(58 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard disposable medical glove, with no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.
No
Explanation: The device is a patient examination glove, described as being worn on the hand or finger to prevent contamination. Its function is protective, not diagnostic.
No
The device description clearly states it is a "DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE," 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 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.
- Device Description: The description confirms it's a "DISPOSABLE VINYL SYNTHETIC EXAM GLOVES".
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically reagents, instruments, or systems used for diagnosis, monitoring, or screening.
The function of an examination glove is to provide a physical barrier, not to perform a diagnostic test on a biological sample.
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
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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
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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
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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
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 two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of a human figure, possibly suggesting care or support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Mr. John Lai Sales Executive Shanghai Antares Industries, Incorporated No. 259, Yushu Road, Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
Re : K982704 Trade Name: Disposable Vinyl Synthetic Medical Gloves, Powder-Free Regulatory Class: I Product Code: LYZ Dated: July 20, 1998 Received: August 3, 1998
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 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 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. ಗಿ 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 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. Lai
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Susa Purser
Timothy A.
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 page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
SHANGHAI ANTARES INDUSTRIES, INC. Applicant: _
5 10(k) Number (if known): * ·K982704 510(k) Number (if known): * * 982704
Device Name: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES , POWDER FREE 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Susa Ran
(Division Sign-Off)
Division of Dental, Infection Соли
and General Hospital Diges
510(k) Number kas 2204
Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96) Over-The-Counter
For a new submission, do NOT fill in the 510(k) number blank.
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