(164 days)
Not Found
Not Found
No
The 510(k) summary describes surgical gloves and their testing for chemotherapy drug permeation. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on material properties and drug resistance, not algorithmic performance.
No.
The device (surgical gloves) is intended to prevent cross-contamination, not to treat or cure a disease or condition in a patient.
No
Explanation: The device described is surgical gloves, which are used to prevent cross-contamination. Their function is protective and not to diagnose any condition.
No
The device is described as surgical gloves, which are a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hands of healthcare professionals during surgery to prevent cross-contamination. This is a barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: While "Not Found" is listed, the description of the intended use clearly points to a physical barrier device.
- Mentions image processing, AI, DNN, or ML: None of these are mentioned, which are often associated with more complex diagnostic devices.
- Input Imaging Modality: Not Applicable, further indicating it's not an imaging-based diagnostic.
- Performance Studies: The performance studies focus on the barrier properties against chemotherapy drugs (Breakthrough Detection Time), not on the accuracy of a diagnostic test.
- Key Metrics: The key metric is Breakthrough Detection Time, which relates to the glove's protective function, not diagnostic performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Surgical gloves, while important for patient and healthcare professional safety, do not perform this function.
N/A
Intended Use / Indications for Use
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZA, LZC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals during surgery
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)
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustin (BCNU) | 3.3mg/ml | 8.0 |
| Cisplatin | 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | 16.2 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2017
Top Glove SDN BHD Noor Akilah Bt Saidin Deputy General Manager, OA Lot 4968. Jalan Teratai. Batu 6. Off Jalan Meru Klang, 41050 MY
Re: K171279
Trade/Device Name: Sterile Latex Surgical Powder Free Gloves: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Surgeon's Gloves Regulatory Class: Class I Product Code: KGO, LZA, LZC Dated: September 13, 2017 Received: September 13, 2017
Dear Noor Akilah Bt Saidin:
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 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
1
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 (DICE) 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 (DICE) 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.
Michael J. Ryan -S
for Tina Kiang, PhD 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)
Device Name
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustin (BCNU) | 3.3mg/ml | 8.0 |
| Cisplatin | 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | 16.2 |
- Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 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.
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."
3
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)
Device Name Sterile Latex Surgical Powder Free Gloves
Indications for Use (Describe)
Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
| 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.
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
"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."