(38 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related concepts like image processing or performance studies based on data analysis.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination between patient and examiner. It does not gather information from the patient for the purpose of identifying a disease or condition.
No
The device is a physical glove, not software.
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 "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic testing, or any process that would occur "in vitro" (in glass or outside the body).
Therefore, a patient examination glove, as described, falls under the category of a medical device used for barrier protection during patient contact, not an in vitro diagnostic device.
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- Pre-powdered
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 Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
માણ 3 1098
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
K982257 Re : Vinyl Patient Examination Gloves Trade Name: Pre-Powdered Requlatory Class: I Product Code: LYZ Dated: June 20, 1998 Received: June 26, 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 general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 -----requlations 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 The FDA described in your 510 (k) premarket notification. 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 requlation (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. Sutman 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
TAIAN PLASTIC PRODUCTS (JII THE NORTH OF BEISHIMEN VILLAGE, XIAOZUO TOW JINGXING COUNTRY, SHIJIAZHUANG CITY
Image /page/2/Picture/4 description: The image is a black and white logo. The logo is a stylized plant with three leaves. The word "TAIAN" is written vertically down the center of the plant. The logo is surrounded by a square border.
HEBEI 050306, CHINA TEL: (86 311) 236-0379, 236-0676, 236-0651 E-MAIL: taian@public.sj.he.cn FAX: (86 311) 236-0670,
INDICATION FOR USE STATE
APPLICANT: Taian Plastic Products (Jingxing) Co., Ltd. 510 (K) Number (if known):
Device Name: Vinyl Patient Examination Gloves- Pre-powdered
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)
Otin S. him
(Division Sign-Off) Division of Demal, Infection Control, and General Hospital Devices
510(k) Number K982257
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Format 1-2-96)