(180 days)
Not Found
None
No
The device description and intended use clearly define a surgeon's glove, which is a physical barrier and does not involve AI/ML technology. The "Mentions AI, DNN, or ML" field is also "Not Found".
No
A surgeon's glove is intended to protect a surgical wound from contamination, which is a preventive measure rather than a treatment for a disease or condition.
No
Explanation: The intended use of the device, a surgeon's glove, is to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a "surgeon's glove," which is a physical, hardware device made of rubber. There is no mention of software as the primary component or function.
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 physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the physical barrier function of the glove.
- 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, a surgeon's glove, as described, falls under the category of a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, depicted with stylized lines to suggest feathers and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1997
Uniject Gloves Ltd. ·C/O Dr. Syed Baber 2920 Mumphrey Drive Chal Mette, Louisiana 70043
Re : K970160 Uniject Powdered Latex Surgical Gloves Trade Name: Requlatory Class: I Product Code: KGO Dated: April 29, 1997 Received: May 1, 1997
Dear Dr. Baber:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
1
Page 2 - Dr. Baber
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
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
Image /page/2/Picture/0 description: The image shows a black and white symbol that appears to be a stylized letter 'U' within a circle. Inside the 'U', there's a depiction of a hand with four fingers, with the thumb seemingly tucked in. The overall design is simple and graphic, suggesting it could be a logo or an emblem.
GLOVES LTD. NIJECT
JEBEL ALTRER ZLAS
్రాంగ్రెస్ గ్రామం
INCORPORATED IN BRITISH JIRGIN ISLAND __
INDICATIONS FOR USE
: UNIJECT GLOVES LTD: JEBEL ALI, DUBAI (U.A.E) Applicant
510 K Number : K 9700160
: UNIJECT SURGICAL GLOVES Device Name
: A surgeon's glove is device made of natural or Indications for use synthetic rubber intended to be worn by the 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 Officer of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
And General Hospital Devices
..510(k) Number __
Prescription Use
Per 21 CFR 801, 109
OR
Over-The-Counter __
(Curral Format 1-2-95)
:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
P.O. BOX 16901, JEBEL ALI, DUBAI - U.A.E. TEL. : 00971-4-815235 FAX. : 00071-4-815232
ו- יריי יי
ص.ب : 1 : 1 : 1 : حجل عقل ، لدسو - ا .ع. ع. تلیغون : ۱۳۵۲۴۵ ۱۱۵۲۴۰ : ۰۰ : ۰ . هایکس :