(60 days)
Not Found
None
No
The summary describes a sterile surgeon's glove and contains no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No
The device, a sterile surgeon's glove, is intended to prevent contamination during procedures, not to treat or diagnose a medical condition.
No
Explanation: The device is a sterile surgeon's glove, intended to prevent contamination during surgical procedures, not to diagnose a medical condition.
No
The device description clearly states it is a "Sterile Indicator Inner Surgeon's 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 prevent contamination between healthcare providers and patients during surgical procedures. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a sterile surgeon's glove. This is a physical barrier device.
- 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 of diseases or conditions
IVDs are used to perform tests in vitro (outside the body) on specimens derived from the human body to provide information for diagnostic purposes. A surgeon's glove is a medical device used in vivo (on the body) as a protective barrier.
N/A
Intended Use / Indications for Use
A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.
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
Surgeon or similar health care person
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | | 1998
Mr. Neil Anderson, RAC Director of Regulatory Affairs, U.S. Operations London International Group, Incorporated 2926 Columbia Hiqhway Dothan, Alabama 36303
Re : K980942 Regent Biogel Indicator Inner Surgical Glove Trade Name: Regulatory Class: I Product Code: KGO March 11, 1998 Dated: March 12, 1998 Received:
Dear Mr. Anderson:
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 of the Act. The general controls provisions 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. ಗಿ 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 regulation may result in regulatory 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. Anderson
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 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 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.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
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
Enclosure
2
APPENDIX II
Indications for Use
Applicant - London International Group (Regent Medical)
510(K) Number (if known) K980942
Device Name - Sterile Indicator Inner Surgeon's Glove
Indications for use:
A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.
Concurrence of CDRH Office of Device Evaluation
| (Division Sign-Off) | George A. Mills for Qin Jin PhD |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over the Counter _____________________________________________________________________________________________________________________________________________________________ OR
・・
Per 21 CFR 801.109