(39 days)
Not Found
Not Found
No
The summary describes a standard medical glove with no mention of AI/ML, image processing, or related performance metrics.
No.
The device, a latex examination glove, is intended to prevent contamination between healthcare personnel and patients, which is a barrier function, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device, latex examination gloves, is described as preventing contamination, which is a protective function rather than a diagnostic one. It does not identify or detect diseases or conditions.
No
The device description clearly states it is a physical product (latex examination gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to prevent contamination between healthcare personnel and patients by being worn on the hand. It does not involve the analysis of any biological samples.
- The device description is for latex examination gloves. Gloves are a barrier device, not a diagnostic tool.
- The intended use is for barrier protection. The purpose is to prevent the transfer of contaminants, not to diagnose a condition or provide information about a patient's health status based on a biological sample.
The information provided clearly indicates this is a medical device intended for barrier protection, not for in vitro diagnostic testing.
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
LYY
Device Description
LATEX EXAMINATION GLOVES, PREPOWDERED
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 circular logo for the Department of Health & Human Services - USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, with flowing lines suggesting hair or movement.
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 Khohonq, Hatyai Songkhla 90110 Thailand
Re : K993221 Trade Name: Latex Examination Gloves Prepowdered Requlatory Class: I Product Code: LYY Dated: September 23, 1999 Received: September 27, 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 reqistration, 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 exigation 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 marroos 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 organs on 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,
hy A. Ulatowski Tir Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
400 14 420403
Image /page/2/Picture/4 description: The image shows a stylized letter G in black. The letter is split horizontally into two parts. Above the letter, there is a small graphic of a hand.
:
1
บริษัท ฮินโนเวทีฟ โทรฟฟ์ส์ จำกัด INNOVATIVE GLOVES Co., Ltd.
11, CHOTEVITTAYAKUL 3 ROAD, KHOHONG, HATYAI SONGKHILA 90110 FAX : (074) 428409 TEL. (074) 428408 MOBILE : 66-1-89798 ?1
Subject: 1993221 Amendment Nighber ; 1
Page 1 of 1
INDICATIONS FOR USE
Applicant's Name: INNQVATIVE GLOVES CQ: LTD
510 (k) Number (if known): K993221
Device Name , LATEX EXAMINATION GLOVES, PREPOWDERED
INDICATION FOR USE:
"A Medical glc ve is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient."
| currence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | ----------------------------------------------------- |
| Prescription Use
(Per 21 CFR 80) 109) | OR Over-The-Counter-Use
(Optional Format 1-2-98) |
| ------------------------------------------ | ----------------------------------------------------- |
|---|
| (Division Sign-Off)
Division of Dental, Infection Control,
| and General Hospital Devices | |
|---|---|
| 510(k) Number | K993221 |