(70 days)
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Not Found
No
The summary describes a disposable examination glove and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
A patient examination glove is intended to prevent contamination, not to treat a condition or disease.
No
The device is described as a "patient examination glove" used to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a "DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES," which is a physical hardware device, 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 barrier function, not a diagnostic function.
- Device Description: It's described as a "DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES." This is a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting diseases, or providing information for diagnosis.
- No Mention of IVD-Related Terms: The description does not include terms typically associated with IVDs, such as "assay," "reagent," "analyzer," "diagnostic," or "in vitro."
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform any such function.
N/A
Intended Use / Indications for Use
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER 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
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Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 U.S. Department of Health and Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 9 1999
Mr. John Lai Sales Executive Shanqhai Antares Industries, Inc. No. 259 Yushu Road Canqiao Township Sonqjiang County Shanghai, China, P.R.C.
Re: K993049 Disposable PVC Powdered Synthetic Trade Name: Examination Gloves Requlatory Class: I Product Code: LYZ Auqust 30, 1999 Dated: Received: September 10, 1999
Dear Mr. Lai:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
1
Page 2 - Mr. Lai
the Federal Register. Please note: this response to your ene rederal notification submission does not affect any prematier nocerroacron barunder sections 531 through 542 of obligation you might have ahe Electronic Product Radiation the Act for devioes and ther Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis icceer w=== arrow formarket notification. The FDA described in your 515\n privalence of your device to a legally Finding of bubbeanslasics in a classification for your marketed predicate arits your device to proceed to the market.
If you desire specific advice for your device on our labeling re you debire opeone and additionally 809.10 for in reguladiagnostic 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 Dromocion and advoreze at (301) 594-4639. Also, please note ene orrios or centitled, "Misbranding by reference to che regulacion chorologics, 21 CFR 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/dsmamain.html".
Sincerely yours
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
- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use r The information, data and labeling claims in the entire the 510(k) submission muse support agree with the Indications for Use statement.
INDICATIONS FOR USE
Applicant: ___________________________________________________________________________________________________________________________________________________________________ SHANGHAI ANTARES INDUSTRIES, INC. 510(k) Number (if known): * ___
Device Name: _ DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER 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 OR Over-The-Counter Per 21 CFR 801.109
(Optional Format 1-2-96)
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- For a new submission, do NOT fill in the 510(k) number blank.
Chia S. Lin
- For a new submission, do NOT fill in the 510(k) number blank.
്ലബം of Dental, Infection Cont and General Hospital 510(k) Number