(56 days)
Not Found
Not Found
No
The summary describes a standard patient examination glove with no mention of AI/ML features or related data/performance metrics.
No.
The device (patient examination glove) is intended to prevent contamination between the patient and examiner, not to treat a disease or condition.
No
Explanation: The device, a patient examination glove, is primarily intended to prevent contamination between patient and examiner. Its function is not to detect, monitor, or identify a disease, condition, or health status, which are characteristics of a diagnostic device.
No
The device description clearly states it is a physical product (Vinyl Patient Examination Gloves) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination. This is a physical barrier device used during patient examination.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose related to analyzing samples outside the body.
Therefore, the device described is a medical device, but it falls under the category of a physical barrier device for infection control, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
A patient examination glove 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
Vinyl Patient Examination Gloves Powder-Free, Non-Sterile
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purpose
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
Not Found
Key Metrics
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1698
Mr. Chin-Yu Lin ·President Taian Plastic Products (Jingxing) Co., Ltd. The North of Beishimen Village, Xiaozuo Town Jingxing Country, Shijiazhuang City Hebei 050306, CHINA
K982015 Re : Trade Name: Vinyl Patient Examination Gloves Powder-Free, Non-Sterile Requlatory Class: I Product Code: LYZ Dated: May 30, 1998 Received: June 8, 1998
Dear Mr. Lin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. -Existing major ---------------------------------------------------------------------------------------------------------------------regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Lin
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
S. Putnam for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
RODDIC THE NORTH OF BEISHIMEN VILLAGE. XIAOZUO JINGXING COUNTRY. SHIJIAZHUANG CITY HEBEI 050306. CHINA TEL: (86 311) 236-0379, 236-0676, 236-0651 FAX: (86 311) 236-0670, E-MAIL: laian@public.sj.he.cn
Image /page/2/Picture/4 description: The image is a black and white logo inside of a square. The logo is a stylized plant with three leaves. The word "TAIAN" is written vertically down the center of the plant.
INDICATION FOR USE STATEMENT
APPLICANT: Taian Plastic Products (Jingxing) Co., Ltd. પ્રવૃત્ત 510 (K) Number (if known): _ Device Name: Vinyl Patient Examination Gloves- Powder Free
Indication For Use:
A patient examination glove 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.
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign Off)
(Division Sign-Cli Division of Dental. Infection ontrol, and General Hospical Device 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Format 1-2-98)