(176 days)
Not Found
No
The 510(k) summary describes a surgical glove and its performance testing against established standards, with no mention of AI or ML technology.
No
The device is a surgical glove, which is a barrier device used for protection against contamination, not for treating a disease or condition.
No
The device is a surgical glove intended to protect a surgical wound from contamination and act as a barrier against microbial migration. It is not used to diagnose a medical condition.
No
The device description clearly identifies the device as a physical surgical glove made of synthetic rubber, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description reinforces the barrier function of the glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical properties, sterility, and safety of the glove as a barrier, not on diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The device in this 510(k) submission is the SensiCare™ Synthetic Powder-Free Surgical Glove (Classification number 79KGO). The SensiCare™ Synthetic Powder-Free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the safety. .icacy, and performance testing of the SensiCare™ Synthetic Powder-Free Surgical Gloves are detailed in this 510(k) submission and are summarized as follows:
- The gloves meet all ASTM D3577-98, requirements for sterility, freedom from holes, physical properties, and physical dimensions. The gloves meet the requirements of 21 CFR 800,20 for freedom from pinholes.
-
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing under test conditions when evaluated in accordance with internationally recognized test methods.
-
- The gloves have been tested per ASTM D6124-97, and are labeled as powder free,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 description: The image shows a handwritten date, "5/4/99". The numbers are written in a simple, slightly slanted style. The slashes separating the month, day, and year are vertical lines. The handwriting appears to be done with a pen or marker, and the image is in black and white.
Image /page/0/Picture/1 description: The image shows the logo for Maxxim Medical. The logo is in black and white and features the word "MAXXIM" in large, bold letters. Below the word "MAXXIM" is the word "MEDICAL" in smaller letters.
November 4. 1998
Maxxim Medical, Inc.
10300 49th Street North Clearwater, FL 33762 Phone: 727-561-2100 Fax: 727-561-2180
510(K) SUMMARY OF SAFETY AND EFFICACY -SENSICARE™ SYNTHETIC POWDER-FREE SURGICAL GLOVES / JSepore o c Classification Name: Surgeon Glove, Type 2 (21 CFR 878.4460)
The device in this 510(k) submission is the SensiCare™ Synthetic Powder-Free Surgical Glove (Classification number 79KGO). The SensiCare™ Synthetic Powder-Free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.
The SensiCare™ Synthetic Powder-Free Surgical Gloves are substantially equivalent to the Neolon™ Powder-Free Non-Latex Surgical Glove submitted and cleared under 510(k) number K933062. The only differences are the use of vnthetic polyisoprene instead of synthetic neoprene and variations processes and packaging. ese are not considered to be significant to the safety or effectiveness of the results of the safety. .icacy, and performance testing of the SensiCare™ Synthetic Powder-Free Surgical Gloves are detailed in this 510(k) submission and are summarized as follows:
- The gloves meet all ASTM D3577-98, requirements for sterility, freedom from holes, physical 1. properties, and physical dimensions. The gloves meet the requirements of 21 CFR 800,20 for freedom from pinholes.
-
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing under test conditions when evaluated in accordance with internationally recognized test methods.
-
- The gloves have been tested per ASTM D6124-97, and are labeled as powder free,
If you have any questions, please contact me at (727) 556-6190. I can also be reached at the following address:
Joyce T. Moody Maxxim Medical 4750 118th Avenue North Clearwater, FL 34622
Sincerelv.
Joyce T. Moody
Jovce T. Moodv re President - Regulatory Affairs/Quality Assurance
CASE MANAGEMENT DIVISION
4750 118TH AVENUE NORTH • CLEARWATER, FL 34622-0009 • 813/571-3717 • FAX: 813/573-3506
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or bird, with stylized lines forming its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 MAY
Ms. Joyce T. Moody Vice President, Regulatory Affairs/Quality Assurance Maxxim Medical, Incorporated Procedure Based Case Management Division
4750 118th Avenue North Clearwater, Florida 34622
Re: K983982 SensiCare™ Synthetic Powder-Free Surgical Trade Name: Gloves Requlatory Class: I Product Code: KGO Dated: April 17, 1999 Received: April 22, 1999
Dear Ms. Moody:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Moody
This letter will allow you to begin marketing your device as InIS ited in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device 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 regaracion (ir devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriance at (502) deertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regatation" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obearied from one umber (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
3
INDICATIONS FOR USE
| Applicant: | Maxxim Medical, Inc. |
|---|---|
| ------------ | ---------------------- |
K983982 510(k) Number:
Maxxim Medical SensiCare™ Synthetic Powder-Free Surgical Gloves Joseprene Device Number:
Indications for Use:
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
Over-The Counter
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 983982