(171 days)
The Powder Free Patient Examination Gloves is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potential infectious materials and other contaminants.
Powder Free Latex Examination Gloves
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) substantial equivalence letter for "Powder Free Latex Examination Gloves" and does not contain information about specific performance acceptance criteria or details of a study conducted to demonstrate the device meets such criteria.
The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. It does not include efficacy or performance study details.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2003
Tan Sin Lian Industries Sdn. Bhd. C/O Mr. Lee Tan President Wimex, Incorporated 1133 North 4th Street Philadelphia, Pennsylvania 19123
Re: K031335
Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 17, 2003 Received: July 28, 2003
Dear Mr. Tan:
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. Tan
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 annlicable, 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.
Susan Ruiner
Chia-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K031335 |
|---|---|
| Device Name: | Powder Free Patient Examination Gloves |
| Indication for Use: | The Powder Free Patient Examination Gloves is adisposable device made of natural rubber latex that may bear atrace amount of glove powder and is intended to be worn onthe hand for medical purposes to provide a barrier againstpotential infectious materials and other contaminants. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Day, Interim Branch
(Division Sign-Off) Chief. 10/16/
Division of Dental, Infection Control and General Hospital Devices
510(k) Number K031335
Prescription Use (Per 21 CFR 801.109) 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.