(98 days)
Not Found
Not Found
No
The device is a glove and the description focuses on its material properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No
The device is an examination glove, which is intended to prevent contamination between patient and examiner, not to provide therapy.
No
The device, Nitrile Powder Free Examination Gloves, is described as a non-sterile disposable device worn on the examiner's hand to prevent contamination and is tested for use against chemotherapy drugs. Its purpose is protective and preventive, not to diagnose a medical condition or disease.
No
The device is described as "Nitrile Powder Free Examination Gloves," which are physical, tangible items. The description focuses on their material, color, and testing against chemotherapy drugs, all indicative of a hardware device. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a glove worn on the examiner's hand to prevent contamination. Its primary function is a physical barrier.
- Intended Use: The intended use is for medical purposes as a barrier and for protection against chemotherapy drugs. This is a protective function, not a diagnostic one.
- Lack of Diagnostic Activity: The device does not analyze biological samples or provide information about a patient's health status. The testing against chemotherapy drugs is about the glove's barrier properties, not about diagnosing anything in a patient.
Therefore, based on the provided information, this device falls under the category of a medical device, specifically a protective barrier, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is a 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 - Dark Violet Blue (DVBU) is a 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 Nitile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU) is a 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.
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
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)
Not Found
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
§ 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 & 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 an abstract symbol that resembles a stylized human figure or a caduceus, composed of three interconnected lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
Hartalega Sdb. Bhd. Nurual Kong Quality Assurance Senior Manager No.7, Kawasan Perusahaan Suria Bestari Jaya, 45600 MY
Re: K162924
Trade/Device Name: Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated December 14, 2016 Received: December 19, 2016
Dear Nurual 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.
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 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Division Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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 a 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 Chemotheray Drugs (tered with breakthrough times) is as per below table.
The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 15.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
- Please note that the following drugs have extremely low permeation times of 15.1 minutes with Carmustine (3.3 mg/ml) and 15.4 minutes with Thiotepa (10.0 mg/ml).
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.
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 annound the and review the collection of information. Send comments regarding this burden estimate or any other onpect 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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
3
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
De not Nemo
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Violet Blue (DVBU) is a 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) is as per below table.
The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 46.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
- Please note that the following drugs have extremely low perneation times of 15.1 minutes with Carmustine (3.3 mg/ml) and 46.4 minutes with Thiotepa (10.0 mg/ml).
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.
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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
4
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
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU)
Indications for Use (Describe)
The Nitile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU) is a 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) is as per below table.
The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:
| Carmustine (BCNU) (3.3 mg/ml) | 1.7 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 10.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
- Please note that the following drugs have extremely low permeation times of 1.7 minutes with Carmustine (3.3 mg/ml) and 10.8 minutes with Thiotepa (10.0 mg/ml).
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.
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 spect 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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF