(99 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.
Powdered Latex Examination Gloves
This document is a 510(k) premarket notification approval letter for Powdered Latex Examination Gloves manufactured by Servicom Services Sdn. Bhd. It does not contain information about the acceptance criteria or a study proving device performance as typically expected for medical AI/imaging devices.
Therefore, I cannot extract the requested information. The document is an FDA approval for a physical medical device (gloves), not a software or AI device that would undergo such testing and reporting in a 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and body are formed by the silhouettes of the human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 1998
Mr. N.S. Kumar Quality Control Manager Servicom Services Sdn. Bhd. Suite GH 17th Floor Banqunan Angkasa Raya Jalan Ampanq 50450 Kuala Lumpur, MALAYSIA
K980611 Re : Powdered Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: March 9, 1998 Received: March 13, 1998
Dear Mr. Kumar:
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 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. ದ 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. Kumar
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 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" (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.fdb.gov/cdrh/dsmamain.html".
Sincerely yours,
ny A. Ulatowski Timot Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "SERVICOM" in a bold, sans-serif font. The text is white and stands out against a black background. The letters are evenly spaced and fill the rectangular frame of the image.
Suite GH 17th Floor Tel : 603-244 6 Bangunan Angkasa Raya : 603-248 9 Jalan Ampang 50450 Fax : 603-244 6. Kuala Lumpur, Malaysia. : 603-245 2
INDICATIONS FOR USE
Applicant
SERVICOM SERVICES SDN BHD
510(k) number
Device Name
ared and Patient Examination Gloves
Indication for Use :-
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient.
It is a single use disposable gloves.
(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
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.