(130 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 per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Not Found
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Patient Examination Gloves, based on the provided document:
Acceptance Criteria and Reported Device Performance
The device, Powder Free Nitrile Patient Examination Gloves (Blue, White, and Black Colored), was tested for permeation by chemotherapy drugs and Fentanyl Citrate according to ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The acceptance criteria are implied to be the reported "Minimum Breakthrough Detection Time in Minutes" for each drug, which the device performance meets or exceeds.
Device Performance Tables:
1. Blue Colored Gloves:
| 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 |
Note: Carmustine (BCNU) has an extremely low permeation time of 10.1 minutes.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
2. White Colored Gloves:
| 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 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 10.1 minutes and 10.4 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
3. Black Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 14.4 |
| 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) | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 14.4 minutes and 29.2 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Study Information:
2. Sample size used for the test set and the data provenance:
- The document implies that the "test set" consists of multiple samples of each glove type (Blue, White, Black) that were subjected to testing against the listed chemotherapy drugs and Fentanyl Citrate.
- The exact sample size (number of gloves or individual tests) is not explicitly stated in the provided text.
- The data provenance is not definitively stated, but it is a premarket notification (510(k)) from a Malaysian company (Kossan International Sdn. Bhd.). It is implied that the testing was conducted to support this submission, likely by or for the manufacturer. The data is retrospective in relation to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves laboratory testing for chemical permeation, not clinical performance or image interpretation requiring expert opinion. The "ground truth" is established by the direct measurement of chemical breakthrough time following the ASTM D6978-05 standard.
4. Adjudication method for the test set:
- This information is not applicable for a laboratory chemical permeation test. The results are quantitative measurements obtained through instrument analysis.
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 as the device is a patient examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical medical glove and does not involve an algorithm. The testing described is for the barrier properties of the glove material.
7. The type of ground truth used:
- The ground truth is based on direct laboratory measurement of chemical permeation/breakthrough time, as defined by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. The sample size for the training set:
- This is not applicable as the study does not involve an algorithm or machine learning that requires a training set. The data presented is the result of direct physical and chemical property testing.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device and study.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 5, 2019
Kossan International Sdn. Bhd. Cho Fong RA Manager Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 3/4, Jalan Kapar Klang, 42100 My
Re: K183287
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, 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, ODO Dated: January 22, 2019 Received: January 24, 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
{1}------------------------------------------------
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 and Part 809); 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 (OS) 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 mediation-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 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K183287
Device Name
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, 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 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.
| Fentanyl Citrate and Concentration |
|---|
| Fentanyl Citrate Injection (100 mcg/2ml) |
Minimum Breakthrough Detection Time in Minutes >240
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.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183287
Device Name
Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, 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 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
Fentanyl Citrate and Concentration Fentanyl Citrate Injection (100 mcg/2ml) Minimum Breakthrough Detection Time in Minutes >240
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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."
ない
{6}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183287
Device Name
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, 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 cherapy drugs and Fentanyl Citrate 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) | 14.4 |
| 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) | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 14.4 minutes and Thiotepa: 29.2 minutes
Fentanyl Citrate and Concentration Fentanyl Citrate Injection (100 mcg/2ml) Minimum Breakthrough Detection Time in Minutes >240
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.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{7}------------------------------------------------
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.