(59 days)
Not Found
Not Found
No
The device is a disposable medical glove, and the summary contains no mention of AI, ML, or any related technologies.
No.
The glove is described as an examination glove to prevent contamination, not to treat a medical condition or disease.
No
Explanation: The device is a glove for preventing contamination between patient and examiner, not for diagnosing a medical condition.
No
The device description clearly states it is a physical glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description: The description clearly states this is a "Latex Examination Glove" worn on the examiner's hand.
- Intended Use: The intended use is to "prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a specimen.
The information provided describes a medical device used for personal protection and infection control, which 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
Polymer Coat, Powder Free, Latex Examination Gloves
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
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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): 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.
Not Found
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.
Not Found
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 shows the logo for the U.S. Department of Health and 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 that resembles a stylized caduceus or a representation of the human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1999
Mr. Foo Khon Pu Managing Director Smart Glove Corporation Sdn. Bhd. Lot 6487, Batu 5% Sementa, Jalan Kapar 42100 Klang Selangor Darul Ehsan MALAYSIA
Re : K991624 Polymer Coat, Powder Free, Latex Examination Trade Name: Gloves Requlatory Class: I Product Code: LYY May 8, 1999 Dated: Received: May 11, 1999
Dear Mr. Foo Khon Pu:
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 Requlations, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Foo Khon Pu
this response to your premarket notification Please note: Please noce: this rebported on pobligation you might have under submission accommon and of for devices under the Sections 331 through 318 chool provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as This lecter will and (k) premarket notification. The FDA described in your 510 m, promatence of your device to a legally Finding of substancial equirality in a classification for your marketed predicate device robals, as a proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulacion (21 crit rares), please contact the Office of Villo draghosere actross, , p. Additionally, for questions on Compilance at (301) 337 issues of your device, please contact che Dromocion and advorozed (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference bo the regulacion cherosou, 21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsibilitiis and Manufacturers Assistance obtained from the Brvibron or 6301) or (301) 443-6597 or at at its coll free namber (o://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 Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the words "SMART GLOVE CORPORATION SDN. BHD." in bold, black letters. The words are arranged in three lines, with "SMART GLOVE" on the first line, "CORPORATION SDN." on the second line, and "BHD." on the third line. The text appears to be a company name or logo.
Company No. 403570 - D
Page 3 of 50
3.0 Indication for Use Statement.
INDICATION FOR USE
SMART GLOVE CORPORATION SDN BHD. Applicant :
510(k) Number K99 | 624
Polymer Coat, Powder Free, Latex Examination Gloves Device Name:
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)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter (Optional Format 1-2-96)
Clim S. Lin
(Division Sign-Off Division of Dental. Inf and General Hospit 510(k) Number