(39 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Latex Patient Examination Gloves
The provided document is a 510(k) premarket notification for a Powdered Latex Examination Glove. This product is a medical device, but it is not an AI/ML-driven diagnostic or treatment device. The 510(k) clearance process for such a device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the manner of AI/ML algorithms.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document.
The document essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness profile as a device already on the market. The "acceptance criteria" here would be meeting the requirements for substantial equivalence as defined by the FDA.
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Public Health Service
JUL 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
P.T. Anlis Abadi Internasional c/o Mr. Huan-Chung Li Shinemound Enterprise Incorporated 17A Sterling Road North Billerica, Massachusetts 01862
Re: K051465
Trade/Device Name: Powdered Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 20, 2005 Received: June 03, 2005
Dear Mr Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section > ro(x) prematice is substantially equivalent (for the indications felerenced above and nave uctoringed live arketed predicate devices marketed in interstate for use stated in the enclosure) to regars mant date of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enateriance with the provisions of the Federal Food, Drug. devices that have been recaired in accerative while and while and of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarke and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, thanket the device, basyon to the most for annual registration, listing of general controls provisions of the rist 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 il your device is classified (500 above) into existing major regulations affecting your device can may be subject to such additional controlls. Existing and to 898. In addition, FDA may be found in the Oous of concerning your device in the Federal Register.
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Page 2 - Mr. Li
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a bevice complies with other requirements of the Act that FDA has made a decormination an administered by other Federal agencies. You must or any rederal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements) and manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decises vor device as described in your Section 510(k) I his letter will anow you to ogen mailioning of substantial equivalence of your device to a legally premarket nothleadon. The PDA maing of basification 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 If you desire specific advice for your ac 1100 %. Also, please note the regulation entitled, processes of a V contact the Office of Comphalled at (210) and Station" (21CFR Part 807.97). You may obtain " Misoranding by reference to promanto notificas with as the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Auy Sylvom for
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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Attachment B
INDICATION FOR USE
Anwar Firman, P.T. ANLiS INTERNASiONAL. Applicant: 510K Number (if known): * K051465 Device Name: Powdered Latex Patient Examination Gloves Indication For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96) OR
Over – The- Counter Use _X
- For a new submission, do NOT fill in the 510(K) number blank.
Shula R. Murphy, 15
alogy, General Hospital,
510(K) V
§ 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.