(68 days)
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Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device, "Powdered Green Latex Examination Gloves," is intended for protection and contamination prevention, not for treating or diagnosing a medical condition.
No
The device is described as "Powdered Green Latex Examination Gloves" worn for protection and to prevent contamination. There is no information suggesting it is used for diagnosis, disease detection, or monitoring.
No
The device description clearly states it is a "Powdered Green Latex Examination Glove," which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is a glove. Its purpose is to provide a physical barrier for protection during medical procedures. It does not analyze any biological samples.
The intended use clearly states it's for "worn on the hands... to give an additional protection... to prevent contamination". This is a protective barrier device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.
Product codes
LYY
Device Description
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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
hands, arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care and similar personnel
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)
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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
Mr. T.S. Puon Factory Manager Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6 Off Jalan Meru, 41050 Klang Selanqor D.E., Malaysia
K993452 Re: Green Powdered Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: October 11, 1999 Received: October 13, 1999
Dear Mr. Puon:
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 reqistration, 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 Requlations, Title 21, Parts 800 to 895. ಗ 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 Druq 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 not affect any
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Page 2 - Mr. Puon
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 findinq 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,
Susan Runoco
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
3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The iformation, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
| Applicant: | TOP GLOVE SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K993452 * |
| Device Name: | Powdered Green Latex Examination Glove |
| Indications For Use: |
Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Jamy Surnor for Chris Lin RD
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use .er 21 CPR 801.109
OR
Over-The-Counter
- For a new submission, do NOT fill in the 510(k) number blank.
(Optional Format 1-2-96)