(30 days)
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No
The 510(k) summary describes a simple disposable glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, disposable gloves, is primarily intended for barrier protection to prevent contamination, not for treating a disease, injury, or medical condition.
No
The device is described as disposable gloves used to prevent contamination, which is a protective function, not a diagnostic one. It does not measure, analyze, or interpret any physiological data to determine a medical condition or disease.
No
The device description clearly states it is a physical product (disposable gloves) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and patients by being worn on the hand. This is a barrier function, not a diagnostic function.
- Device Description: The description is of a physical barrier (gloves).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- No Mention of IVD-Related Terms: The document does not contain any terms typically associated with IVDs, such as "assay," "reagent," "analyzer," "diagnostic test," etc.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Product codes
LYZ
Device Description
Disposable Powder Free Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)
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
Healthcare and similar personnel
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. Gui-Xi Liu General Manger Shijiazhuang Hongray Plastic Products Company, Limited No. 135 Xinhua West Road Shijiazhuang City, Hebei Province China
K992860 Re : Disposable Powder Free Vinyl Synthetic Trade Name: Examination Gloves, White Color (Sensi-Pro) Requlatory Class: I Product Code: LYZ Auqust 8, 1999 Dated: Received: August 25, 1999
Dear Mr. Liu:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ 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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Page 2 - Mr. Liu
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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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SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO
No. 135 Xinhua West Road, Shijiazhuang City, Hebei Province, China Tel: 86-311-3613127 3634449 Fax: 86-311-3634221 Attachment I Email: hongray@public.sj.he.cn
Indication For Use
| Applicant: | Gui-Xi Liu, Shijiazhuang Hongray Plastic Products Co., LTD. |
|---|---|
| ------------ | ------------------------------------------------------------- |
K992860 510K Number(if known):
Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)
Indication For Use:
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Truthfully Yours,
刘贵吉
Gui-Xi Liu General Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE) Over-The-Counter Use __ X Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital J 510(k) Number