(29 days)
Not Found
Not Found
No
The 510(k) summary describes a standard surgical glove and contains no mention of AI or ML technology.
No.
A surgical glove is a barrier device for protection, not a device used to treat or alleviate a disease or condition.
No
Explanation: The device, a surgical glove, is intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a physical surgical glove made of natural rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Surgical Glove Function: The intended use of the surgical glove is to create a physical barrier between the operating room personnel and the patient's surgical wound. It's a protective device used during a medical procedure, not a test performed on a sample.
The provided information clearly describes a physical barrier device used in a surgical setting, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a gurgical wound from contamination between the patient and the surgeon.
Product codes
KGO
Device Description
LATEX SURGICAL GLOVE, POWDERED AND STERILE
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel / Per the Indications for Use, "operating room personnel" and "surgical wound" imply a surgical setting.
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Wee-Chai Lim Manaqing Director TG MEDICAL SDN. BHD. Lot 5091, Jalan Teratai, 5 ° Mile Off Jalan Meru 41050 Klang, Selangor Darul Ehsan MALAYSIA
Re : K992219 Powdered Latex Sterile Surgical Gloves Trade Name: Regulatory Class: I Product Code: KGO Dated: June 28, 1999 Received: July 1, 1999
Dear Mr. Wee-Chai Lim:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Reqister.
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Page 2 - Mr. Wee-Chai Lim
Please note: this response to your premarket notification submission does 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 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 requlation 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,
Timothy A. Ulatowski
Timberhy A. Ulatow 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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
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INDICATIONS FOR USE
| Applicant: | TG MEDICAL SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K.992219 * |
| Device Name: | LATEX SURGICAL GLOVE, POWDERED AND STERILE |
| Indications For Use: |
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a gurgical wound from contamination between the patient and the surgeon.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K992219 |
OR
| Prescription Use Per 21 CFR 801.109 | |
|---|---|
| Over-The-Counter | X |
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- For a new submission, do NOT fill in the 510(k) number blank.