(42 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device, a patient examination glove, is intended to prevent contamination but does not provide any therapeutic benefit to the patient.
No
Explanation: The "Intended Use / Indications for Use" states that the device is a "Patient Examination Glove" worn on the hand or finger "to prevent contamination between patient and examiner." This describes a barrier device, not one used for diagnosis.
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 devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Intended Use: The intended use of the Patient Examination Glove is to prevent contamination between the patient and the examiner by being worn on the hand. It does not involve testing specimens from the body.
- Device Description: The description confirms it's a glove for examination, not a diagnostic test.
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples
- Providing diagnostic information
- Using reagents or assays
Therefore, based on the provided information, the Patient Examination Glove is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purpose
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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 Department of Health & Human Services - USA. 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 image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lim Lee Aik Manaqing Director SRI Johani Sdn. Bhd. Lot PT 7178, Balakong N/V, 43300 Seri Kembangan Selangor Darul Malaysia
DEC 18 1997
K974184 Re: Safety Powderfree Blue Latex Examination Trade Name: Gloves (Polymer Coated) Regulatory Class: I Product Code: LYY October 17, 1997 Dated: Received: November 6, 1997
Dear Mr. Lee Aik:
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 aqainst 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) 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. Please note: this response to your premarket notification submission does
1
Paqe 2 - Mr. Lee Aik
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 requlations.
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) 594-4618. 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" (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.qov/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
2
Attachment 8
ID=603 9611213
510(k) number (if known): K974184
Safety Powderfree Blue Latex Examination Gloves Device Name: Polymer Coated )
Indications For Use:
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or contamination finger prevent between to patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oisin E. Lira
(Division Sign Off)
of Dental. Infe
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
iOptional Pornat 1-2-96)