(249 days)
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No
The 510(k) summary describes examination gloves and their resistance to chemotherapy drugs. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a glove intended to prevent contamination and is not used for treating a disease or condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a condition or disease. Its function is to provide a barrier between the patient and examiner.
No
The device is described as Nitrile Powder Free Examination Gloves, which are a physical, disposable device worn on the hand. The description focuses on material properties and performance against chemotherapy drugs, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use of the Device: The intended use of the Nitrile Powder Free Examination Gloves is clearly stated as: "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 also mentions being tested for use with chemotherapy drugs for protection.
- Mechanism of Action: The device acts as a physical barrier to prevent the transfer of contaminants and to protect the wearer from exposure to certain chemicals. It does not perform any diagnostic tests on biological samples.
The fact that the gloves are tested for use with chemotherapy drugs relates to their protective function and barrier properties, not to any diagnostic capability.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) 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 below:
| Carmustine (3.3 mg/ml) | 5.4 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (20.0 mg/ml) | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25.0 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxe 1 (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 35.2 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
worn on the examiner's hand
Indicated Patient Age Range
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Intended User / Care Setting
medical purpose
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 16, 2018
Hartalega Sdn Bhd % Nural Kong Quality Assurance Senior Manager Hartalega Sdn. Bhd. NO.7. Kawasan Perusahaan Suria Bestari Jaya, 52200 My
Re: K180645
Trade/Device Name: Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: October 19, 2018 Received: October 24, 2018
Dear Nural 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. 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.html; 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 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,
Clarence W. Murray lii III -S
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
Indications for Use
510(k) Number (if known) K180645
Device Name
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
Indications for Use (Describe)
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) 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 below:
| Carmustine (3.3 mg/ml) | 5.4 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (20.0 mg/ml) | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25.0 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxe 1 (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 35.2 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 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) |
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