(63 days)
Not Found
Not Found
No
The summary describes a simple disposable glove and explicitly states that AI, DNN, or ML were not found.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, primarily for barrier protection, not for treating or diagnosing a medical condition.
No
Explanation: The device is a glove worn by an examiner to prevent contamination, not to diagnose a condition or disease.
No
The device is described as a physical glove worn on the hand, which is a hardware component, 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 to prevent contamination between patient and examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a glove, a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests in vitro (outside the body) on samples to gain information about a patient's health status. This device is used in vivo (on the body, specifically the examiner's hand) as a protective barrier.
N/A
Intended Use / Indications for Use
A patient examination Vinyl Powdered Gloves is a disposable A patient chamilable medical purpose that is worn on the device Intended for media. Contamination between patient and examiner.
Product codes
LYZ
Device Description
Powdered Vinyl Examination Glove
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)
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
DEC 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. K.M. Lee Executive Director Great Glove (China) Incorporated 3-4 Floor, No.16 Hua Chang Road Jiangsu 215600, Zhangjiagang CHINA
Re: K052922
Trade/Device Name: Powdered Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 7, 2005 Received: December 13, 2005
Dear Mr. Lee:
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 approvisions 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), it hay ob back 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. Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of advisod that 127 to leasiness on that your device complies with other requirements moun that I DAT has made a actes and regulations administered by other Federal agencies. or the Act of any vouth all the Act's requirements, including, but not limited to: registration 1 od intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quartify ajon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter while are in J The FDA finding of substantial equivalence of your device to a premaired predicated. - In a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific acerof Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syrtie y. Michie Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known): K052922
Device Name: Powdered Vinyl Examination Glove
a manager and the comments of the comments of the comments of the comments of the comments of the comments of the former of the former of the former of the former of the form
Indications For Use:
A patient examination Vinyl Powdered Gloves is a disposable A patient chamilable medical purpose that is worn on the device Intended for media. Contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murray D 12/20/05
School, Dental Devices
K-052922
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