(65 days)
Patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prepowdered Latex Examination Glove - Blue color
This document is a 510(k) clearance letter from the FDA for a patient latex examination glove. It does not contain information about the acceptance criteria or a study proving that a device meets the acceptance criteria. Therefore, I cannot fulfill your request based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 1998
Mr. Azman Ismail PWA Industries Sdn. Bhd. Lot 93, Semambu Industrial, Estate 25350, Kuantan, Pahang MALAYSIA
Re : K981774 Patient Latex Examination Glove, Blue Color Trade Name: Requlatory Class: I Product Code: אציו Dated: June 25, 1998 Received: July 6, 1998
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 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 regulations affecting 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Ismail
through 542 of the Act for devices under the Electronic enrough Siz of on 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 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" (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,
S. Dutton
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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Image /page/2/Picture/0 description: The image shows a logo with the letters "PWA" in a stylized, geometric font. The "P" is designed with a maze-like pattern within its shape. The "W" is formed by two intersecting "V" shapes, and the "A" is a triangle with a horizontal line extending from its right side. The logo is black and appears to be printed on a white background, though the image quality is somewhat degraded with visible noise and artifacts.
Lot 93, Semambu Industrial Estate, 25350 Kuantan, Pahang, Tel: 09-5670835, 5670836, 5670837 Fax: 09-5670839
4.0 AN INDICATION FOR USE STATEMENT
March 10, 1998
Center for Devices and Radiological Health Food and Drug Administration 1390, Piccard Drive r Rockville, Maryland 20850 USA
510(k): K981774
Prepowdered Latex Examination Glove - Blue color
Sub : An Indication for Use Statement
Patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
(Division Sign-೧೯೧ Division of Donni, Jafecia - Hontrol, and General time Jial De 510(k) Number
§ 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.