(97 days)
Not Found
Not Found
No
The device is a glove and the summary describes testing for chemotherapy drug resistance, with no mention of AI or ML.
No
The device is a glove for examination and protection, not for treating a disease or condition. Its purpose is to prevent contamination and protect the examiner's hand from chemotherapy drugs.
No
This device is a non-sterile disposable glove intended to prevent contamination and is tested for use with chemotherapy drugs, not for diagnosing medical conditions.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purpose that is worn on the examiner's hand".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner." This describes a barrier device used externally on the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description confirms it's a glove worn on the hand.
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVDs. The testing mentioned is for resistance to chemotherapy drugs, which is a performance characteristic of the glove as a barrier, not a diagnostic test.
Therefore, this device falls under the category of a medical device, specifically a personal protective equipment (PPE) and barrier device, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is non -sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
worn on the examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for use with chemotherapy drugs, and breakthrough times were reported for various drugs. For Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue): Carmustine: 0.1 minutes, Thiotepa: 20.4 minutes. For Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange): Carmustine: 20.3 minutes, Thiotepa: 50.6 minutes. For Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White): Carmustine: 20.4 minutes, Thiotepa: 71.0 minutes. Most other listed chemotherapy drugs showed breakthrough times of >240 minutes for all three glove colors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough time (minutes) for various chemotherapy drugs.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2015
Hartalega NGC Sdn Bhd Nurul Aisyah Kong Senior Manager-quality Assurance C-G-9, Jalan Dataran SD1 Dataran SD PJU 9 Bandar Sri Damansara Kuala Lumpur 52200 Malaysia
Re: K151343
Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: July 15, 2015 Received: July 20, 2015
Dear Ms. Aisyah Kong:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151343
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
| Chemotherapy Drugs | Concentration (mg/ml) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine | 3.3 | 0.1 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide | 20.0 | >240 |
| Fluoroucil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin | 0.5 | >240 |
| Paclitaxel | 6.0 | >240 |
| Thiotepa | 10.0 | 20.4 |
| Vincristine Sulfate | 1.0 | >240 |
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 0.1 and 20.4 minutes respectively.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
서 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 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."
4
Indications for Use
510(k) Number (if known) K151343
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
| Chemotherapy Drugs | Concentration (mg/ml) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine | 3.3 | 20.3 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide | 20.0 | >240 |
| Fluoroucil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin | 0.5 | >240 |
| Paclitaxel | 6.0 | >240 |
| Thiotepa | 10.0 | 50.6 |
| Vincristine Sulfate | 1.0 | >240 |
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.3 and 50.6 minutes respectively.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
서 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Indications for Use
510(k) Number (if known) K151343
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is non -sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
| Chemotherapy Drugs | Concentration (mg/ml) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine | 3.3 | 20.4 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide | 20.0 | >240 |
| Fluoroucil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin | 0.5 | >240 |
| Paclitaxel | 6.0 | >240 |
| Thiotepa | 10.0 | 71.0 |
| Vincristine Sulfate | 1.0 | >240 |
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.4 and 71.0 minutes respectively.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
서 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."