(36 days)
Not Found
Not Found
No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, or related technologies.
No.
The device is described as an examination glove intended to prevent contamination, which is a barrier protection and not a therapeutic function.
No
Explanation: The device is described as a glove intended to prevent contamination, which is a protective barrier function, not a diagnostic one. It does not perform any tests or analyses to identify diseases or conditions.
No
The device is described as a physical glove, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a glove worn on the examiner's hand to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is for a physical glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition or disease.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
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 Glove, Polymer Coated Powder Free, Blue
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 - 2000
Mr. Y. F. Hew Factory Manager Flexitech Sdn. Bhd. Lot 5071, Batu 5 ½ Jalan Meru 41050 Klang Selangor, Malaysia
Re : K994416 Trade Name: Nitrile Examination Glove, Polymer Coated Powder Free, Blue Regulatory Class: I Product Code: LZA Dated: December 20, 1999 Received: December 23, 1999
Dear Mr. Hew:
This letter corrects our substantially equivalent letter of February 3, 2000, regarding the Device Name and Product Code.
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 Regulations, Title 21, Parts 800 to 895. A 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Hew
the Act for devices under the Electronic Product Radiations the Act for devices under the 22000 millions or regulations.
This letter will allow you to begin marketing your device as first recei will arem for market notification. The FDA described in your sisting providence of your device to a legally marketed predicate device results in a classification for your marketed predicate device rebares in to proceed to the market.
If you desire specific advice for your device on our labeling II you desire Specific advice acciditionally 809.10 for in regulacion (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compliance at (301) of ising of your device, please contact the Dromocion and advertibility or Jose-4639. Also, please note the Orice Or Compiland, "Misbranding by reference to ene regulation scation" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obcained from the bivibion or (800) 638-2041 or (301) 443-6597 or at at Its coll-free namber (0:0)/www.fda,gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A 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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Image /page/2/Picture/0 description: The image shows a logo with the word "FLEXI" in bold, block letters at the top. Below the word, there is a rectangular shape that is divided into two parts. The left part of the rectangle is white, while the right part is black. The logo has a simple and modern design.
LEXITECH SDN. BH
Vo: 165532 - 1
x 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: 603-3920188 Fax: 603-3920228
Page 3
ﺗﻬ
Indications for Use Statement. 3.0
INDICATIONS FOR USE
FLEXITECH SDN BHD Applicant :
K9944-16 510(k) Number
Device Name: Polymer Coated Powder Free Nitrile Examination Gloves, BLUE
Indication 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 PAGE IF NEEDED Concurrence of CDRH, Office Of Device Evaluation (ODE)
Qlin S. Lin
Mivision Sign-Off) Division of Dental, Infection Control, And Ceneral Hospital De 1991. Number -
cription Use Per 21 CFR 801.109 OR Over-The-Counter : (Optional Format 1-2-96)