(53 days)
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding "Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove."
This document is a regulatory approval letter, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, which means it has met the regulatory requirements for safety and effectiveness based on comparison to existing devices, rather than through performance in a clinical study with specific acceptance criteria as you've outlined.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, or adjudication methods for a new performance study. The FDA's decision is based on a review of the company's submission, which likely included test methods and results demonstrating the gloves met the protein labeling claim and other general device requirements, but this is not presented as a standalone study report with acceptance criteria in this letter.
Here's why I cannot complete the table or answer the specific questions based on the provided text:
- Acceptance Criteria and Reported Device Performance: This document does not detail specific performance acceptance criteria for a new study. The primary "performance" mentioned is the "Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove," which is a characteristic of the glove rather than a clinical performance metric. The letter indicates the device is "substantially equivalent" to a predicate device, meaning it meets the same safety and efficacy profiles as an already approved device.
- Sample sizes, data provenance, ground truth, adjudication, MRMC study, standalone performance, training set details: These are all aspects of a clinical or performance study report, which is not what this FDA letter is. The letter confirms a regulatory decision, not the details of an independent performance study.
In summary, the provided document is a regulatory approval letter based on substantial equivalence, not a detailed scientific study protocol or results report.
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Image /page/0/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
·Mr. Ngan Boon Seng Director STARMATRIX Sdn. Bhd. 10. Jalan SS 1/26. 47300 Petaling Jaya, Selangor, MALAYSIA
Re: K023977
Trade/Device Name: Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 26, 2002 Received: January 2, 2003
Dear Mr. Seng:
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. Seng
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), please contact the Office of Compliance at (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page of
510(k) Number (if known):_K023977
hite color
PRE-POWDERED LATEX EXAMINATION GLOVES Device Name: PROTEIN LABELING CLAIM ( 100 Mg of less
Indications For Use THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGI NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chiu S. Lim
(Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Dental Devic
510(k) Number: K023927
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter Use
(Optional Formal 1
§ 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.