(90 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Natural Latex Examination Glove with Protein Content labeling claim 137 micrograms or less
The provided document is a 510(k) premarket notification letter from the FDA for "Health-Plus, Sanitex, Reliance Pre-Powdered Latex Examination Gloves with Protein Labeling Claim (137 Micrograms or Less)." This document is a clearance letter for a medical device (latex examination gloves) and not a study report for a diagnostic AI device. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or adjudication methods typically found in studies for AI-powered medical devices.
The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to an existing device, rather than a clinical study establishing novel performance metrics or AI capabilities.
Given the nature of the document, the requested information about acceptance criteria and a study proving the device meets them cannot be extracted.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they also resemble a bird in flight. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 9 1999
Mr. Said Awanq Product Development & Technical QA Pamitex Industries SDN. BHD. 2½ Miles, Jalan Rasah 70300 Seremban Negeri Sembilan Darul Khusus MALAYSIA
K991969 Re : Health-Plus, Sanitex, Reliance Pre-Powdered Trade Name: Latex Examination Gloves with Protein Labeling Claim (137 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: June 2, 1999 Received: July 11, 1999
Dear Mr. Awang:
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 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 regulations affecting your device can be found in the Code of Title 21, Parts 800 to 895. Federal Regulations, 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
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Page 2 - Mr. Awanq
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in jour in jour lence of your device to a legally marketed predicate device results in a classification for your markets production of mits 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" (21 CFR 807.97). Other general 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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510(k) Number (if known): --------------------------------------------------------------------------------------------------
Device Name: Natural Latex Examination Glove with Protein Content labeling claim 137 micrograms or less
Indications For Use:
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ---------------------------(Per 21 CFR 801.109)
Over The Counter Use --OR (Optional Format 1-2-95)
Qhis S. Lin
ision Sign-Off) Division of Dental, Infection Control, and General Hospital Device
510(k) Number K991969
§ 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.