(50 days)
A 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.
Chlorinated, Polymer-Coated , Powder-free , Latex Patient Examination Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding a Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove. This document approves the device for marketing based on its substantial equivalence to legally marketed predicate devices.
The information you are requesting about acceptance criteria and study details (such as sample size, ground truth, expert qualifications, adjudication methods, and MRMC studies) is typically found in the device's 510(k) summary or a more detailed submission document, not in the approval letter itself. The approval letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent, implying that the submitted data met the necessary criteria for equivalence.
Therefore,based on the provided document, I cannot fulfill your request for the following reasons:
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No Acceptance Criteria or Performance Data: The letter does not specify any quantitative acceptance criteria or report device performance metrics (e.g., sensitivity, specificity, accuracy, or physical property measurements like tensile strength, elongation, or barrier integrity for a glove). It states that the device is "substantially equivalent," which means it performs as safely and effectively as a predicate device, but the specific metrics used for that determination are not detailed here.
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No Study Details: The letter does not include information about:
- Sample sizes used for testing.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance (this device is a physical medical glove, not an AI algorithm).
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
In summary, the provided document is an FDA approval letter for a medical glove, not a detailed technical report or study summary. Therefore, it does not contain the information requested about acceptance criteria and study specifics.
To obtain this information, one would typically need to consult the full 510(k) submission document or summary, which may be available through the FDA's public databases.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The logo is printed in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Mr. Bob Chan General Manager Perusahaan Getah Asas Sdn. Bhd. Lot 754, Jalan Haji Sirat, Off Jalan Kapar, P.O. Box 188, 41720 Klang, Selangor Darul Ehsan, MALAYSIA
Re : K982806 Trade Name: Chlorinated. Polymer Coated, Powder-Free Latex Examination Glove Regulatory Class: I Product Code: LYY Dated: August 6, 1998 Received: Auqust 11, 1998
Dear Mr. Chan:
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 leqally 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. ਬੋ 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 requlatory 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
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Page 2 - Mr. Chan
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 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,
Susan Hamm
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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Section 3
Page 1 of 1
510 (K) Number (if known) : K982806
Device Name
:
: Chlorinated, Polymer-Coated , Powder-free , Latex Patient Examination Glove
Indications For Use
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suver
(Division Sign-Citi Division of T) . . . ntrol, and General **
510(k) Number Kad886
Prescription Use ( Per 21 CFR 801. 109 )
OR
Over-The-Counter Use
( Optional Format 1-2-96 )
§ 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.