(77 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or cure any condition.
No
Explanation: The device is described as a "single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner." This function is for protection and contamination prevention, not for diagnosing a medical condition.
No
The device is a physical examination glove, not a software application. The description clearly outlines a tangible, disposable product made of nitrile.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the glove is for preventing contamination between the patient and examiner during medical examinations. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics and standards met by the glove, all related to its function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Product codes
LZA
Device Description
White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for the Department of Health & Human Services USA. 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 graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and symbolic, representing the department's role in health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Joseph H. Neuser President Derma Care Plus Products, LLC 2614 Main Street Green Bay, Wisconsin 54311
AUG 2 3 2011
Re: K111589
Trade/Device Name: Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 3, 2011 Received: August 8, 2011
Dear Mr. Neuser:
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
Page 2 – Mr. Neuser
Enclosure
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devi Office of Device Evaluation Center of Devices and Radiological Health
2
K///589
INDICATIONS FOR USE STATEMENT
Applicant: DERMA CARE PLUS PRODUCTS, LLC
Device Name: Powder free Nitrile patient examination glove with colloidal oatmeal USP a skin protectant drug
Classification Name: Glove, Patient Examination, Poly - 80 LZA
Device Description: White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.
Indications For Use: A single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Prescription Use: NO
and /or Over-The-Counter Use: YES
(21 CFR 801 Subpart C)
Eldrett F. Clemens-Williams
(Division Sign Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KI|1589