(53 days)
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.
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLOR (BLUE COLOR)
This document is a 510(k) clearance letter for a medical device: "Powder-Free Copolymer Nitrile Medical Examination Glove, Blue Color". As such, it is not a study report or clinical trial document that would typically contain the detailed information requested regarding acceptance criteria and device performance studies for AI/ML devices.
The information provided pertains to the regulatory clearance of a physical medical device (gloves) and focuses on substantial equivalence to a predicate device, not on the performance metrics of a diagnostic algorithm or an AI system.
Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document as it is not relevant to the subject matter.
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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
NOV 30 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Lai Sales Executive Shanghai Antares Industries, Incorporated No. 259, Yushu Road, Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
Re : K983532 Powder-Free Copolymer Nitrile Medical Trade Name: Examination Glove, Blue Color Regulatory Class: I Product Code: LYZ June 8, 1998 Dated: October 8, 1998 Received:
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 reguirements 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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
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Page 2 - Mr. Lai
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 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 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 requlation 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,
Timothy A. Ulatowski
Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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06-NOV-1998 21:52
- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. Indications for Use Statement: Include interest The unomaton, can ications for Use statement.
INDICATIONS FOR USE
| INDICATIONS FOR USE | |
|---|---|
| --------------------- | -- |
| Applicant: | SHANGHAI ANTARES INDUSTRIES, INC. |
|---|---|
| 510(k) Number (if known): | K983532 |
| Device Name: | POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLOR |
| Indications For Use: | (BLUE COLOR) |
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)
Olin S. Lin
(Division Sign-Off)
Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983532
Prescription Use OR Per 21 CFR 801.109 (Optional Formal 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank. .
Over-The-Counte
PAGE ADD 3-1
§ 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.