(289 days)
Not Found
Not Found
No
The summary describes a standard surgical glove and explicitly states that AI, DNN, or ML are "Not Found".
No
A surgeon's glove is a barrier device used for protection, not for treating a disease or condition.
No
Explanation: The "Intended Use" states that the device is to protect surgical wounds from contamination and prevent contamination between personnel and patients, which is a protective function, not a diagnostic one. There is no mention of the device being used to identify, detect, or monitor a disease or condition.
No
The device description clearly states it is "Powder Free SterikSurgeon's Gloves," which are a physical, hardware medical device. There is no mention of software functionality.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Surgeon's Gloves Function: The intended use of Surgeon's Gloves is to create a physical barrier to prevent contamination during surgery. They are a protective barrier device, not a device that analyzes biological specimens to provide diagnostic information.
The provided information clearly describes a physical barrier device used for protection, not a device for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contaimination between operating room personnel and patient.
Product codes
KGO
Device Description
Powder Free SterikSurgeon's Gloves
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / operating room
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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1997
Mr. Chenq Ko Lin President Shang Ho Industrial Corp Ltd. 4-5, Nan Pei 1st Rd Chiang Li, Tachia, Taichunq Hsien Taiwai, R.O.C.
Re : K970795 Trade Name: Shang Ho Powder Free Latex Surqical Gloves Requlatory Class: I Product Code: KGO Dated: September 30, 1997 Received: September 30, 1997
Dear Mr. Lin:
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 Regulations, Title 21, Parts 800 to 895. ਜੋ 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 - Mr. Lin
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 beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 Radiological Health
Enclosure
2
Attachment M
Indication For Use Statement
510K Number (if known): Applied for Device Name: Powder Free SterikSurgeon's Gloves Indications For Use:
A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contaimination between operating room personnel and patient.
Shang Ho Industrial Corp. Ltd.
$\times$ Cheng Ko Lin
Cheng Ko Lin
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | ||
| Division of Dental, Infection Control, | ||
| and General Hospital Devices | ||
| 510(k) Number | K970795 | |
| Prescription Use | OR | Over-The-Counter Use X |
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)