(158 days)
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Not Found
No
The device description is for examination gloves, which are passive barriers and do not incorporate AI or ML technology. The summary contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device, a patient examination glove, is intended as a barrier against infectious material, not to treat or cure a disease or condition.
No
Explanation: The device is described as an examination glove intended to provide a barrier against infectious material, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (gloves made of latex or synthetic material) and not software.
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 GLOVES" intended to be worn on the hand or finger(s) for medical purposes to provide a barrier. This describes a physical barrier device used for protection, not a device used to examine specimens taken from the human body.
- Device Description: The description reinforces the intended use, describing the material and purpose as a barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are designed to perform tests in vitro (outside the body).
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL 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
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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): 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
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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
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 is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2003
Mr. Upul Gunasinghe Quality Assurance Manager Lalan Glove (PVT) Limited Block B. Bepz Biyagama, Sri Lanka T.P. 009414-65802
Re: K031386
Trade/Device Name: Glove Powder Free Patient Examination, Latex Regulation Number: 880:6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 16, 2003 Received: August 25, 2003
Dear Mr. Gunasinghe:
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. Gunasinghe
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. 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 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,
Susan Kuonen
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Sample Format
INDICATIONS FOR USE
: LALAN GLOVES (PVT) LTD. Applicant's Name
510(k) Number (if known)* : K031386
: GLOVE, POWDER FREE, PATIENT EXAMINATION, LATEX Device Name
Indications For Use :
A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.
Qhin S. Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev
510(k) Number: K031386