(20 days)
Not Found
Not Found
No
The summary describes standard examination gloves and contains no mention of AI or ML technology.
No
The device, "patient examination gloves," is intended to prevent contamination, not to treat a disease or condition.
No
This device is described as an examination glove intended for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical medical device (gloves) and does not involve any software component.
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 gloves are for preventing contamination between healthcare personnel and the patient by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of the gloves (material, color, powder-free, protein content). This aligns with a physical barrier device, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Any components typically associated with IVD tests (reagents, calibrators, controls, instruments for analysis).
Therefore, the device described is a medical device used for personal protection and infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Product codes
LYY
Device Description
Green Chlorinated Powder Free Latex Examination Gloves With Protein Content Labeling Claim of 50 micrograms or less.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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
Not Found
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 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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Ms. Nurul Aisyah Kong Quality Assurance Manager Hartalega Sdn. Bhd. 9, Jalan Kuang Bulan Taman Kepong Industrial Estate 52100 Kuala Lumpur, Malaysia
Re : K993725 Green Chlorinated Powder Free Latex Trade Name: Examination Gloves (With Protein Labeling Claim) Requlatory Class: I Product Code: LYY Dated: October 29, 1999 November 3, 1999 Received:
Dear Ms. Kong:
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 Regulations, Title 21, Parts 800 to 895. ਰ 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Kong
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 requlation (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 compriated as (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,
U.J. Qulatrust
Timothy R. Ulatowski
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
INDICATIONS FOR USE
HARTALEGA SDN. BHD. Applicant :
510(k) Number (if known) :
Device Name : Green Chlorinated Powder Free Latex Examination Gloves With Protein Content Labeling Claim of 50 micrograms or less.
Indications For Use :
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use | |
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(Per 21 CFR 801.109) |
OR
Over-The-Counter Use | |
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(Optional Format 1-2-96) |
(Division Sign-Off) | |
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Division of Dental, Infection Control, and General Hospital Devices | |
510(k) Number | K993725 |