(191 days)
FirstLine Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free – Steel Blue Color) is a disposable patient examination glove that 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.
Double Polymer Coated, Nitrile Examination Gloves (Powder-Free, Non-Sterile, Steel-Blue Color)
This document is an FDA 510(k) clearance letter for Double Polymer Coated, Nitrile Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but it does not provide performance data or details of a study.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2005
Ms. Colette Perches President FirstLine LLC, Incorporated P.O. Box 1628 760 Mcmurray Road Buellton, California 93427
Re: K043149
Ko45147
Trade/Device Name: Double Polymer Coated, Nitrile Examination Gloves (Powder-Free, Non-Sterile, Steel-Blue Color) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 12, 2005 Received: May 16, 2005
Dear Ms. Perches:
We have reviewed your Section 510(k) premarket notification of intent to market the device WC have reviewed your becated the device is substantially equivalent (for the iciclications for use stated in the enclosure) to legally marketed predicate devices marketed in murdions for ass blavior to May 28, 1976, the enactment date of the Medical Device mensiale conments, or to they 22, been reclassified in accordance with the provisions of Amendinents, or to do rose and Cosmetic Act (Act) that do not require approval of a premarket the Fouchal application (PMA). You may, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls providents of the simmal 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 If your device is classified (oos as a vijional controls. Existing major regulations affecting (FMA), it may be subject to tack adam and Federal Regulations, Title 21, Parts 800 to 898. In your device can oe foundsh further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Perches
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 Incall that I DA mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal banner as requirements, including, but not limited to: registration 1 ou inust comply with an are hobeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF rear 807), mailty systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in are qt radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1030. I mis letter will and w Jourse Finding of substantial equivalence of your device to a bromarketed 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), If you desire specific at not to pliance at (240) 276-0115. 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 may obtain 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/industry/support/index.html.
Sincerely yours,
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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K043149
Device Name: _ Double Polymer Coated, Nitrile Examination Gloves (Powder-Free, Non-Sterile, Steel-Blue Color)
Indications For Use:
FirstLine Brand Double Polymer Coated Nitrile Examination Gloves FirstLine Brand Double Forymer Sca disposable patient examination glove
(Powder Free – Steel Blue Color) is a disposable patient examplete provent (Powder Free – Steel Blue Scier) it a display is a similar personnel to prevent contamination between patient and examiner.
Sheila A. Mingshing, MD
Division Sign-Off) (Oivision Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Olvision of Anesonesiones, Intection Control, Devices
510(k) Number: K04314
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.