(195 days)
A Latex Powder Free examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient
Latex Powder-Free Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Latex Powder-Free Examination Gloves." It is not a study demonstrating the performance of an AI-powered medical device. Therefore, it does not contain the information requested in the prompt.
The document discusses:
- The FDA's review of a premarket notification (510(k)) for examination gloves.
- The determination of substantial equivalence to legally marketed predicate devices.
- The classification of the device (Class I) and applicable regulations.
- The intended use of the gloves ("worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient").
There is no mention of acceptance criteria for an AI device, study results, sample sizes, expert ground truth, MRMC studies, or training sets for AI.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 1998
MAIKA Rubber Products Sdn. Bhd. C/O Mr. Ravi Anbil Indus Resources, Incorporated 1133 Fairlawn Avenue Libertyville, Illinois 60048
Re: K981942 Latex Powder-Free Examination Gloves Trade Name: Regulatory Class: I Product Code: LYY Dated: October 30, 1998 November 4, 1998 Received:
Dear Mr. Anbil:
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 legally 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
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Page 2 - Mr. Anbil
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 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" (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,
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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Maika Rubber Products Sdn. Bhd. No. 6 Lorong Perak 3 42500 Telok Panglima Garang Kuala Langat, Selangor Malaysia Tel : 603-3527975 Fax : 603-3527893
Indication for Use Statement: 3.0 INDICATION FOR USE Applicant
MAIKA RUBBER PRODUCTS SDN. BHD. No. 6 Lorong Perak 3 42500 Telok Panglima Garang Kuala Langat, Selangor Malayusia
Latex Powder Free Examination Gloves
510(k) Number (if known): Device Name : Indication for Use : 1981942
" A Latex Powder Free examination glove is worn on the
hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient"
Prescription Use __
Over-The-Counter
Per 21 CFR 801.109
(Optional Format 1-2-96)
- for a new submission, do NOT fill in the 510(k) number blank
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .
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§ 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.