(112 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color
This document is a 510(k) premarket notification letter from the FDA to Platinum Glove Industries Sdn Bhd for their "Smart Savers, Powder Free Nitrile Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
The document does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth, or any other details related to AI/algorithm performance studies. The context of the request is entirely focused on what would be found in a study for an AI-powered medical device, which is not applicable here.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard MAY 1 4 2008 Rockville MD 20850
Ms. So Soon Cheaw General Manager Platinum Glove Industries Sdn Bhd 18-22- 2 Jalan Setia Prima (Q), U13/Q, Sctia Alam U13. Shah Alam, Selangor, MALAYSIA 40170
Re: K080165
Trade/Device Name: Smart Savers, Powder Free Nitrile Examination Gloves, Blue. White, Pink and Gray Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 15, 2008 Received: April 18, 2008
Dear Ms. Cheaw:
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 - Ms. Cheaw
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 (Scctions 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 (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 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/industry/support/index.html.
Sincerely vours.
Ques
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
K080165 510(k) Number (if known):
Device Name: Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color
Indication For Use:
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office Of Device Evaluation (ODE)
Shula H. Murphy, ko
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
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510(k) Number:
§ 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.