(65 days)
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Not Found
No
The document describes a standard medical glove and contains no mention of AI, ML, or related concepts.
No
The device is described as a "powder-free patient examination glove" intended to "provide a barrier against potentially infectious materials and other contaminants." This function is protective, not therapeutic.
No
Explanation: The device is described as a glove intended to provide a barrier against infectious materials, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical product (gloves) and there is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free patient examination glove" intended to be worn on the hand or finger(s) as a barrier against infectious materials and contaminants. This is a physical barrier device used for protection during medical procedures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform any such testing.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infections materials and other contaminants.
Product codes
LYY
Device Description
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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 or finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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 logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top and left side of the circle.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Ms. Yim Hoon Pung General Manager KL Kepong Rubber Products Sdn Bhd. Ladang Pinji, Bahagian Sengat, 31300 Kampung Kepayang, Ipoh, Perak Darul Ridzuan, MALAYSIA
Re: K023866
Trade/Device Name: Powder Free Polymer Coated (Acrylic Based) Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 19, 2002 Received: November 20, 2002
Dear Mr. Pung:
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 your 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.
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Page 2 - Mr. Pung
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), 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) you may obtain. 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,
Susa Russo
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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3.0 INDICATIONS FOR USE STATEMENT :
APPLICANT : KL KEPONG RUBBER PRODUCTS SDN. BHD.
| 510(K) | KO23866 |
|---|---|
| -------- | --------- |
DEVICE NAME POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES
N FOR USE INDICATION FOR USE .
A powder-free patient examination glove is a disposable device
made of natural rubber latex or synthetic material that may bear a
trace amount of glove powder and is intended to be worn on the
hand or finger(s) for medical purposes to provide a barrier against
potentially infections materials and other contaminants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clain Schim
Gener
510(k) Number: K023866