(173 days)
Latex Examination Glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Latex Examination Gloves (Powdered)
The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves (Powdered)". This type of document is a regulatory approval for a medical device and does not contain the detailed technical study information that would describe acceptance criteria and device performance in the way requested for AI/ML or diagnostic devices.
Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these types of studies are not typically conducted or reported in a 510(k) summary for general-purpose physical devices like examination gloves. The 510(k) pathway for such devices primarily focuses on demonstrating substantial equivalence to a predicate device, often through engineering specifications, material properties, and basic performance tests (e.g., integrity, strength), rather than clinical performance metrics that would involve complex statistical analyses and expert adjudication.
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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 a stylized eagle or bird symbol, composed of three curved lines that suggest wings or feathers. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the bird symbol placed centrally below the text.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1999
Mr. Kuan Teck Director Sama Kejuruteraan Sdn. Bhd. Lot 1807, Jalan Balakong, Taman Bukit Belimbing, 43300 Balakong, Selangor, Darul Ehsan, MALAYSIA
Re : K984229 Trade Name: Latex Examination Gloves (Powdered) Requlatory Class: I Product Code: LYY Dated: April 14, 1999 April 22, 1999 Received:
Dear Mr. Kuan Teck:
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 of the Act. The general controls provisions 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 Federal Requlations, Title 21, Parts 800 to 895. ಗೆ 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 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Kuan Teck
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 labelinq 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" (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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/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 Radioloqical Health
Enclosure
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- Indications for Uses: Include the following or equivalent "Indications For Use" page th: 3.0 contains the applicants name, name of the device and the intended use of the device. Th information, data and labeling claims in the entire the 510(k) submission must support an agree with the "indication for use" statement.
- For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: SAMA KEJURUTERAAN SDN. BHD.
K984229 * 510(k) Number (if known): __
Device Name: Latex Examination Gloves (Powdered)
Indications For Use:
ਾ ਸਿੰਘ
Latex Examination Glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrent of CDRH Office of Device Evaluation (ODE)
Sian a In Olin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K98 4 22 9
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
(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.