(47 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.
Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)
This document is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)."
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is an approval letter for a medical device (patient examination gloves), confirming that the device is substantially equivalent to legally marketed predicate devices. The letter primarily details the regulatory classification, general controls, and compliance requirements for the manufacturer.
Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 2 5 2002
Mr. Liew Yoon Fong Executive Director Purnabina Sdn. Bhd. Plo5, Jalan Mahsuri 1, 7.5KM Jalan Mersing, Kawasan Perindustrian Kluang 86007 Kluang, Johor, MALAYSIA
Re: K022659
Trade/Device Name: Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 5, 2002 Received: August 9, 2002
Dear Mr. Fong:
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 vour 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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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,
Timothy A. Uhlmann
Timothy A. Ulatowski 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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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | Purnabina Sdn. Bhd. |
|---|---|
| 510(k) Number (if known): * | K022659 |
| Device Name: | Patient Examination Glove |
| Indications For Use: |
A patient examination glove is a disposable device intended for medical A pactent chamination goothe examiner's hands or finger to prevent purposes that between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96)
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- For a new submission, do NOT fill in the 510(k) number blank.
Olim S. Lion
- For a new submission, do NOT fill in the 510(k) number blank.
f Anesthesiology, General Hospital,
510(k) Number. K022659
§ 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.