(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 NITRILE MEDICAL EXAMINATION GLOVE, WHITE COLOR
This document is a 510(k) clearance letter from the FDA for a "Powdered Nitrile Medical Examination Glove, Trade Name: White Color." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
The request asks for information regarding acceptance criteria and a study proving those criteria are met for a device, but the provided document is a regulatory clearance for a nitrile glove. The information typically requested regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies are all relevant to diagnostic or AI/ML-based devices.
Nitrile medical examination gloves are subject to performance standards related to barrier integrity (e.g., freedom from holes), tensile strength, and elongation, which are typically assessed through recognized consensus standards (like ASTM D6319 for nitrile gloves) and not through the kind of studies (e.g., MRMC, expert consensus for ground truth) described in the prompt.
Therefore, the provided document does not contain the type of information requested for a diagnostic or AI/ML device. It focuses on regulatory clearance for a Class I medical device (gloves) based on substantial equivalence to a predicate device, as opposed to performance studies against specific acceptance criteria for complex diagnostic tasks.
To directly answer the prompt based only on the provided context, I would have to state that the requested information is not present. If I were to interpret the "acceptance criteria" through the lens of a regulatory submission for a glove, it would be about meeting recognized standards for physical properties, but the document doesn't detail the study that proves those criteria.
Based on the provided text, I cannot extract the requested information. The document is a 510(k) clearance letter for a medical examination glove, which is a Class I device. The type of detailed performance criteria, study designs (like MRMC, standalone), sample sizes for test/training sets, ground truth establishment, and expert involvement described in the prompt are not applicable or present in this regulatory clearance for a basic medical device like a glove.
The clearance states the device is "substantially equivalent" to predicate devices, meaning it performs as safely and effectively. The "indications for use" provided simply state the glove's purpose: "to prevent contamination between patient and examiner." This does not involve complex performance metrics for diagnostic accuracy.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing right, representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Mr. John Lai Sales Executive Shanqhai Antares Industries, Incorporated No. 259, Yushu Road, Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
K983531 Re: Powdered Nitrile Medical Examination Glove, Trade Name: White Color Requlatory Class: I Product Code: LYZ Dated: June 20, 1998 Received: October 8, 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, Druq, 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 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 Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 obliqation 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 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/dsmamaim.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. ula 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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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use The information, data and labeling claims in the catire the 510(k) submission must suppor agree with the Indications for Use statement.
INDICATIONS FOR USE
12:01
Applicant: SHANGHAI ANTARES INDUSTRIES, INC.
SIO(k) Number (if known): * K983531
Device Name: POWDER NITRILE MEDICAL EXAMINATION GLOVE, WHITE COLOR 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) Concurence of CDRH Office of Device Evaluation (ODE)
Prescription Use OR Per 21 CFR 801 109 (Optional Format 1-2-96)
Over-The-Counter
Olin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
For a new submission, do NOT fill in the 510(k) number blank.
PAGE ADD 3-2
§ 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.