(413 days)
A 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.
Powder-Free Latex Examination Gloves
This document is a 510(k) clearance letter from the FDA for Powder-Free Latex Examination Gloves. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on demonstrating equivalence through comparison to an existing device, rather than requiring new clinical studies to establish performance against defined acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document indicates that the device is "substantially equivalent" to devices marketed prior to May 28, 1976, and outlines general regulatory compliance rather than specific performance metrics or studies.
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JUN 1 6 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yunus Latif Felda Rubber Industries SDN BHD Head Office 7th Floor, Balai Felda Jalan Gurney 1 Kuala Lumpur, Malaysia 体
K961634 Re : Powder-Free Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: April 10, 1997 Received: April 15, 1997
Dear Mr. Latif:
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, qood 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 requlations affectinq 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Mr. Latif
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 mequlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 requlation 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 at (301) 443-6597.
Sincerely yours,
Alitorist
Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices
market the aevice, supject to finelai controlle provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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INDICATIONS FOR USE
Applicant : Felda Rubber Industries Sdn Bhd
510(k) Number (if known) : K96 | 6 34
Device Name : _ Powder Free Latex Examination Gloves
Indications For use :
参
A 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.
(PLEASE DO NOT WRITE BELEOW THIS LINE - CONTINUE ON ANOTHER FACE - IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Clint Sitton
Division Sign-Off
(Division Sign Division of Dental, Inst and Ganeral Hosp 510(k) Number
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.