The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel® PI UltraTouch S Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Device Description

Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.

AI/ML Overview

The provided text describes a 510(k) premarket notification for surgical gloves and does not involve AI or algorithms. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), or ground truth establishment for an AI device.

The document is a regulatory submission for medical devices (surgical gloves) which are classified as Class I. The submission is focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the performance of an AI model against specific acceptance criteria.

The "acceptance criteria" discussed in the document relate to the physical and biocompatibility properties of the gloves, such as:

Physical Characteristics: Dimensions, tensile strength, elongation, freedom from holes, and powder residual. These are assessed against established ASTM (American Society for Testing and Materials) standards and FDA regulations (e.g., 21 CFR 800.20, ASTM D3577-09(2015), ASTM D5151-06(2015), ASTM D6124-06(2017)).
Biocompatibility: Primary skin irritation, ISO closed patch sensitization, and acute systemic toxicity. These are assessed against ISO 10993 standards.
Sterilization: Sterility Assurance Level (SAL) of 10-6.

Here's a breakdown of why your specific questions cannot be answered from the provided text, and what the text does provide regarding the device's performance:

Based on the provided text, the device is a surgical glove, not an AI or algorithm-based device. Therefore, the questions related to AI/algorithm performance, such as MRMC studies, standalone performance, training sets, and expert adjudication for ground truth of an AI model, are not applicable to this document.

The document describes the acceptance criteria and device performance for surgical gloves as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices.

Here's the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

The document presents a "Summary of Non-Clinical Testing" which effectively serves as the acceptance criteria and the reported performance against those criteria.

Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance (Subject Device: Biogel® PI UltraTouch S Surgical Glove / Biogel® PI UltraTouch S Indicator Underglove)
Biocompatibility:
Primary Skin Irritation (ISO 10993-10:2010)	Under the conditions of the study, not an irritant.
ISO Closed Patch Sensitization (ISO 10993-10:2010)	Under the conditions of the study, not a sensitizer.
Acute Systemic Toxicity Study (ISO 10993-11:2010)	Under the conditions of the study, no mortality or evidence of systemic toxicity from the extracts.
Physical Characteristics:
Dimensions (ASTM D3577-09(2015))	Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate.
Physical Properties (ASTM D3577-09(2015))	Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate.
Freedom from holes (ASTM D5151-06(2015) & ASTM D3577-09(2015), 21 CFR 800.20)	Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate.
Powder residual (ASTM D6124-06(2017) & ASTM D3577-09(2015))	Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate.

2. Sample sizes used for the test set and the data provenance

The document states "Summary of Non-Clinical Testing" but does not specify the sample sizes used for each of the tests (e.g., number of gloves tested for holes, number of animals for biocompatibility). The data provenance is implied to be from laboratory testing conducted to meet the specified ASTM and ISO standards, which are international. It's not retrospective or prospective in the clinical study sense; rather, it's laboratory testing of manufactured goods.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as this is for a physical device (surgical glove) and not an AI model. "Ground truth" here refers to established physical and biocompatibility standards, not expert interpretations of medical images or data.

4. Adjudication method for the test set

Not applicable. Testing involves conforming to predefined physical and chemical specifications, not subjective interpretation requiring adjudication.

5. 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 is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by internationally recognized standards and regulations for surgical gloves, specifically:

ASTM International standards (e.g., D3577, D5151, D6124) for physical properties.
ISO (International Organization for Standardization) standards (e.g., 10993 series) for biocompatibility.
FDA regulations (e.g., 21 CFR 800.20) for acceptable quality levels (AQL) for freedom from holes.

These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residual, AQL for holes, non-irritant response).

8. The sample size for the training set

Not applicable. This is not an AI device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device.

Summary

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My 24, 2019

Molnlycke Health Care, US LLC Leonard Stewart Regulatory Affairs Specialist 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092

Re: K190077

Trade/Device Name: Biogel® PI UltraTouch S Surgical Glove, Biogel® PI Ultra Touch S Indicator Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: February 28, 2019 Received: March 1, 2019

Dear Leonard Stewart:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For David Krause, PhD Acting Director Division of Infection Control and Plastic Surgery Office of Surgical & Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190077

Device Name

Biogel® PI UltraTouch S Surgical Glove and Biogel® PI UltraTouch S Indicator Underglove

Indications for Use (Describe)

The Bioge® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Bioge® PI UltraTouch S Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY (K190077)

for

Biogel® PI UltraTouch S Surgical Glove and Biogel®Pl UltraTouch S Indicator Underglove

Date Prepared:	May 22, 2019
Submission Sponsor:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877
Submission Correspondent:	Leonard StewartRegulatory Affairs SpecialistTel: 470-375-0178Fax: 678-245-7746email: leonard.stewart@molnlycke.com
Trade/Proprietary Names:	Biogel® PI UltraTouch S Surgical Glove and Biogel®PIUltraTouch S Indicator Underglove
Regulation Name:	Non-powered surgeon's glove
Common Name:	Surgeon's Glove
Classification Name:	Surgeon's Glove
Device Class:	Class I
Regulation Number:	21 CFR 878.4460
Product Code:	KGO
510(k) Submission Number:	K190077
Predicate Device Name(s):	Biogel® PI UltraTouch Surgical Glove (SKINSENSE®POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE, K050184),Biogel® Indicator Underglove (BIOGEL® INDICATOR ®UNDERGLOVE, K111413)

Description of Device:

Indications for Use:

The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polvisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

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	Summary of technological characteristics of the subject devicecompared to the predicate device
	(overglove)			(underglove)
	Biogel® PIUltraTouch SSurgicalGlove(SubjectDevice)	Biogel® PIUltraTouchSurgicalGlove(PredicateDevice)	Comment	Biogel® PIUltraTouch SIndicatorUnderglove(SubjectDevice)	Biogel® PIIndicatorUnderglove(PredicateDevice)	Comment
510(k)Number	K190077	K050184	-	K190077	K111413	-
Manufacturer	Mölnlycke	Mölnlycke	Identical	Mölnlycke	Mölnlycke	Identical
Regulationnumber	21CFR878.4460	21CFR878.4460	Identical	21CFR878.4460	21CFR878.4460	Identical
Regulationname	Surgeon'sGlove	Surgeon'sGlove	Identical	Surgeon'sGlove	Surgeon'sGlove	Identical
Regulatoryclass	Class 1	Class 1	Identical	Class 1	Class 1	Identical
Product code	KGO	KGO	Identical	KGO	KGO	Identical
Intended use	Powder-FreeSurgeon'sGlove	Powder-FreeSurgeon'sGlove	Identical	Powder-FreeSurgeon'sGlove	Powder-FreeSurgeon'sGlove	Identical
Indication foruse	Biogel® PIUltraTouch SSurgical Glove(Overglove) isa disposabledevice madeofpolyisoprene,that isintended to beworn on thehands, usuallyin surgicalsettings, toprovide a	Biogel® PIUltraTouchSurgicalglove(Overglove) Apowder-freesterilesurgeon'sglove is adisposabledevice madeofpolyisoprenethat isintended tobe worn on	Similar	Biogel® PIUltraTouch SIndicatorUnderglove is adisposabledevice made ofpolyisoprene,blue in colorthat is intendedto be worn onthe hands,usually insurgicalsettings, toprovide a	Biogel® PIIndicatorUnderglove isa disposabledevice madeofpolyisoprene,blue in colorthat isintended tobe worn onthe hands,usually in asurgicalsetting, toprovide a	Similar
	Summary of technological characteristics of the subject devicecompared to the predicate device
	potentiallyinfectiousmaterial andothercontaminants	the hands,usually insurgicalsettings; toprovide abarrieragainstpotentiallyinfectiousmaterials andothercontaminants		potentiallyinfectiousmaterial andothercontaminants	barrieragainstpotentiallyinfectiousmaterial andothercontaminants
Material	SyntheticPolyisoprene	SyntheticPolyisoprene	Identical	SyntheticPolyisoprene	SyntheticPolyisoprene	Identical
Design	Single use	Single use	Identical	Single use	Single use	Identical
	Sterile	Sterile	Identical	Sterile	Sterile	Identical
	Powder-free	Powder-free	Identical	Powder-free	Powder-free	Identical
	Hand specific	Hand specific	Identical	Hand specific	Hand specific	Identical
	Beaded Cuff	Beaded cuff	Identical	Beaded cuff	Beaded cuff	Identical
Coating	Yes	Yes	Identical	Yes	Yes	Identical
Color	Straw(Natural)	Straw(Natural)	Identical	Blue	Blue	Identical
Sterilizationmethod	Radiation	Radiation	Identical	Radiation	Radiation	Identical
SterilityAssuranceLevel (SAL)	10-6 SAL	10-6 SAL	Identical	10-6 SAL	10-6 SAL	Identical
Dimensions& physicalproperties	Meets ASTMD3577-09(2015)	Meets ASTMD3577-09(2015)	Identical	Meets ASTMD3577-09(2015)	Meets ASTMD3577-09(2015)	Identical
Freedomfrom holes	AQL meets 21CFR 800.20and ASTMD3577-09(2015)requirements	AQL meets21 CFR800.20 andASTMD3577-09(2015)requirements	Identical	AQL meets 21CFR 800.20and ASTMD3577-09(2015)requirements	AQL meets21 CFR800.20 andASTMD3577-09(2015)requirements	Identical
Powderresidual	Meetsrequirementsof ≤ 2.0mg/glove forPowder-freedesignationper ASTMD3577-09(2015)	Meetsrequirementsof ≤ 2.0mg/glove forPowder-freedesignationper ASTMD3577-09(2015)	Identical	Meetsrequirements of≤ 2.0 mg/glovefor Powder-freedesignation perASTM D3577-09(2015)	Meetsrequirementsof ≤ 2.0mg/glove forPowder-freedesignationper ASTMD3577-09(2015)	Identical

Technological Characteristics:

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Summary of Non-Clinical Testing:

Summary of Non-Clinical Testing
	Standard/Test/FDA Guidance	Biogel® PIUltraTouch SSurgical Glove(Subject Device)	Biogel® PIUltraTouch SIndicatorUnderglove(Subject Device)
Biocompatibility:
Primary SkinIrritation	ISO 10993-10:2010 Biologicalevaluation of medical devices —Part 10: Tests for irritation and skinsensitization	Under the conditions of the study, not anirritant.
ISO ClosedPatchSensitization	ISO 10993-10:2010 Biologicalevaluation of medical devices —Part 10: Tests for irritation and skinsensitization	Under the conditions of the study, not asensitizer.
Acute SystemicToxicity Study	ISO 10993-11:2010 Biologicalevaluation of medical devices —Part 11: Tests for systemic toxicity	Under the conditions of the study, nomortality or evidence of systemic toxicityfrom the extracts.
Physicalcharacteristics:
Dimensions	ASTM D3577- 09(2015)Standard Specification forRubber Surgical Gloves	Meets ASTM D3577-09(2015) requirementsfor length, width, and thickness. Identical topredicate.
PhysicalProperties	ASTM D3577- 09(2015)Standard Specification forRubber Surgical Gloves	Meets ASTM D3577-09(2015)requirements for tensile strength andelongation at break before and afteraccelerated aging. Identical to Predicate.
Freedom fromholes	ASTM D5151-06(2015) StandardTest Method for Detection of Holesin Medical GlovesASTM D3577- 09(2015) StandardSpecification for Rubber SurgicalGloves	Exceeds 21 CFR 800.20 and ASTMD3577-09(2015) requirements of AQL1.5. Identical to predicate.
Powder residual	ASTM D6124-06(2017) StandardTest Method for Residual Powderon Medical GlovesASTM D3577- 09(2015) StandardSpecification for Rubber SurgicalGloves	Meets powder level requirements for"Powder-free" designation per ASTMD3577-09(2015). Identical to predicate.
Clinical Data Summary - Subject Device (modified version of the predicate)
Clinical testing	Clinical data is not required. Identical to predicate.

Conclusion:

Based on the Indication for Use, technological characteristics, and non-clinical performance data, Bioge®® Pl UltraTouch S Surgical Glogel® Pl UltraTouch S Indicator Underglove (K190077) are as safe, as effective, and perform as well as or better than the legally marketed predicate devices Bioge®® PI UltraTouch Surgical Glove (K050184) and the Bioge®® PI Indicator Underglove (K111413).

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).