(66 days)
A 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.
Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber (h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a "Powder-free Barrier-Pro™ Co-Polymer Examination Glove." This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software-as-a-medical-device (SaMD) products.
The 510(k) process for this type of device (a Class I patient examination glove) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, primarily through adherence to general controls (e.g., manufacturing practices, labeling) rather than specific performance metrics derived from clinical studies in the way an AI algorithm would be evaluated.
Therefore, I cannot extract the requested information points because they are not present in this type of regulatory document for this type of medical device.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document states a "substantial equivalence determination" was made, but no specific performance criteria or results are listed.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and not provided. This is a physical medical device (glove), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided. This is a physical medical device.
- The type of ground truth used: Not applicable and not provided.
- The sample size for the training set: Not applicable and not provided.
- How the ground truth for the training set was established: Not applicable and not provided.
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AUG - 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Perusahaan Getah Asas Sdn. Bhd. C/O Mr. James F. Logan Director General Medical Reports Exchange 1301 Defense Highway Gambrills, Maryland 21034
Re: K031625
Trade/Device Name: Powder-free Barrier-Pro™ Co-Polymer Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: 80 LZA Dated: July 24, 2003 Received: July 28, 2003
Dear Mr. Logan:
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. Logan
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 (OS) 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 tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Rutina Creciente for
Susan Runner, DD, MA Interim 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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Rev. 1 . Section 3.
Page 1 of 1
510 (K) Number (if known) :
Devicc Name
・・ー
: Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored
Notc: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber
(h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC
Indications For Use
A patient cxamination 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.
(P).E.A.SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTITIER IPAGE IF NEFDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
SB for Chui lin
(Division
Division of
Infection Contrology General Hospital,
al Devices
510(k) Number. K031625
Prescription Use ( Per 21 CFR 801. 109 ) ાર
Over-The-Counter Use
( Optional Format 1-2-96 )
§ 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.