(44 days)
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No
The summary describes a standard medical examination glove and contains no mention of AI, ML, or any related technologies or performance metrics typically associated with AI/ML devices.
No
The device is described as an examination glove intended to prevent contamination, not to treat or cure a medical condition.
No
Explanation: The device, Powder Free Latex Examination Gloves, is intended to prevent contamination between patient and examiner. It does not gather information for the purpose of identifying a disease or condition.
No
The device is a physical glove, not software. The description clearly states it is a "Powder Free Latex Examination Glove".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be worn on the examiner's hand to prevent contamination. It does not involve testing or analyzing any biological samples.
- The description focuses on a physical barrier. The device description details the material (latex), powder status, and protein labeling claim, all of which relate to the physical properties of the glove as a barrier.
- There is no mention of any diagnostic purpose. The intended use clearly states its purpose is to prevent contamination, not to diagnose, monitor, or treat any condition based on analysis of biological samples.
This device is a medical device, specifically a medical glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Powder Free Latex Examination Gloves, with protein labeling claim (50 micrograms 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
hand
Indicated Patient Age Range
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Intended User / Care Setting
examiner
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1099
Mr. Kenny H. N. Liew Executive Director FLEXITECH SDN. SDN.BHD. Lot 5071, Batu 5 1/2 Jalan Meru, 41050 Klang, Selangor Darul Ehsan, MALAYSIA
Re : K990501 Powder-Free Natural, Blue, and Green Latex Trade Name: Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: Product Code: LYY Dated: February 12, 1999 February 17, 1999 Received:
Dear Mr. Kenny H. N. Liew
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 The general controls provisions of the Act 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 (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. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Kenny H. N. Liew
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,
Patutue Ciceraitzffer
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "FLEXI" in bold, uppercase letters. Below the word is a rectangle that is partially filled in with black. The left portion of the rectangle is white, creating a square shape within the rectangle. The overall design is simple and graphic.
FLEXITECH SDN. BHD.
Company No: 165532 - M Lot 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: 03-6372878-Fax: 03-6379878 NEW TEL: 603 3920188 FAX : 603 3920228
3.0 Indications for Use Statement.
Page 3 of 103
INDICATIONS FOR USE
| Applicant : | FLEXITECH SDN BHD |
|---|---|
| 510(k) Number | K990501 |
| Device Name: | Powder Free Latex Examination Gloves, with protein labeling claim (50 micrograms or less) |
| Indication For Use : |
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office Of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
scription Use Jr 21 CFR 801.109
Over-The-Counter : OR (Optional Format 1-2-96)