(227 days)
Not Found
Not Found
No
The device is a medical 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 a glove intended to prevent contamination between patient and examiner, which is a protective rather than a therapeutic function.
No
The device is a non-sterile disposable glove worn by an examiner to prevent contamination and has been tested for resistance to chemotherapy drugs. It does not perform any diagnostic function.
No
The device is described as a "non-sterile disposable device intended for medical purpose that is worn on the examiner's hand," which is a physical glove, 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 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." This describes a barrier device used for protection during physical examination or procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as 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.
- Lack of Diagnostic Function: The description and intended use do not mention any diagnostic function. The device does not analyze samples from the body or provide information about a patient's health status. Its purpose is purely protective.
- Testing for Chemotherapy Resistance: While the device is tested for resistance to chemotherapy drugs, this testing relates to its barrier properties and safety for the user when handling these substances, not to a diagnostic application.
In summary, the device is a medical glove intended for barrier protection, not for performing diagnostic tests on patient samples. Therefore, it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
Carmustine (3.3 mg/ml) - 10.1 minutes
Cisplatin (1.0 mg/ml) - >240 minutes
Cyclophosphamide (20 mg/ml) - >240 minutes
Dacarbazine (10.1 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 mg/ml) - >240 minutes
Mitomycin C (0.5 mg/ml) - >240 minutes
Paclitaxel (6.0 mg/ml) - >240 minutes
Thiotepa (10.0 mg/ml) - 30.4 minutes
Vincristine Sulfate (1.0 mg/ml) - >240 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Breakthrough times for various chemotherapy drugs are listed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough times (minutes) for various chemotherapy drugs (e.g., Carmustine: 10.1 minutes, Cisplatin: >240 minutes, Thiotepa: 30.4 minutes).
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 features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2016
Hartalega Sdn. Bhd. Mr. H. Carl Jenkins Regulatory Counsel to Hartalega Sdn. Bhd. 10 E. Scranton Ave. Suite 201 Lake Bluff, IL 60044
Re: K160562
Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 7, 2016 Received: September 9, 2016
Dear Mr. Jenkins:
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 yours.
Michael J. Ryan -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) K160562
Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
| Carmustine (3.3 mg/ml) | 10.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Dacarbazine (10.1 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 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Paclitaxel (6.0 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 30.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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