(401 days)
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.
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 provided document describes the acceptance criteria and performance data for two types of Powder Free Nitrile Patient Examination Gloves (blue and white colored) tested for use with chemotherapy drugs.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by various ASTM standards. The reported device performance is presented as a "Results Summary" or direct values.
| Characteristic | Standard Requirements | Reported Device Performance (Summary / Blue Glove) | Reported Device Performance (Summary / White Glove) |
|---|---|---|---|
| Dimensions | ASTM D6319-10: Length ≥ 230mm, Palm Thickness ≥ 0.05mm, Finger Thickness ≥ 0.05mm, Widths for XS-XXL | Meets Standard Requirements (Specific ranges for Length, Palm/Finger Thickness, and Width are provided in the source for each size, all falling within or exceeding the standard requirements) | Meets Standard Requirements (Specific ranges for Length, Palm/Finger Thickness, and Width are provided in the source for each size, all falling within or exceeding the standard requirements) |
| Physical Properties | ASTM D6319-10: Before Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 500%; After Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 400% | Meets Standard Requirements (Table states values met) | Meets Standard Requirements (Table states values met) |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10: Pass quality level at G1 AQL 1.5 | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10: ≤ 2 mg of residual powder per glove | Result generated values ≤ 2 mg of residual powder per glove. | Result generated values ≤ 2 mg of residual powder per glove. |
| Biocompatibility | Dermal Sensitization (ISO 10993-10:2010), Primary Skin Irritation Test (ISO 10993-10:2010) | Magnusson & Kligman Scale is '0' (not a sensitizer). Primary Irritation Index for Erythema and Edema is '0' (not an irritant). | Magnusson & Kligman Scale is '0' (not a sensitizer). Primary Irritation Index for Erythema and Edema is '0' (not an irritant). |
| Chemotherapy Drugs Permeation Test (ASTM D6978-05) | No explicit general "acceptance criteria" is listed beyond the standard itself. Performance is measured by Minimum Breakthrough Detection Time. | Carmustine (BCNU) (3.3 mg/ml): 10.1 minCisplatin (1.0 mg/ml): >240 minCyclophosphamide (Cytoxan) (20.0 mg/ml): >240 minCytarabine (100 mg/ml): >240 minDacarbazine (DTIC) (10.0 mg/ml): >240 minDoxorubicin Hydrochloride (2.0 mg/ml): >240 minEtoposide (20.0 mg/ml): >240 minFluorouracil (50.0 mg/ml): >240 minIfosfamide (50.0 mg/ml): >240 minMethotrexate (25.0 mg/ml): >240 minMitomycin C (0.5 mg/ml): >240 minMitoxantrone (2.0 mg/ml): >240 minPaclitaxel (Taxol) (6.0 mg/ml): >240 minThiotepa (10.0 mg/ml): 30.2 minVincristine Sulfate (1.0 mg/ml): >240 min | Carmustine (BCNU) (3.3 mg/ml): 10.1 minCisplatin (1.0 mg/ml): >240 minCyclophosphamide (Cytoxan) (20.0 mg/ml): >240 minCytarabine (100 mg/ml): >240 minDacarbazine (DTIC) (1.0 mg/ml): >240 minDoxorubicin Hydrochloride (2.0 mg/ml): >240 minEtoposide (20.0 mg/ml): >240 minFluorouracil (50.0 mg/ml): >240 minIfosfamide (50.0 mg/ml): >240 minMethotrexate (25.0 mg/ml): >240 minMitomycin C (0.5 mg/ml): >240 minMitoxantrone (2.0 mg/ml): >240 minPaclitaxel (Taxol) (6.0 mg/ml): >240 minThiotepa (10.0 mg/ml): 10.4 minVincristine Sulfate (1.0 mg/ml): >240 min |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively refers to testing according to specific ASTM and ISO standards for various characteristics. While these standards implicitly define sample sizes and testing methodologies, the exact sample sizes used for each specific test (e.g., number of gloves for pinhole test, number of samples for chemotherapy drug permeation) are not explicitly stated in the provided text.
- Data Provenance: The manufacturer is Kossan International Sdn. Bhd., located in Malaysia. It is highly probable the testing and data originate from Malaysia or laboratories contracted by the Malaysian manufacturer. The data appears to be prospective as it involves the performance testing of new devices against established standards prior to market approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device and study. The "ground truth" here is not established by human experts interpreting data. Instead, it is defined by objective, quantifiable physical and chemical properties measured according to standardized methods (ASTM, ISO). For example, the breakthrough time for chemotherapy drugs is a direct measurement, not an expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for ambiguous cases in diagnostic studies. The performance testing for these gloves relies on direct, objective measurements against pre-defined physical and chemical standards, not on subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This document describes the performance of a patient examination glove, a physical medical device. It does not involve any imaging, diagnostic algorithms, or human reader interpretation, nor does it concern AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. As stated above, this is a physical medical device (gloves) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the objective performance metrics and thresholds established by recognized national and international standards. For example:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978-05 (Reapproved 2013) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
The "ground truth" is therefore based on standardized test methods and predetermined quantitative criteria.
8. The sample size for the training set
This question is not applicable. This device is a physical product and does not involve AI/ML models that require a "training set." The testing described evaluates the manufactured product's inherent physical and chemical properties.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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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
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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
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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.
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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.
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."
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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 Drugs2. 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.
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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 | StandardsRequirements | Results Summary | Conclusions | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dimensions | ASTM D6319-10 | Length $\geq$ 230mmPalm Thickness $\geq$ 0.05mmFinger Thickness $\geq$ 0.05mmWidthX-Small 70-80mmSmall 80-90mmMedium 90-100mmLarge 101-111mmX-Large 111-121mmXX-Large 121-131mm | MeetsStandardRequirements | |||||||||
| PhysicalProperties | ASTM D6319-10 | Before Aging After Aging Tensile Strength $\geq$ 14 MPA $\geq$ 14 MPA Elongation $\geq$ 500% $\geq$ 400% | MeetsStandardRequirements | |||||||||
| Freedom frompinholes | ASTM D5151-11ASTM D6319-10 | Tested in accordance with ASTM D5151 testmethod. Pass quality level at G1 AQL 1.5 | MeetsStandardRequirements | |||||||||
| Powder FreeResidue | ASTM D6124-11ASTM D6319-10 | Result generated values $\leq$ 2 mg of residual powderper glove. | MeetsStandardRequirements | |||||||||
| Biocompatibility | Dermal Sensitization(as ISO 10993-10:2010) | Magnusson &Kligman Scale is '0'.Under the conditions of the study, the device is not asensitizer. | MeetsStandardRequirements | |||||||||
| Primary Skin IrritationTest (as ISO 10993-10:2010) | Primary Irritation Index for Erythema and Edemais '0'.Under the conditions of the study, the device is notan irritant. | MeetsStandardRequirements |
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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 | StandardsRequirements | Results Summary | Conclusions |
|---|---|---|---|
| ChemotherapyDrugsPermeation Test | ASTM D6978-05(Reapproved 2013) | Powder Free Nitrile Patient Examination Glove,Blue Colored, Non-Sterile, Tested for Use withChemotherapy DrugsChemotherapy 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 UsewithChemotherapyDrugs.Carmustinehas extremelylowpermeationtime of lessthan 30minutes |
| Powder Free Nitrile Patient Examination Glove,White Colored, Non-Sterile, Tested for Use withChemotherapy DrugsChemotherapy 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 UsewithChemotherapyDrugs.Carmustineand Thiotepahas extremelylowpermeationtime of lessthan 30minutesrespectively | ||
| 10.1>240>240>240>240>240>240>240>240>240>240>240>24030.2>240 | |||
| 10.1>240>240>240>240>240>240>240>240>240>240>240>24010.4 |
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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).
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Image /page/13/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in red, with the word "INTERNATIONAL" in gray underneath. The company's registration number, (273178-M), is 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.
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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 DeviceK151750 | Predicate DeviceK090412 | 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 PatientExamination Glove, Blue Colored,Non-Sterile, Tested for Use withChemotherapy Drugs2. Powder Free Nitrile PatientExamination Glove, WhiteColored, Non-Sterile, Tested forUse with Chemotherapy Drugs | Powder Free Nitrile Examination Gloves(Pink, Green, Orange, White). This ProductDoes Not Contain Thiuram, and/or Carbamateand/or Thiazole. Low Dermatitis Potential.Tested for Use with Chemotherapy Drugs. | N/A | |||||
| Device ClassificationName/Regulation Number | Patient Examination Glove/21 CFR Part 880.6250 | Patient Examination Glove/21 CFR Part 880.6250 | SubstantiallyEquivalent | |||||
| Product Code | LZA, LZC | LZA, LZC | SubstantiallyEquivalent | |||||
| Intended Use | A patient examination glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer.These gloves were tested for use withchemotherapy drugs per ASTMD6978-05 (Reapproved 2013)Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs | This glove is disposable and intended formedical purpose that is worn on the examiner'shand to prevent contamination between patientand 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 | SubstantiallyEquivalent | |||||
| Characteristics | Subject DeviceK151750 | Predicate DeviceK090412 | Comments | |||||
| Blue | White | Pink | Green | Orange | White | |||
| Materials | Nitrile | Nitrile | Substantially Equivalent | |||||
| Color | Blue, and White | Pink, Green, Orange, White | Substantially EquivalentDifferent color, exceptwhite. The difference doesnot raise any safety issues | |||||
| Design | Extra SmallSmallMediumLargeExtra LargeDouble 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 mmMeet Requirements of ASTM D6319 | min 230 mmMeet 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 EquivalentMeet Requirements ofASTM 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 DeviceK151750 | Predicate DeviceK090412 | Comments | |||||
| Blue | White | Pink | Green | Orange | White | |||
| Biocompatibility Test | Passesi. Primary Skin Irritation Test –Not a primary skin irritant underthe conditions of the studyii. Dermal Sensitization Test –Not a contact sensitizer under theconditions of the study | Passesi. Primary Skin Irritation Testii. 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 DeviceK151750 | Predicate DeviceK090412 | Comments | |||||
| Chemotherapy Drugs PermeationTest | Blue | White | Pink | Green | Orange | White | - | |
| Chemotherapy Drugs(Concentration) | Minimum BreakthroughDetection Time in Minutes | Average Breakthrough DetectionTime in Minutes | ||||||
| Carmustine (BCNU)(3.3 mg/ml) | 10.1 | 10.1 | 0.44 | 0.72 | 1.34 | 5.16 | Substantially EquivalentBelow 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 EquivalentSubject device (Blue and White)having longer permeation thanpredicate (Pink and Green) | |
| Cytarabine(100 mg/ml) | > 240 | > 240 | Not Tested | Additional drug tested for subjectdevice | ||||
| 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 EquivalentSubject device (Blue and White)having longer permeation thanpredicate (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 DeviceK151750 | Predicate DeviceK090412 | Comments | |||||
| Chemotherapy Drugs PermeationTest | Blue | White | Pink | Green | Orange | White | - | |
| Chemotherapy Drugs(Concentration) | MinimumBreakthroughDetection Time inMinutes | Average Breakthrough Detection Time inMinutes | ||||||
| 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 EquivalentSubject device (Blue) at 30.2 minute;Subject device (White) below 30 minutespermeation 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 withCarmustine andThiotepa | WARNING:Notrecommendedfor use withCarmustine andThiotepaCaution: thepermeation timefor Cyclo-phosphamide isonly 55 minutes | WARNING: Notrecommended for usewith Carmustine andThiotepa | Substantially Equivalent | ||||
| Labeling Claim | Tested for Use withChemotherapy Drugs | This Product Does Not Contain Thiuram,and/or Carbamate and/or Thiazole.Low Dermatitis Potential.Tested for Use with ChemotherapyDrugs | Subject device do not have claim ofThis Product Does Not ContainThiuram, and/or Carbamate and/orThiazole. Low Dermatitis Potential |
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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).
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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.
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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.
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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.
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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.
§ 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.