(33 days)
Not Found
Not Found
No
The 510(k) summary describes surgical gloves and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
Explanation: The device is described as a surgical glove intended to protect a surgical wound from contamination, which is a barrier function, not a therapeutic action.
No
The device, BRIGHTWAY™ Brand Nitrile Surgical Gloves, is described as a disposable glove worn to protect surgical wounds from contamination, not to diagnose a condition.
No
The device description clearly states it is a "Nitrile Surgical Glove," 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 a user to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "Nitrile Surgical Gloves - Sterile (Powdered)". This is a medical device used for protection, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: The description 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 BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered) is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered) is intended to be worn by a ulsposable glove made or by a protect a surgical wound from contamination.
Product codes
KGO
Device Description
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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
Not Found
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 shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human figures, representing the department's focus on health and human well-being. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 12 1999
Mr. G. Baskaran Managinq Director Brightway Holding Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang Selangor Darul Ehsan MALAYSIA
Re : K991940 Brightway™ Brand Nitrile Surgical Gloves -Trade Name: Sterile (Powdered) Requlatory 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, 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. 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.
1
Page 2 - Mr. Baskaran
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 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runar
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
3.0 Indications for use
: BRIGHTWAY HOLDINGS SDN. BHD. Applicant K991940 .. 510(k) number : BRIGHTWAY™ Brand Nitrile Surgical Device name Gloves - Sterile (Powdered)
Indications for use:
BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered) is BRIGHT WAT -- Drand Nitrie Barger intended to be worn by a ulsposable glove made or by a 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection Cor and General Hospital I 510(k) Number