(84 days)
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No
The 510(k) summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device, a Powder-Free Nitrile Exam Glove with Aloe Vera, is intended to prevent contamination between patient and examiner. It does not provide any therapeutic benefit or treatment.
No
Explanation: The device, Powder-Free Nitrile Exam Glove with Aloe Vera, is intended to prevent contamination between patient and examiner and is not described as diagnosing any condition.
No
The device is a physical glove, not software. The description clearly states it is a "Powder-Free Nitrile Exam Glove".
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 "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description is for a glove, which is a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro for diagnostic purposes.
Therefore, this device falls under the category of a medical device, but specifically a barrier device for examination, not an IVD.
N/A
Intended Use / Indications for Use
Powder-Free Nitrile Exam Glove with Aloe Vera is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Product codes
LZA
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
Examiner (medical purpose)
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)
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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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three abstract human profiles facing right, with flowing lines beneath them, suggesting movement or energy. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Mr. Belle L. Chou General Manager Shen Wei, Incorporated 2845 Whipple Road Union City, CA 94587
Re : K993876 Powder-Free Nitrile Examination Gloves with Trade Name: Aloe Vera, Green Color Regulatory Class: I Product Code: LZA Dated: January 17, 2000 January 18, 2000 Received:
Dear Mr. Chou:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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
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Page 2 - Mr. Chou
obligation you might have under sections 531 through 542 of 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 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 requlation (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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Image /page/2/Picture/0 description: The image shows a logo for Shen Wei Inc. The logo consists of a stylized letter "S" above the company name. The letter "S" is made up of two curved shapes, one on top of the other. The company name is written in a simple, sans-serif font.
Attachment Two
INDICATION FOR USE
Applicant: Shen Wei (USA) Inc.
Device Name: Powder-Free Nitrile Exam Gloves with Aloe Vera, GREEN
Indication For Use:
Powder-Free Nitrile Exam Glove with Aloe Vera is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| Per 21CFR 801.109 |
OR
Over-The-Counter
(Optional Format 1-2-96)
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Chun S. Lin
(Division Sign-Off) Division of Dental, Infection Cor and General Hospita 510(k) Number