(64 days)
Not Found
Not Found
No
The 510(k) summary describes a standard surgical glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML devices.
No
The device, a surgical glove, is intended to provide a barrier against contaminants and is not designed to treat or diagnose a medical condition.
No
Explanation: The device is a surgical glove intended as a barrier, not for diagnosing medical conditions.
No
The device is a physical glove made of synthetic rubber, 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 provide a barrier against potentially infectious materials and other contaminants for operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a disposable glove made of synthetic rubber. This description aligns with a physical barrier device, not a diagnostic instrument or reagent.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a medical device, but it falls under the category of a barrier device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber intended to be worn by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.
Product codes (comma separated list FDA assigned to the subject device)
KGO
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
666 21 2 1 2 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8
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 : K991949 Laglove™ Brand Nitrile Surgical Glove-Trade Name: Sterile (Powdered) Requlatory Class: I KGO Product Code: 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, 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 Regulations, Title 21, Parts 800 to 895. ਬੈ 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 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 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 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 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.fdd.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
| Date | 08-18-99 |
|---|---|
| Time | 15:32 |
| Company | BRIGHTWAY HOLDING SDN BHD |
UN 12:54 FAX 301 480 3002
2-2. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
: …
Fax : 6038367455
FDA /QDE/DDIGD
Jan 17 '93 Q6:45
Page 1
of I
..
| g | 403 |
|---|---|
| --- | ----- |
| 510(k) Number (if known): | K 991949 |
|---|---|
| Device Name: | Nitrile Surgical Gloves - Sterile (Powdered) |
| Indications For Use: | |
| LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber intended to be worn by operating room personnel to provide a barrier against potentially infectious materials and other contaminants. | |
| G.Baskaran | |
| Managing Director. | |
| 10th August 99. |
(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 | K991949 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use X
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | ---------------------------------------------------------------------------------------------------- |
|---|
| 10-99 | 08:24 | RECEIVED FROM: 6038367455 | P.03 |
|---|---|---|---|
| ------- | ------- | --------------------------- | ------ |