(46 days)
Not Found
No
The document describes a surgical glove and does not mention any AI or ML capabilities.
No
The device is a surgical glove intended to provide a barrier for protection, not to treat or cure a disease or condition.
No
The device is a surgical glove, which is intended as a barrier for protection against microbial migration and contamination, not for diagnosing any medical condition.
No
The device description clearly states it is a "sterile, synthetic rubber latex surgical glove," which is a physical hardware device. The performance studies also focus on physical properties and testing of the glove material.
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 "disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon." This describes a physical barrier device used during a medical procedure.
- Device Description: The description reinforces this, stating it's a "sterile, synthetic rubber latex surgical glove" 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."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
The function of a surgical glove is to provide a physical barrier, which is not the purpose of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The device in this 510(k) submission is the SensiCare -C Synthetic Polyisoprene Powder-free Surgical Glove (Classification number 79KGO). The SensiCare C Synthetic Polyisoprene 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
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical 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 gloves are substantially equivalent to the sterile SensiCare™ Synthetic Polyisoprene Powder-Free Surgical Gloves previously submitted and cleared under 510(k) number K002933.
- The gloves meet all ASTM D3577-01a62, 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 nonsensitizing under test conditions when evaluated in accordance with internationally recognized test methods.
- The gloves have been tested per ASTM D6124, and are labeled as powder-free.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 1 2 2002
ANNEX II
510 (K) SUMMARY . SAFETY AND EFFECTIVENESS SUMMARY
(in accordance with SMDA 1990)
SENSICARE®-C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES Classification Name: Surgeon's Glove, Type 2 (21 CFR 878.4460)
(Lavender Color)
The device in this 510(k) submission is the SensiCare -C Synthetic Polyisoprene Powder-free Surgical Glove (Classification number 79KGO). The SensiCare C Synthetic Polyisoprene 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 Polyisoprene Powder-Free Surgical Gloves are substantially
equivalent to the SensiCare™ Synthetic Polyisoprene Powder-Free Surgical Gloves previou submitted and cleared under 510(k) number K002933. The only difference is that this submission is for the inclusion of colorants in the glove substrate. The safety and effectiveness of the device is maintained. The results of the safety, efficacy, and performance testing of the SensiCare"-C Synthetic Polyisoprene Powder-Free Surgical Gloves are detailed in this 510(k) submission and are summarized as follows:
-
- The gloves are substantially equivalent to the sterile SensiCare™ Synthetic Polyisoprene Powder-Free Surgical Gloves previously submitted and cleared under 510(k) number K002933.
-
- The gloves meet all ASTM D3577-01a62, 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 nonsensitizing under test conditions when evaluated in accordance with internationally recognized test methods.
-
- The gloves have been tested per ASTM D6124, and are labeled as powder-free.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2002
Mr. Roy E. Moser Manager, Corporate Regulatory Affairs · Maxxim Medical, Incorporated 4750 118" Avenue North Clearwater, Florida 33717
Re: K023236
Trade/Device Name: SensiCare-C Synthetic Polysoprene Powder-Free Surgical Gloves (Lavender Color) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgical Gloves Regulatory Class: I Product Code: KGO Dated: September 23, 2002 Received: September 27, 2002
Dear Mr. Moser:
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 vour 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.
2
Page 2 – Mr. Moser
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
INDICATIONS FOR USE STATEMENT
Maxxim Medical Inc. Applicant:
510(k) Number: K 023236
SensiCare-C Synthetic Polysoprene Power-Free Surgical Gloves Device Name: (Lavender color)
Indications for use: A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon.
Qim S. Cin
Division Sign.
510(k) Number: K023236