(46 days)
A Patient Examination Glove 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.
Powderfree Blue Nitrile Examination Gloves (Polymer Coated)
This document is a 510(k) clearance letter from the FDA for "Powderfree Blue Nitrile Examination Gloves (Polymer Coated)". It does not describe a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics like accuracy, sensitivity, specificity, etc., with associated ground truth, expert review, or sample sizes) for an AI/software as a medical device.
The FDA's 510(k) clearance process for this type of device (medical gloves) focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the specific information requested in the format of acceptance criteria and study details for an AI/software device. The document does not contain:
- A table of acceptance criteria and reported device performance: This document does not present performance data like accuracy, sensitivity, or specificity. For gloves, acceptance criteria would typically relate to physical properties (e.g., tensile strength, elongation, puncture resistance) and barrier integrity (e.g., AQL for pinholes), which are not detailed here. The "reported device performance" section is thus not applicable in the context of this document.
- Sample sizes, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or ground truth types for a test set: These are all concepts relevant to performance studies for AI/software devices. This document only states that the device is "substantially equivalent" to predicate devices, implying that its safety and effectiveness are comparable, not that a specific performance study in the AI/software context was conducted.
- Sample size for the training set and how ground truth was established for the training set: These are also concepts for AI/software development and are not part of a 510(k) for medical gloves.
In summary, the provided document is a regulatory clearance for a physical medical device (examination gloves) based on substantial equivalence, not a technical report detailing a performance study for an AI or software device. As such, the specific information requested about acceptance criteria and study details (especially those related to AI/software performance) cannot be extracted from this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot #6, Jalan P/2A, Bangi Industrial Estate 43650 Bandar Baru Bangi Selangor Darul Ehsan Malaysia
Re : K980275 Powderfree Blue Nitrile Examination Trade Name: Gloves (Polymer Coated) Regulatory Class: I Product Code: LZA Dated: January 15, 1998 Received: January 26, 1998
Dear Mr. Lim:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. -- Existing major ----regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Mr. Lim
concerning your device in the Federal Register. Please note: concerning your device in are are the submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic chrough Jr. Or cho novelsions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... ... ... .
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Attachment 8
510(k) number(if known):
Device Name: Powderfree Blue Nitrile Examination Gloves Polymer Coated )
Indications For Use:
A Patient Examination Glove 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)
..
Olin S. Lin
(Division Sign Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
§ 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.