(28 days)
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Not Found
No
The device description is for a standard medical examination glove and there are no mentions of AI, ML, or related concepts.
No
The device is a glove intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic action.
No
Explanation: The device is described as a "patient examination glove" used to prevent contamination, which is a barrier device for protection, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (latex examination 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 clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used for infection control during patient examination.
- Device Description: The description details the material and features of a glove.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the body, not as a physical barrier during examination.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
POWDER FREE ( SILICON COATED ) LATEX EXAMINATION GLOVES. WITH PROTEIN LABELING CLAIM (50 micrognam or less
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
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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)
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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.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Mr. P. Sundaram General Manager (Marketing) Pan-Century Rubber Products Sdn. Bhd. Lot No. 230, Jalan Timah 2 Pasir Gudang Industrial Estate 81700 Pasir Gudang Johor, MALAYSIA
Re : K993287 Trade Name: Powder Free (Silicon Coated) Latex Examination Gloves with Protein Labelling Claim, 50 Micrograms or Less Regulatory Class: I Product Code: LYY September 28, 1999 Dated: Received: October 1, 1999
Dear Mr. Sundaram:
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
1
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 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) 594-4692. 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 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 Radioloqical Health
Enclosure
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Image /page/2/Picture/2 description: The image shows a logo for a quality system. The logo consists of a black diamond shape with the words "QUALITY SYSTEM" written in white inside a white oval shape at the top. Below the diamond, the text "SIRIM QUALITY SYSTEM MS ISO 9002 REGISTRATION NO 0400" is printed in black.
CENTURY RUBBER PRODUCTS SDN. BHD.
or No. 230, Jalan Timah 2, Pasir Gudang Industrial Estate, 81700 Pasir Gudang, Johor, Malaysia. Tel: +60-7-251 8551 / 251 0115 / 251 6537 Fax : +60-7-251 3481
Image /page/2/Picture/5 description: The image shows a black and white logo. The logo appears to contain the letters 'PC' in a stylized font. The letters are partially obscured by a circular shape that surrounds them. The top of the logo features two bulbous shapes connected by thin lines, resembling a stylized representation of a chemical flask or a similar scientific apparatus.
ANNEXURE 'A'
OCTOBER 20, 1999
GLOVE REVIEW SUMMARY K 993287
POWDER FREE ( SILICON COATED ) LATEX EXAMINATION GLOVES. WITH PROTEIN LABELING CLAIM (50 micrognam or less
INDICATION FOR USE STATEMENT
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Olin S. lin
(Paurinn Sign-Off) Control of Dental, Infection Control a General Hospital De 5 i O(k) Number _