(32 days)
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Not Found
No
The summary describes a standard medical glove and contains no mention of AI, ML, or related technologies.
No
A therapeutic device is used to treat or cure a disease or condition. This device, a medical glove, is for contamination prevention and does not treat or cure any condition.
No
Explanation: The device is a medical glove, designed to prevent contamination between healthcare personnel and patients. Its function is to provide a physical barrier, not to diagnose any medical condition or disease.
No
The device description clearly states it is "NITRILE LATEX EXAMINATION GLOVES, POWDERFREE," which are physical hardware devices. There is no mention of software as the primary component or function.
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 test performed on samples taken from the body.
- Device Description: The device is a glove, which is a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
"A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient."
Product codes
LZA
Device Description
Nitrile Examination Gloves Powderfree
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
Indicated Patient Age Range
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Intended User / Care Setting
health care 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.
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Mr. Rajeev Kumar Sood President & CEO Innovative Gloves Company, Ltd. 11, Chotevittayakul 3 Road Khohong, Hatyai Songkhla 90110 Thailand
Re : K993325 Trade Name: Nitrile Examination Gloves Powderfree Regulatory Class: I Product Code: LZA Dated: September 29, 1999 Received: October 4, 1999
Dear Mr. Sood:
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
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Page 2 - Mr. Sood
obligation you might have under sections 531 through 542 of obligation you may 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 markets production of mits 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 requlation 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
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/4 description: The image shows a stylized letter 'G' in black. A small hand icon is positioned above the letter, slightly to the left. The letter 'G' has a horizontal line cutting through its center, creating a gap in the shape.
บริษัท อินโนเวทีฟ โกรฟส์ จำกัด INNOVATIVE GLOVES Co., Ltd.
11, CHOTEVITTAYAKUL 3 ROAD, KHOHONG, HATYAI SONGKHI A 90110 TEL. (074) 428408 FAX : (074) 428409 MOBILE : 66-1-897982 I
Subject: K993325 Amendment Number : 1
Page 1 of 1
INDICATIONS FOR USE
Applicant's Name: INNOVATIVE GLOVES CO: LTD
510 (k) Number (if known): K993325
Davice Name: NITRILE LATEX EXAMINATION GLOVES, POWDERFREE
INDICATIONS FOR USE:
"A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109) ાર
Over-The -Counter-Use (Optional Format 1-2-98)
Ajer her dnd.
In Clin SPB (Division Sign-Off) Consion of Dental, Infection Control, · General Hospital "!!! › Number _