(378 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, an examination glove, is intended for preventing contamination, not for treating a disease or condition in a therapeutic manner.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device description clearly states it is a physical product (gloves) and there is no mention of software components or functions.
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.
- 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.)
- Providing information about a patient's health status, diagnosis, or disease
- Using reagents or other chemical processes
- Performing tests outside of the body (in vitro)
The device is a medical device, but its function is a physical barrier for protection, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LYZ
Device Description
Not Found
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three curved lines, possibly representing a stylized human figure or a symbol of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1999
Shanghai Jiatai Plastic Products Company, Limited c/o Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, NY 89434-9550
Re : K983613
Trade Name: Pre-Powdered Non-Sterile Vinyl Examination Gloves Requlatory Class: I Product Code: LYZ Dated: October 4, 1999 Received: October 8, 1999
Dear Ms. Tucker:
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 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Eederal Register. Please note: this response to your premarket notification submission does not affect any
1
Page 2 - Ms. Tucker
obligation you might have under sections 531 through 542 of obligation you might have ahe Electronic Product Radiation the Act for devices ander enderal laws or regulations.
This letter will allow you to begin marketing your device as Info Iceeer will areas) premarket notification. The FDA described in your sisting prour device of your device to a legally marketed predicate device results in a classification for your marketed predicate device rusales in the to proceed to the market.
If you desire specific advice for your device on our labeling II you debite operile additionally 809.10 for in regulation (21 ellevices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (301) 304 1532. Fishing of your device, please contact the promocion and advercibing or just 1639. Also, please note the office of Compriance at (30anding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsibiliation of Small Manufacturers Assistance obtained Trom the Division of Bilard (300) 443-659) or at at its coll free namber (0)//www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Ulatowski Directør Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
$\frac{6}{16}$
1983613 510(k) NUMBER (IF KNOWN) :
DEVICE NAME: Jiatai Synthetic Vinyl Exam Gloves, Powdered, USP
INDICATIONS FOR USE:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use X
(Optional Format 1-2-96)
Clim S. lir
(Civision Sign-Off) Proision of Dental, Infection Control, and General Hospital D 51000) Number