(31 days)
A colored, powder free and polymer opated patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be wom on the hands or finger(s) for medical purposes to provide a bantier against potentially mlectious materials and other contaminants. The colors, pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove.
Colored Powder Free And Polymer Ceated Patient Examination Glove (Pink, Blue, Green and Violet) With A Protein Claim Of Less Than 50 pargm Glove.
This FDA clearance letter for the Glovco (M) SDN BHD Colored Powder Free and Polymer Coated Patient Examination Glove (K051345) does not contain the detailed information necessary to answer your questions about acceptance criteria and the specifics of a study proving device performance.
FDA 510(k) clearance letters primarily focus on determining substantial equivalence to a legally marketed predicate device, as opposed to providing in-depth performance study results. The letter confirms that the device is substantially equivalent for its intended use, but it doesn't typically include data tables, sample sizes, expert qualifications, or details about the method by which studies are conducted.
To answer your questions, one would need to review the actual 510(k) submission document (or similar regulatory submission) prepared by Glovco (M) SDN BHD, which would contain the performance summary and supporting data. This letter only provides a summary of the FDA's decision.
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Public Health Service
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the logo.
JUN 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tan Peng Hock Managing Director Glovco (M) SDN BHD Lot 760, Jalan Haji Sirat, 42100 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K051345
Trade/Device Name: Colored Powder Free and Polymer Coated Patient Examination Glove (Pink, Blue, Green and Violet ) With A Protein Claim Of Less Than 50 µg/gm Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 5, 2005 Received: June 1, 2005
Dear Mr. Hock:
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. Hock
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvrsod that 1-27 - 16 lestains on that your device complies with other requirements mean that IDA nas made a decembers and regulations administered by other Federal agencies. of the Act of ally I edelar statutes and registered to: registration 1 ou must comply with an an an an any (21 CFR Part 801); good manufacturing practice allo listing (21 CF re Part 807), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in all quadiation 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) I mis icter will anow your e oogle and of substantial equivalence of your device to a premits in the motion. The PDF 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), II you ucsile specific advise for your 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 other general manufacturers, International and Consumer Assistance at its toll-free Division of 01 01 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syvette Y. Michaud m.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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Indications For Use
K051345 510(k) Number.
Colored Powder Free And Polymer Ceated Patient Examination Device Name: Glove (Pink, Blue, Green and Violet) With A Protein Claim Of Less Than 50 pargm Glove.
A colored, powder free and polymer opated patient examination glove is Indications For Use: a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be wom on the hands or finger(s) for medical purposes to provide a bantier against potentially mlectious materials and other contaminants. The colors, pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove.
Prescription Use NO
AND/OR
Over-The-Counter Use YES (21 CFR 801 Subpan C)
Shula A. Murphy, R.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K051345
§ 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.