(204 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.
Powder - Free Latex Examination Gloves
This letter does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves."
Here's why the information you're looking for is not present in this document:
- 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on a detailed performance study against specific acceptance criteria for a new, innovative device feature.
- Device Type: Examination gloves are Class I devices, which generally have lower regulatory hurdles and do not typically require extensive clinical trials or complex performance studies like those for AI/ML-driven medical devices. Their primary performance metrics relate to barrier integrity, strength, and biological safety.
- Date: This document is from 1997, predating the modern regulatory framework and robust performance study expectations for AI/ML devices.
To provide the information you requested, I would need a document such as:
- A clinical study report for an AI/ML medical device.
- A performance evaluation section from a regulatory submission for a novel AI/ML device.
- A peer-reviewed publication detailing the validation of an AI/ML algorithm.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
.
Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997 Mr. Lim Kuang Sia 'Kossan Latex Industries (M) Snd. Bhd. Lot 16632, 5-1/4 Mile, Jalan Meru, 40150 Klang, 1- Selangor MALAYSIA
K964826 Re: Powder - Free Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: May 20, 1997 Received: May 22, 1997
Dear Mr. Sia:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
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Page 2 - Mr. Sia
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) 594-4618. 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 6389-2041 or at (301) 443-6597.
Sincerely yours,
Watrust
V A. Timoth 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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Page 24 of
510(k) Number (if known):_к 964826
Device Name:Rader____ Free Patient_Bramination 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)
Olin S. him
(Division Sign-Dir Division of Dentsl. Info and General Hospit 51 (Vk) Number
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(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.