(70 days)
Not Found
Not Found
No
The summary describes surgical gloves, which are a physical barrier device and do not typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is a surgical glove, intended to protect a surgical wound from contamination, which is a barrier function, not a therapeutic intervention.
No
Explanation: The device, BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves, is intended to be worn for protection and does not gather or analyze data for diagnosis.
No
The device description clearly identifies the device as "Surgical Gloves," which are 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 protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description is for surgical gloves, which are physical barriers.
- 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, the BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
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 Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Mr. Victor J. Ragucci Chairman & CEO BarrierMed, Glove Company® 155 Technology Park Lake Mary, Florida 32746
Re: K061038
Trade/Device Name: BarrierPlus® Platinum Powder-Free Synthetic Polychloroprene Surgical Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 8, 2006 Received: June 13, 2006
Dear Mr. Ragucci:
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. Ragucci
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Claire Liu, Ph.D.
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
3.0 Indications for Use Statement:
INDICATIONS FOR USE
| Applicant: | BarrierMed Glove Co.® |
|---|---|
| ------------ | ----------------------- |
| 510(k) Number (if known) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | :
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
Device Name: BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
Indications For Use:
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala A. Mynher KS 6/23/06
nacthesincev.
Number: Kol 1038
- For a new submission, do NOT fill in the 510(k) number.
CONFIDENTIAL
BarrierMed Glove Co.
Page 6 of 15