(40 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 protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as surgical gloves intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device is described as surgical gloves made of natural rubber, which are physical hardware devices, 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 protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is purely protective and barrier-based.
N/A
Intended Use / Indications for Use
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm 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 (comma separated list FDA assigned to the subject device)
KGO
Device Description
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber.
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): 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 black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, with wavy lines extending below them, possibly representing water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa Batu Belah 42100 Klang Selangor Darul Ehsan MALAYSIA
Re : K992020 Brightway™ Brand Latex Surgical Gloves -Trade Name: Sterile (Powdered) Regulatory Class: I KGO Product Code: June 11, 1999 Dated: 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 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 requlations 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) 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 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: Flease note: enro-affect any obligation you might have under submission accb noe arroom.
Sections 531 through 542 of the Act for devices under the Sections 351 children Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis lecter will arrow your was and the motification. The FDA described in your sie in promalence of your device to a legally Finding of subbeaneral oquiresults in a classification for your marketed predicate actre your device to proceed to the market.
If you desire specific advice for your device on our labeling II you debire bpoort 801 and additionally 809.10 for in regulation (21 of the s), please contact the Office of Itilo draghobere at (301) 594-4692. Additionally, for questions on Compriance at (50) deertising 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 Information on your of Small Manufacturers Assistance obcained from the Drvibion or 6.ma-2041 or (301) 443-6597 or at at its corr free namber (o://www.fda.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
3.0 Indications for use
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| 510(k) number | : K992020 |
| Device name | : BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered) Containing 150 ugm or less of water |
Indications for use:
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm 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.
Extractable protein per gram.
Chiu S. Lin
(Division S