(64 days)
Not Found
Not Found
No
The document describes a surgical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device description and intended use clearly state that the product is a surgical glove, which is a barrier device for contamination prevention, not a therapeutic intervention.
No
Explanation: The device is described as a disposable glove intended to prevent contamination during surgical procedures, not to diagnose a condition.
No
The device description clearly states it is a "disposable glove made of synthetic rubber," which is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating personnel during surgical procedures to prevent contamination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a disposable glove made of synthetic rubber. This is a medical device used for protection, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worn by operating personnel to protect a surgical patient and personnel from transfer of materials and other contaminants.
Product codes
KGO
Device Description
Not Found
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 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
§ 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 Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of three stylized human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1:2 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
Re : K991950 Laglove™ Brand Nitrile Surgical Glove-Trade Name: Sterile (Powder-Free) Regulatory Class: I Product Code: KGO Dated: May 28, 1999 Received: June 9, 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 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 regulations 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) 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 obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Baskaran
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 asbellence for portantial 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) 638-204% or (301) 443-6597 or at its internet address "http://www.fda/.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
BRIGHTWAY HOLDING SDN BHD 15:32 08-10-99 Fax : 6038367455 un 12:04 FAX 201 480 300 FDA/QDE/DDIGD ID=603+3414800
Jan 17 '93 06:45
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P .
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510(k) Number (if known): K 991950
Dovice Namo: Nitrite Surgical
Indications For Use:
LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a LAGLOVE'''' Brand Nittle Surgical Gloves intended to be worn by operating disposable glove made of synthelic rubber intendou'ts be works your learly and interials and other contaminants.
G.Baskaran
Managing Director. 10th August 99.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NE
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| (Division Sign-Off) | ||||
| Division of Dental, Infection Control, | ||||
| and General Hospital Devices | ||||
| 510(k) Number | 991950 |
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X
(Optional Format 1-2-96)
18-99 08:24 RECEIVED FROM: 6038367455 P.03
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