(67 days)
Not Found
Not Found
No
The device description and intended use clearly define a simple disposable glove, with no mention of AI/ML or related technologies.
No.
The device description and intended use clearly state it is a patient examination glove for preventing contamination, not for treating a condition or disease.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination and is not used to diagnose a medical condition or disease.
No
The device description clearly states it is a "DISPOSABLE VINYL EXAM GLOVES, POWDERED," 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 EXAM GLOVES".
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. The provided information does not mention any such use or analysis of biological specimens.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER: CANAD
Product codes
LYZ
Device Description
DISPOSABLE VINYL EXAM GLOVES,POWDERED
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
Not Found
Intended User / Care Setting
EXAMINER
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
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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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM" on the left side and "SERVICES-USA" on the right side. Inside the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1998
Mr. John Lai ·Sales Executive Shanghai Antares Industries, Incorporated No. 259, Yushu Road, Canqqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
Re : K982687 Disposable Vinyl Exam Gloves, Powdered Trade Name: Regulatory Class: I Product Code: LYZ Dated: July 8, 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 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. 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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Lai
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 labelinq 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" (21 CFR 807.97). Other gener 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
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4
- 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 an agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | SHANGHAI ANTARES INDUSTRIES, INC. |
|---|---|
| 510(k) Number (if known): | K982687 |
| Device Name: | DISPOSABLE VINYL EXAM GLOVES,POWDERED |
| Indications For Use: |
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER: CANAD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Cum
(Division Sign-Off)
Division . i. cial, Infection Control, and General Hospital Devices 510(k) Number
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. 좋
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