(59 days)
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Not Found
No
The device description and intended use clearly define a physical examination glove, with no mention of software, data processing, or AI/ML terms.
No
The device, a Nitrile Powder-free Examination Glove, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
The provided text describes a glove used for preventing contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove made of synthetic materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a glove worn on the hand or finger(s) to prevent contamination between patient and examiner. This is a physical barrier function.
- IVD Definition: In vitro diagnostics (IVDs) 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 provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose related to analyzing substances outside the body.
Therefore, the Nitrile Powder-free Examination Glove, as described, falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Nitrile Powder-free Examination Gloves
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
Hand or finger(s)
Indicated Patient Age Range
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Intended User / Care Setting
Examiner (medical purposes)
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three bars across its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Motex Healthcare Company Limited C/O Mr. Tzu-Wei Li Center for Measurement Standards of Industrial Bldg. 16, 321 Kuang Fu Road, Section 2 Hsinchu, TAIWAN 30042, R.O.C
NOV 2 9 2001
Re: K013261
Trade/Device Name: Motex Nitrile Examination Gloves Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: November 7, 2001 Received: November 20, 2001
Dear Mr. Li:
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.
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
1
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the ret or any 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 (QS) 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 and additionally 21 CFR Part 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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
Applicant: 510(k) Number : __ (New Applicant) ___________________________________________________________________________________________________________________________________________ Device Name: Nitrile Powder-Free Examination Gloves
Indication For Use :
Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) 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)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
×
(Optional Format 1-2-96)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 6 ? O(k) Number .