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.

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.

AI/ML Overview

The provided text describes the SensiCare-C Synthetic Polyisoprene Powder-Free Surgical Gloves and their regulatory clearance, but it does not contain information about a study involving an AI/Machine Learning device or its performance criteria, ground truth, or expert review process.

The document is a 510(k) summary for a medical glove, focusing on its substantial equivalence to a predicate device and its compliance with relevant ASTM standards for physical properties, sterility, and freedom from holes.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input does not contain any of the following:

A table of acceptance criteria and reported device performance for an AI/ML system.
Sample sizes for test sets, data provenance, or details about training sets for an AI/ML system.
Information on experts used to establish ground truth or adjudication methods for an AI/ML system.
Details about Multi-Reader Multi-Case (MRMC) studies or standalone performance of an AI/ML system.
The type of ground truth used for an AI/ML system.

Summary

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NOV 1 2 2002

ANNEX II

K023236

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 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:

1. The gloves are substantially equivalent to the sterile SensiCare™ Synthetic Polyisoprene Powder-Free Surgical Gloves previously submitted and cleared under 510(k) number K002933.
1. 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.
1. 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.
1. The gloves have been tested per ASTM D6124, and are labeled as powder-free.

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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.

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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

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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

Regulation Number and Section

§ 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).