(204 days)
Not Found
Not Found
No
The summary describes a standard surgical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a surgical glove intended to provide a barrier against infectious materials, not to treat or diagnose a disease or condition.
No
Explanation: The device is a surgical glove intended to provide a barrier against infectious materials, not to diagnose medical conditions.
No
The device is a physical glove made of latex, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "barrier against potentially infectious materials and other contaminants" and is "worn on the hands, usually in surgical setting". This describes a physical barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description "Powdered Latex Surgeon's Glove" further reinforces its nature as a physical barrier.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.
Product codes
KGO
Device Description
Powdered Latex Surgeon's Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical setting
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 seal of the Department of Health and Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, which is a symbol of medicine. The caduceus is composed of four wavy lines that form a stylized image of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beijing Reagent Latex Products, Company Limited C/O Mr. Ryan Barr Consultant Smith Associates 1676 Village Green, Suite A Crofton, Maryland 21114
APR 1 1 2007
Re: K062797
Trade/Device Name: Powdered Latex Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 21, 2007 Received: March 21, 2007
Dear Mr. Barr:
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 Eederal Register.
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Page 2 - Mr. Barr
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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
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Indications for Use
510(k) Number (if known): K062797
Device Name: Powdered Latex Surgeon's Glove
Indications for Use:
This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.
Prescription use (Part 21 CFR 801 Subpart D) AND/OR
Over - The - Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuli R. Murphy-ko
rance Annual Andrew Commend Mosperal, Juon Control, Dennal Devices
2(K) Number: A 062 797