(73 days)
A medical giove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILON CORRECT-TOUCH POWDERED NITRILE Examination Glove
Here's an analysis of the provided text regarding acceptance criteria and study details for the Nitrilon™ Correct-Touch® Powdered Nitrile Examination Gloves:
Important Note: The provided document is a 510(k) clearance letter from the FDA for medical gloves. This type of document declares substantial equivalence to a previously marketed device, rather than providing a detailed study report with specific performance metrics and acceptance criteria as would be found for a novel AI device or a more complex medical device requiring clinical trial data.
Therefore, many of the requested sections (e.g., sample size for training/test sets, expert qualifications, MRMC studies, standalone algorithm performance) are not applicable or not explicitly detailed in this document, as the regulatory pathway for examination gloves relies on demonstrating equivalence rather than establishing de novo performance characteristics through such studies.
However, I will extract what can be inferred or stated as "not applicable" based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
For examination gloves, the "acceptance criteria" are generally based on recognized standards for physical properties and biocompatibility to ensure they are safe and effective for their intended use and equivalent to existing predicate devices. The document does not explicitly list a table of acceptance criteria or performance metrics specific to the Nitrilon™ Correct-Touch® gloves. Instead, the FDA's clearance implies that the device meets the general controls and equivalence requirements.
Therefore, for this document, a direct table of acceptance criteria and reported performance cannot be generated. The "performance" being assessed here is predominantly the device's substantial equivalence to a predicate device in terms of materials, intended use, and manufacturing processes, rather than a quantifiable performance metric like sensitivity or specificity.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a "test set" in the context of evaluating an AI algorithm's performance. The review is for a physical medical device (gloves) and relies on substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of AI algorithm evaluation is irrelevant here. The FDA's review involves regulatory experts, but they are assessing compliance and equivalence, not establishing a "ground truth" for a dataset.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of AI algorithm evaluation described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document pertains to examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
Not applicable. "Ground truth" is a concept for evaluating algorithms. For medical gloves, the "truth" is established by adherence to recognized standards for materials, manufacturing, and performance (e.g., tensile strength, barrier integrity, biocompatibility), which are demonstrated through testing that is not detailed in this FDA clearance letter.
8. The Sample Size for the Training Set
Not applicable. This document is not about an AI algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned in this document.
Summary based on the provided document:
The provided FDA 510(k) clearance letter for Nitrilon™ Correct-Touch® Powdered Nitrile Examination Gloves is for a physical medical device, not an AI algorithm. The regulatory pathway for such devices focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than on proving performance through studies typically associated with AI or novel diagnostic/therapeutic devices (e.g., clinical trials, AI performance metrics, expert adjudication). Therefore, most of the requested information regarding acceptance criteria, study design parameters (sample sizes, experts, ground truth, MRMC studies, standalone performance) is not available or applicable in this specific regulatory document. The FDA's letter confirms that the device meets the general controls provisions of the Federal Food, Drug, and Cosmetic Act and is substantially equivalent to a predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
Biopro (M) Sdn. Bhd. ·C/O Mr. Mike Kyle President CT International 4349 Santa Fe Road San Luis Obispo, California 93401
Re : K981304
Nitrilon™ Correct-Touch® Powdered Nitrile Trade Name: Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 10, 1998 April 10, 1998 Received:
Dear Mr. Kyle:
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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Kyle
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as The FDA described in your 510 (k) premarket notification. 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the 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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3.0 Indications for Use Statement:
8805 544 5796 ;
Indications For Use:
| Applicant: | CT International |
|---|---|
| 510(k) Number (if known): | K981304 |
| Device Name: | NITRILON CORRECT-TOUCH POWDERED NITRILE Examination Glove |
A medical giove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
CT INTERNAL DUSAL AND CONSULT CONTRACT CONTRACT
154 83 27 4 11 8
(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)
06/05/98
10:35
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Over-The-Counter Use X
escription Use
er 21 CFR 801.109) -
(Optional Format 1-2-96)
Qùin S. Lin
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 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.