(22 days)
Not Found
Not Found
No
The 510(k) summary describes a sterile surgical glove, a simple medical device, and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
This device is a surgical glove, which is a barrier to protect against contamination, not a device used to treat or diagnose a disease or condition.
No
This device is a surgical glove, which is intended for protection from contamination, not for diagnosing a medical condition.
No
The device is a surgical glove, which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the BRIGHTWAY™ Brand Nitrile Surgical Glove is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function, not a diagnostic test performed on a specimen.
The provided information clearly describes a physical barrier device used during surgery, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
BRIGHTWAY™ Brand Nitrile Surgical Glove - Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worry by operating room personnel to protect a surgical wound from contamination.
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 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)
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Mr. G. Baskaran Managing Director Managing Holdings Sdn. Bhd. Brightway nordings Batu Belah Lot 1539, Galangor Darul Ehsan MALAYSIA
BRIGHTWAY® Brand Nitrile Surgical Gloves каатаза Re : Trade Name: Sterile (Powder-Free) Regulatory Class: 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
the states by increased above and we have determined the we have reviewed your Section 510(K) noctr.roused market the device referenced above and wo works.
device is substantially equivalent (for the indications for device is substantially equivalenc (for marketed in interstate
use stated in the enclosure) to devices marketed in interstate use stated in the enclosure) to devices mant one of the commerce prior to May 28, 1976, the cheen that have been
Medical Device Amendments, or to devices that have been Medical Device Amendents, of Co devices biso incoment
reclassified in accordance with the provisions of the Federal reclassified in accordance with the provisay, therefore, Food, Drug, and Cosmetic Act (Acc). Too may ,
market the device, subject to the general controls provisions of the Act market the device, subject to the general os of the Act
of the Act. The general controls provisions of the Act
of the Act. The general controls registration, listing o of the Act. The general controls provision listing of
include requirements for annual registice, labeling, and include requirements for annual rose, labeling, and devices, good manufacturing pracesses,
prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II
n the see and becamelars TIT (Premarket Approval), it may If your device is class III (Premarket Approval), it may
(Special Controls) or class III (Premarket Approval), it may (Special Controls) or class lir (romerols. Existing major be subject to such addicional concrease tound in the Code of .
regulations affecting your device can be tound in the Code of ... A regulations arrecting your as , Parts 800 to 895 .
Federal Regulations, Title 21, Parts 800 to a rederal Regulations , Title Zi, Parcs 800 co operation with substantially equivalent deteimination devices: General
the Good Manufacturing Practice for Medical Through periodic the Good Manufacturing Practice Tourbat - through periodic
(GMP) regulation (21 CFR Part 820) and that, through periodic (GMP) regulation (2) CFR Farl over and Drug Administration (FDA) will
GMP inspections, the Food Esilyro to comply with the GMP GMP inspections, the FOOD and Dray names.
verify such assumptions. Failure to comply with addition verify such assumptions - Farrare co compar - In addition, FDA
regulation may result in regulatory action, your device in regulation may result in regulatory actions
may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Baskaran
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 requlations.
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".
Sincerety yours,
Susan Kumpa
(_Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
ರ್ಕರ
Enclosure
2
3.0 Indications for use
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| 510(k) number | : K991939 |
| Device name | : BRIGHTWAY™ Brand Nitrile Surgical |
| Glove - Sterile (Powder-Free) |
Indications for use:
BRIGHTWAY™ Brand Nitrile Surgical Glove - Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worry 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)
Prescription Use (Pct 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Olin S. lin
(Division Sign-Off Division of Dental, Info and General Hospit 510(k) Number
2