The Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

Device Description

The device in this 510(k) submission is intended for the Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove (Classification number 79KGO). The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made from Non-Latex synthetic rubber material, polvisoprene. Glove size is available from size 5.5 through 9.0 in a half size increment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Sterility	Meets ASTM D3577-00 requirements.
Freedom From Holes	Meets ASTM D3577-00 requirements.
Physical Properties	Meets ASTM D3577-00 requirements.
Physical Dimensions	Meets ASTM D3577-00 requirements.
Non-irritating	Tested and shown to be non-irritating using internationally recognized test methods.
Non-sensitizing	Tested and shown to be non-sensitizing using internationally recognized test methods.
Powder-free	Tested per ASTM D6124 and exceeds the requirements for "powder-free" nature.

Study Information

Due to the nature of this submission (a 510(k) for a medical glove, which is a Class I device), the study design is centered on bench testing and material property evaluation rather than clinical efficacy studies involving human subjects in the same way an AI diagnostic device would.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each specific test (e.g., how many gloves were tested for sterility, holes, etc.). However, industry standards like ASTM D3577-00 and ASTM D6124 would dictate specific sampling plans for these tests.
- Data Provenance: Implied to be from internal testing conducted by the manufacturer, SSL Americas, Inc., as part of their 510(k) submission. No information on country of origin of data (beyond the company location being in the US) or whether it was retrospective or prospective is provided, as it's not relevant for this type of device testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device. Ground truth for physical properties and biocompatibility of a surgical glove is established through standardized laboratory testing protocols (e.g., ASTM standards) and validated analytical methods, not by expert consensus on clinical images or outcomes.
Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or expert panels when establishing ground truth for subjective or complex diagnostic tasks. For objective physical and material property testing, results are determined by the test method itself.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical glove, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
The type of ground truth used:
- Standardized Test Specifications: The ground truth is defined by the specific requirements and methodologies outlined in the referenced ASTM standards (ASTM D3577-00 for sterility, freedom from holes, physical properties, physical dimensions, and ASTM D6124 for powder-free claims) and internationally recognized test methods for biocompatibility (non-irritating, non-sensitizing). These standards provide quantifiable criteria that the glove must meet.
The sample size for the training set:
- Not applicable. As this is not an AI device, there is no "training set." The development of the glove involved formulating and manufacturing it to meet the aforementioned physical and material specifications.
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device. The "ground truth" for the device's design and manufacturing revolves around adherence to established material science, engineering principles, and regulatory standards for medical devices.

Summary

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k) New Device Submission – Pl Glove

PART VIII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

< 020308

APR 0 3 2002

SUMMARY OF SAFETY AND EFFECTIVENESS FOR BIOGEL® SKINSENSE™ POLYISOPRENE SURGICAL GLOVES

Submitter Information 1.

SSL Americas, Inc. 3585 Engineering Drive, Suite 200 Norcross, Georgia 30092 Contact Person: Joyce Ning Telephone No. 770-582-2152

Device Name 2.

Classification Name: Non-Latex, Synthetic Surgical Glove Biogel® Skinsense™ Sterile, Powder-Free, Proprietary Name: Synthetic Polyisoprene Surgical Glove

Predicate Device 3.

Primary: Biogel® Neotch II Surgical Gloves (K000421)

Description of the Device 4.

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5. Indications for Use

Description of Safety and Substantial Equivalence 6.

The Biogel Skinscnsc™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Gloves are substantially equivalent to the Neotech II Powder-Free Synthetic Surgical Glove submitted and cleared under 510(k) under K000421. The only major difference is the use of synthetic polyisoprene instead of neoprenc polymer with its variations in the formulations. The results of the safety, effectiveness, and performance testing of the this proposed polyisoprene glove are detailed in this 510(k) submission and are summarized as follows:

The gloves meet all ASTM D3577-00 requirements for sterility, 1. freedom from holes, physical properties, and physical dimensions.
The gloves have been tested and shown to be non-irritating 2. and non-sensitizing under test conditions when evaluated in accordance with internationally recognized test methods.
The gloves have been tested per ASTM D6124 and exceed the 3. requirements to demonstrate "powder-free" in nature.

The results enclosed in this submission have demonstrated that the Biogel Skinsense, Powder-Free, Synthetic, Polyisoprene Surgical Glove is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of what appears to be an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joyce Ning Vice President, Regulatory Affairs SSL America's Incorporated 3585 Engineering Drive, Suite 200 P.O. Box 926090 Norcross, Georgia 30092-9214

APR 0 3 2002

Re: K020308

Trade/Device Name: Regent® Biogel® Skinsense™ Sterile, Powder-Free Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: January 28, 2002 Received: January 29, 2002

Dear Ms. Ning:

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.

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

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Page 2 - Ms. Ning

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally 1 edelar statues and regisments, including, but not limited to: registration Tou must comply with an the Piseling (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 807), idoling (21 cm ms (QS) regulation (21 CFR Part 820); and if requirences as set form in the quarty ajon 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 This letter will and w you to began india finding of substantial equivalence of your device to 510(K) prematics notification. - vice 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 II you desire specific ad novel 10 for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 80911638. Additionally, for questions on the promotion and Office of Comphiance wee, please contact the Office of Compliance at (301) 594-4639. advertising or your working entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation (210) it it it it is of the Division of Small Manufacturers, International and the Act may be obtained from and a sumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely you

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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510(k) New Device Submission - PI Glove

-Americas, Inc

PART V. INDICATIONS FOR USE STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.0

Indications for Use Statement

Applicant:	SSL-Americas, Inc.
510(k) Number (if known):	K020308
Device Name:	Regent Biogel ® Skinsense ™ Sterile, Powder-Free

Synthetic Polyisoprene Surgeon's Glove### Indications for Use:

The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds 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

Over-The-Counter Use OI

Chin S. Cin

on Sign-Off) of Dental, Infection Control, Coneral Hospital Devices ter Blumber

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).