(81 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 and Fentanyl Citrate 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, Black Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document describes the acceptance criteria and the study results for Kossan International Sdn. Bhd.'s Powder Free Nitrile Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on their resistance to permeation by chemotherapy drugs and Fentanyl Citrate, as determined by ASTM D6978-05 (Reapproved 2013). The reported device performance is the "Minimum Breakthrough Detection Time in Minutes" for each substance.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | (Not explicitly defined, but a longer time is better) | 25.2 |
| Cisplatin (1.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Cytarabine (100 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Etoposide (20.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Fluorouracil (50.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Ifosfamide (50.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Methotrexate (25.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Mitomycin C (0.5 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Mitoxantrone (2.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Thiotepa (10.0 mg/ml) | (Not explicitly defined, but a longer time is better) | 35.9 |
| Vincristine Sulfate (1.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Simulated Gastric Acid Fluid | (Not explicitly defined, but a longer time is better) | >240 |
Note: While specific numerical "acceptance criteria" are not explicitly stated as pass/fail thresholds in the document for each drug, the implication of conducting the test and reporting breakthrough times is that these values met the manufacturer's internal standards and/or the expectations for substantial equivalence based on the ASTM D6978-05 standard. The goal is to maximize the breakthrough time for safety.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size (number of gloves or trials) used for the permeation tests. It only states that the gloves "were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." Following an ASTM standard typically implies a specific number of replicates, but this detail is not provided.
The data provenance is from prospective testing conducted by the manufacturer according to the specified ASTM standard. The country of origin of the data is not explicitly stated, but the manufacturer, Kossan International Sdn. Bhd., is based in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The "ground truth" for glove permeation is established by objective laboratory measurements using analytical techniques to detect the breakthrough of chemical substances, not by expert interpretation.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For a technical performance test like chemical permeation, the results are objective measurements.
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 is not applicable. This document pertains to the performance of examination gloves against chemical permeation, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document pertains to the performance of examination gloves against chemical permeation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is objective laboratory measurement (detection of chemical permeation through the glove material) based on the methodology outlined in ASTM D6978-05.
8. The sample size for the training set
This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above (physical product, no training set).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2019
Kossan International Sdn. Bhd. Cho Fong RA Manager Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 34, Jalan Kapar, 42100 Klang, Selagor, Malaysia
Re: K190606
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC, QDO Dated: March 5, 2019 Received: March 8, 2019
Dear Cho 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Actin Division Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K190606
Device Name
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
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 and Fentanyl Citrate 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) | 25.2 |
| 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) | 35.9 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 25.2 and 35.9 minutes respectively.
| Fentanyl Citrate and Concentration |
|---|
| Fentanyl Citrate Injection (100 mcg/2ml) |
Simulated Gastric Acid Fluid
Minimum Breakthrough Detection Time in Minutes >240
Minimum Breakthrough Detection Time in Minutes >240
Type of Use (Select one or both, as applicable)
Simulated Gastric Acid Fluid
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.
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{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."
§ 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.