'C' in gray with red accents, followed by the word "KOSSAN" in bold red letters. Below "KOSSAN" is the word "INTERNATIONAL" in gray.
17
Image /page/17/Picture/0 description: The image shows the logo for KOSSAN International. The logo features a stylized red "KOSSAN" with a gray circular design to the left. Below "KOSSAN" is the word "INTERNATIONAL" in gray, smaller font. The logo is clean and professional.
18
Image /page/18/Picture/0 description: The image shows the logo for KOSSAN International. The logo features a stylized red "KOSSAN" text with a grey circular design to the left. Below the red text, the word "INTERNATIONAL" is written in grey.
19
Image /page/19/Picture/0 description: The image shows the 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 and red circular design.
20
Image /page/20/Picture/0 description: The image is a logo for KOSSAN International. The word "KOSSAN" is in red, bold letters, and the word "INTERNATIONAL" is in gray, smaller letters, and is located below the word "KOSSAN". To the left of the word "KOSSAN" is a gray and red circular design.