(15 days)
Not Found
Not Found
No
The 510(k) summary describes examination gloves and does not mention any AI or ML capabilities.
No.
Explanation: The device is described as an examination glove used to prevent contamination, not to treat or diagnose a medical condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose any condition.
No
The device description clearly states it is a physical product (latex examination gloves) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are worn on the hand of healthcare personnel to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics of the glove (latex, polymer coated, powder free).
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. Examination gloves do not perform this function.
N/A
Intended Use / Indications for Use
Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, WITH PROTEIN LABELING CLAIM (100 mic
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
Not Found
Intended User / Care Setting
healthcare 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.)
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Predicate Device(s)
Not Found
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human figures in profile, arranged in a row.
MAY 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Umair Ahmed Project Manager Industrial Clothings, Limited Prime Polymers Division 481A. Prince Of Wales Avenue Colombo 14, SRI LANKA
Re: K021465
Trade/Device Name: Midas Touch™ Latex Examination Gloves-Polymer Coated, Powder Free with Protein Labeling Claim (100 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 20, 2002 Received: May 7, 2002
Dear Mr. Ahmed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Umair Ahmed
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618_ 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Architect
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Industrial Clothings Limited
(Prime Polymers Division) (11the 1 or enginsion for Latex Examination Glove – Polymer coated, Powder free
3.0 Indications for use
Applicant
KO21465
: Industrial Clothings Ltd. (Prime Polymers Division)
510(k) number Device name
: KOZ-1465
: Midas Touch™ Latex Examination Gloves - Polymer coated, Powder free WITH PROTEIN LABELING CLAIM (100 mic
Indications for use:
Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Clim S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number