SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES by MAXXIM MEDICAL

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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the SensiCare™ Synthetic Powder-Free Surgical Gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material/Design: Sterile, synthetic rubber latex surgical glove	The device described is the SensiCare™ Synthetic Powder-Free Surgical Glove, which is a sterile, synthetic rubber latex surgical glove. The only differences from the predicate are the use of synthetic polyisoprene instead of synthetic neoprene and variations processes and packaging.
Barrier Protection: 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.	This is the intended use of the device, aligning with the definition of a surgeon's glove.
ASTM D3577-98 Requirements: Meets requirements for sterility, freedom from holes, physical properties, and physical dimensions.	"The gloves meet all ASTM D3577-98, requirements for sterility, freedom from holes, physical properties, and physical dimensions."
21 CFR 800.20 Requirements: Meets requirements for freedom from pinholes.	"The gloves meet the requirements of 21 CFR 800.20 for freedom from pinholes."
Non-Irritating and Non-Sensitizing:	"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."
Powder-Free (ASTM D6124-97):	"The gloves have been tested per ASTM D6124-97, and are labeled as powder free."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in the summary provided.
The data provenance is also not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of product testing for regulatory clearance, it would typically be prospective testing conducted by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing appears to be based on standardized ASTM and CFR requirements, which are objective measurements rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective, standardized tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. The document describes testing of a physical device against established standards, not an AI system or human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical product (surgical gloves), not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used is based on objective, standardized measurements and requirements as defined by:

ASTM D3577-98 (for sterility, freedom from holes, physical properties, and physical dimensions)
21 CFR 800.20 (for freedom from pinholes)
Internationally recognized test methods (for non-irritation and non-sensitization)
ASTM D6124-97 (for powder-free status)

8. Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

Summary

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K983982

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 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.
1. 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.
1. 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

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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

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INDICATIONS FOR USE

Applicant:	Maxxim Medical, Inc.
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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

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).