(376 days)
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No
The device is a glove and the summary does not mention any AI/ML related terms or functionalities.
No
The device, Powder-Free Nitrile Exam Glove, is described as preventing contamination between patient and examiner and is worn on the examiner's hand. It does not treat, diagnose, cure, or mitigate a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is a glove for preventing contamination, not for diagnosing conditions.
No
The device described is a physical glove, not software. The description clearly states it is a "Powder-Free Nitrile Exam Glove" worn on the hand.
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 "general purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for personal protection and hygiene, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description is for "Powder-Free Nitrile Exam Gloves," which are physical barriers.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVDs are devices used to perform tests on specimens (like blood, urine, tissue) to get information about a person's health. This glove does not perform any such test.
N/A
Intended Use / Indications for Use
Powder-Free Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is a general 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
Powder-Free Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
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 (general 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): 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.
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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 features a stylized depiction of a human figure with three flowing lines representing the body, head, and arms. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 3 2000
Mr. Belle Chou General Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
K991422 Re : Powder-Free Nitrile Examination Glove Trade Name: (Tested for Use with Chemotherapy Drugs) Regulatory Class: I Product Code: LZA March 8, 2000 Dated: March 9, 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, 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 Requlations, Title 21, Parts 800 to 895. ਸੋ 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 requlation may result in requlatory 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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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 qeneral 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
Timõ thy A. Ulatows Diredtor 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" made up of two curved black shapes, one above the other. Below the symbol, the text "SHEN WEI INC." is arranged in three lines, with each word stacked vertically. The text is in a simple, sans-serif font and is also black.
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Device Name: Powder-Free Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
Indication For Use:
Powder-Free Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is a r owdern Tec Nialle Exam Glove (Tocal 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)
SBarrd by Can
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K 991432
Prescription Use Per 21CFR 801.109 OR
Over-The Counter
(Optional Format 1-2-96)