(19 days)
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Not Found
No
The summary describes a simple, disposable medical device (examination gloves) with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
Explanation: The device is a "patient examination glove" intended to prevent contamination between the patient and examiner. Its purpose is protective, not diagnostic.
No
The device description clearly states it is "Powdered Vinyl Patient Examination Gloves," which are a physical hardware product, 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 hand or finger. 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 devices used to perform tests on samples taken from the human body to provide information about a person's health. Patient examination gloves do not perform such tests.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYZ
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
hand or finger
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2004
Zibo Borui Plastic & Rubber Products Company Limited C/O Mr. Huan-Chung Li Shinemound Enterprise, Incorporated 17A Sterling Road North Billerica, Massachusetts 01862
Re: K040828
Trade/Device Name: Disposable Powdered Vinyl Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 18, 2003 Received: March 31,2004
Dear Mr. Li:
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 inclications 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.
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 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.
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Page 2 -Mr. Li
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance at (301) 594-4613. 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 Division 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/dsma/dsmamain.html
Sincerely vours,
Kein Muluy
Son 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
Enclosure
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Attachment B
INDICATION FOR USE
Liu Yun Lang, Zibo Borui Plastics & Rubber Co., Ltd.
(if known): Applicant: 510K Number (if known): Device Name: Powdered Vinyl Patient Examination Gloves Indication For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martha T. O'Lone
(Division Sign-Off) Dr. INCB Branch Chief
Division of Anesthesiology/General Hospital
Infection Control, D 510(k) Number: