(44 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard surgical glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as a surgical glove intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a physical product (surgical gloves) and does not involve any software components.
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 "intended to be worn by operating room personnel to protect a surgical wound from contamination." This describes a physical barrier function for protection during surgery.
- Device Description: The description focuses on the material (Natural Rubber), sterility, and protein content, all relevant to a surgical glove's function as a barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
Therefore, the LAGLOVE™ Brand Latex Surgical Gloves are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water Extractable protein per gram.
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
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
Not Found
Key Metrics
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 is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a wavy line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. G. Baskaran Managing Director LAGLOVE (M) SDN. BHD. Lot 478, Jalan Simpang Balak Off Batu 13, Jalan Cheras 43000 Kajang, Selangor Darul Ehsan MALAYSIA
K992018 Re:
LAGLOVE™ Powdered Latex Surgical Gloves Trade Name: With Protein Content Labeling Claim (150 Micrograms Or Less) I Requlatory Class: Product Code: KGO Dated: June 11, 1999 Received: June 16, 1999
Dear Mr. Baskaran:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marker 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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੇ 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.
1
Page 2 - Mr. Baskaran
In addition, FDA may publish further announcements concerning your device in the Federal Register.
this response to your premarket notification Please note: 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 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,
Timothy W. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K992018
Indications for use 3.0
| Applicant | : LAGLOVE (M) SDN. BHD. |
|---|---|
| 510(k) number | : |
| Device name | : LAGLOVE™ Brand Latex Surgical |
| Gloves - Sterile (Powdered) | |
| Containing 150 µgm or less of water | |
| Extractable protein per gram. |
Indications for use:
LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Claus S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospi 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use$\times$
(Optional Format 1-2-96)
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