(20 days)
Not Found
Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device description clearly states it is for preventing contamination, not for treating any specific condition or disease.
No
The device is described as examination gloves used to prevent contamination, not for diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states the device is a "patient examination glove" worn on the hand to prevent contamination. This is a barrier device used externally, not for analyzing specimens from the body.
The information provided aligns with a Class I or Class II medical device, but not an IVD.
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
Blue 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 an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Ms. Nurul Aisyah Kong Ouality Assurance Manager Hartalega Sdn. Bhd. 9, Jalan Kuang Bulan Taman Kepong Industrial Estate 52100 Kuala Lumpur, Malaysia
Re : K993722 Blue Chlorinated Powder Free Latex Trade Name: Examination Gloves (With Protein Labeling Claim) Regulatory Class: I Product Code: LYY October 29, 1999 Dated: 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੋ 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 requlation 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 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.ffa.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
2
INDICATIONS FOR USE
HARTALEGA SDN. BHD. Annlicant :
510(k) Number (if known) : 993722
Device Name : Blue 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 | OR Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K993722 |