(162 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.
Pre-powdered Multi-ply Examination Glove (Natural Latex Laminated with Nitrile, Externally and Internally)
This document is a 510(k) clearance letter from the FDA for a medical device (multi-ply examination gloves). It states that the device is substantially equivalent to a pre-existing device and can be marketed. However, this letter does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a test set, experts, adjudication, MRMC studies, standalone performance, ground truth establishment, or training sets.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory communication, not a performance study report.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human figures, possibly symbolizing health and well-being. The text is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT 6 1999
Mr. Azman Ismail Production Manaqer Pamitex Industries SDN. BHD. Batu 2½ Miles, Jalan Rasah 70300 Seremban Negeri Sembilan Darul Khusus MALAYSIA
K991474 Re : Health-Plus, Sanitex and Reliance Multi-Ply Trade Name: Pre-Powdered Examination Glove (Natural) Latex Laminated with Nitrile, Externally and Internally) Regulatory Class: I Product Code: LYY September 1, 1999 Dated: Received: September 10, 1999
Dear Mr. Ismail:
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 reguirements 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. ਜ 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. Ismail
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" (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.fpa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr 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): K 991474
Device Name: Pre-powdered Multi-ply Examination Glove (Natural Latex Laminated with Nitrile, Externally and Internally) 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 ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clus hin
(Division Sign-Off)
ion of Dental, Infection Control, and General Hospital Devices
510(k) Number K991474
Prescription Use (Pcr 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.