(83 days)
Not Found
Not Found
No
The 510(k) summary describes surgical gloves, which are a physical barrier device and do not incorporate software or data processing capabilities typically associated with AI/ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, performance studies, or metrics relevant to AI/ML algorithms.
No
The device is a surgical glove, intended to provide a barrier against contaminants, not to treat or diagnose a disease or condition.
No
The device is a surgical glove, which provides a barrier against contaminants and is not used for diagnosing medical conditions.
No
The device is a physical surgical glove, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a barrier against infectious materials and contaminants during surgical procedures. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical glove, which 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 treatment decisions based on sample analysis.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A Powder Free Surgeon's Glove made of synthetic material. It is intended to be worn by health.care personnel, usually in surgical settings to provide a barrier against potentially infectious materials and other contaminants.
Product codes
KGO
Device Description
Powder Free Sterile Nitrile Surgical Gloves (Blue)
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
health.care personnel, usually in surgical settings
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 stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2006
Mr. Kuan Kam Hon Managing Director Hartalega Sdn. Bhd. Lot 9, Jalan Kuang Bulan, Taman Kepong Industrial Estate, 52100 Kuala Lumpur, MALAYSIA
Re: K062950
Trade/Device Name: Powder Free Sterile Nitrile Surgical Gloves (Blue) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 12, 2006 Received: December 15, 2006
Dear Mr. Kam Hon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 – Mr. Kam Hon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
3. Indication for Use Statement:
Indication For Use
510(k) Number (if known): K062950
Device Name: Powder Free Sterile Nitrile Surgical Gloves (Blue)
Indications for Use:
A Powder Free Surgeon's Glove made of synthetic material. It is intended to be worn by health.care personnel, usually in surgical settings to provide a barrier against potentially infectious materials and other contaminants.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy 140
I of Anesties 174 General Hos Control. Dunal Dev