(53 days)
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Not Found
No
The summary describes a standard medical examination glove with no mention of AI or ML capabilities.
No.
The device, a nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.
No
Explanation: The device is described as a glove intended to prevent contamination, which is a barrier function, not a diagnostic one. It does not analyze or interpret data to identify a medical condition.
No
The device description clearly states it is a "Nitrile Examination Glove," which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Description and Intended Use: The provided information clearly states that this device is a disposable glove intended to be worn on the examiner's hand to prevent contamination. It is a physical barrier, not a test performed on a biological sample.
The device described is a medical device, specifically a Class I or Class II medical glove, but it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Product codes
LZA
Device Description
Nitrile Examination Gloves, Powder Free, Blue Glove
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Examiner's hand
Indicated Patient Age Range
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Intended User / Care Setting
Examiner
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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: K023978
Trade/Device Name: Nitrile Examination Gloves, Powder Free, Blue Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA 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 (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 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 Suarez
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: NITRILE EXAMINATION GLOVES, POWDER FREE,
Indications For Use: THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE 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 PAG NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__ OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off) (Optional Format
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K023928