(51 days)
This glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
This document is a 510(k) premarket notification letter from the FDA to APL Products Sdn. Bhd. for their "Online Powder Free, Latex Examination Gloves". It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a premarket approval application (PMA). Substantial equivalence is generally based on demonstrating the new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics and performance data to that of the predicate, but the specific acceptance criteria and detailed study results are not provided in this document.
Therefore, I cannot provide the requested information based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human figures embedded within its body. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lee Son Hong Chief Executive Officer APL Products Sdn. Bhd. Lot 8961 & 8964 Jalan Beruas Ayer Tawar, Perak Darul Ridzuan, MALAYSIA 32400
Re: K020865
Trade/Device Name: Online Powder Free, Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 16, 2002 Received: April 22, 2002
Dear Mr. Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Hong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Patricia Cusinitfloe
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 the logo of APL Products Sdn. Bhd. The logo consists of a circular graphic with the letters 'AE' inside, followed by the text 'APL Products Sdn. Bhd.' and the company number '(COMPANY NO.: 241845-A)'. The text is in a bold, sans-serif font.
Lot 8961 & 8964, Batu 19 Jalan Beruas 32400 Ayer Tawar, Perak Darul Riduzuan, Malavsia.
Tel No .: 605-6723152 Fax No .: 605-6726920 E-Mail: sonhong@pc.jaring.my
Indication for Use statement 3.0
: APL Products Sdn. Bhd Applicant
510(k) Number (if know)* :
Device Name : ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
Indication For Use :
This glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
PLESE 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 (Optional Format1-2-96) Over-The-Counter
For a new submission, do NOT fill in the 510(k) number blank.
Qian S. Lin
OR
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K020865
§ 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.