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

Device Description

The subiect device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic Poly-Isoprene material (not made from natural rubber latex). The gloves are manufactured using hand-specific molds (right and left hand). Each glove contains a beaded cuff to help reduce cuff roll-down during use.

AI/ML Overview

The document describes the Biogel® PI Micro Surgical Glove, a disposable, powder-free surgical glove made from synthetic Poly-Isoprene material. This device is a modification of the previously cleared Biogel® PI Surgical Glove (K050184), with changes in material thickness and the removal of a donning coating.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance (Results Summary)
Biocompatibility
Primary Skin Irritation	ISO 10993-10	Under the conditions of the study, not an irritant.
ISO Closed Patch Sensitization	ISO 10993-10	Under the conditions of the study, not a sensitizer.
Physical Characteristics
Dimensions: Length	ASTM D3577 (min. 245 mm for size 5½, 265 mm for size 6-9)	Length: 284 - 310 mm, meet the ASTM minimum requirements.
Dimensions: Width	ASTM D3577 (70 - 114 ± 6 mm)	Width: 71 - 116 mm, meet the ASTM requirement.
Dimensions: Thickness	ASTM D3577 (min. 0.10 mm)	Thickness: ≥ 0.30 mm, Exceeds the ASTM minimum requirement.
Physical Properties: Before ageing	ASTM D3577	Results meet requirements for rubber surgical gloves.
- Tensile strength	17 MPa min	28 - 29 MPa
- Stress at 500% elongation	7.0 MPa max. AQL 4.0	1.8 - 1.9 MPa
- Ultimate elongation	650 % min	1100 - 1120 %
Physical Properties: After accelerated ageing	ASTM D3577	Results meet requirements for rubber surgical gloves.
- Tensile strength	12 MPa min	22 - 24 MPa
- Ultimate elongation	490 % min	1100 - 1140 %
Freedom from holes	21 CFR 800.20 and ASTM D3577 (AQL 1.5)	Passed AQL 0.65, exceeds 21 CFR 800.20 and ASTM D3577 requirements.
Powder residual	ASTM D3577 (≤ 2.0 mg/glove)	Glove meets powder level requirements for "Powder-free" designation (results generated values below 2 mg of residual powder per glove).

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

The document specifies standards and tests (e.g., ISO 10993-10, ASTM D3577, ASTM D5151, ASTM D6124) were used to demonstrate performance. However, the specific sample sizes used for each test are not explicitly stated within this document. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).

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

This section is not applicable as the document describes performance testing based on engineering and material science standards (e.g., biocompatibility testing, physical properties, freedom from holes, powder residual), not on subjective expert assessment of an AI's output.

4. Adjudication method for the test set

This section is not applicable for the same reasons as #3. The performance is objectively measured against established standards.

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

This section is not applicable. This document describes a medical device (surgical glove) that functions as a physical barrier. It is not an AI-powered diagnostic or assistive tool, therefore, MRMC studies involving human readers or AI assistance are irrelevant.

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

This section is not applicable. This is a physical device, not an algorithm. The performance tests evaluate the glove itself.

7. The type of ground truth used

The ground truth for the performance evaluations are established by widely accepted international and national standards for medical devices and surgical gloves. Specifically:

Biocompatibility: ISO 10993-10
Dimensions & Physical Properties: ASTM D3577
Freedom from holes: 21 CFR 800.20 and ASTM D3577, tested according to ASTM D5151
Powder residual: ASTM D3577, tested using ASTM standard D6124

These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

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

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

This section is not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

September 4, 2014

Molnlycke Health Care, US, LLC Curtis D. Truesdale, RAC Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092

Re: K141719

Trade/Device Name: Biogel® PI Micro Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 4, 2014 Received: August 5, 2014

Dear Mr. Curtis D. Truesdale,

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. 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.

{1}------------------------------------------------

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); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141719

Device Name

Biogel PI Micro Surgical Glove

Indications for Use (Describe)

The Biogel Pl Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other co otaminarts

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Date Prepared:	August 4, 2014
Applicant:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877
Official Correspondent:	Curtis TruesdaleDirector, Regulatory Affairs of the AmericasTel: 678-250-7928Fax: 678-245-7746email: curtis.truesdale@molnlycke.com
Trade/Proprietary Names:	Biogel® PI Micro Surgical Glove
Regulation Name:	Surgeon's Glove
Device Class:	Class I
Regulation Number:	21 CFR 878.4460
Product Code:	KGO
Predicate Device Name(s):	Biogel® PI Surgical Glove (K050184)

Reason for 510(k) Submission:

This 510(k) supports a design modification made to the Biogel® PI Surgical Glove (reference code 408) that was previously cleared through 510(k) K050184. The design modifications consist of a reduction in material thickness from 0.62 + 0.06 mm to 0.42 + 0.04 mm and the removal of the donning coating. In order to commercially distinguish the modified version from the original glove, the modified glove is branded under the trade name Biogel® PI Micro Surgical Glove, reference code 485, and the original glove remains branded under the trade name Biogel PI Surgical Glove, reference code 408.

{4}------------------------------------------------

Description of Device:

Intended Use/Indication for Use:

Technological Characteristics:

Biogel® PI Micro Surgical Gloves were produced as a result of modifications made to the existing Biogel® PI Gloves that were previously cleared through 510(k) K050184. The gloves that were produced through these device modifications remain substantially equivalent in terms of technological characteristics, material formulation and intended use. The most notable technological differences between the subject and predicate Biogel® gloves are material thickness and donning coating. These technological characteristics and design modifications implemented for the subject device have been assessed and confirmed that the standard requirements that are appropriate for surgical gloves have been met. The following table is a summary of these technological characteristics in relation to standardized requirements.

Feature	Biogel® PI MicroSynthetic Polyisoprene SurgicalGlove	Biogel® Polyisoprene Non-latexSterile Powder-Free Surgeon's Glove(Trade name reflected in 510k filing)
	Subject Device(modified version of the predicate)	Predicate Device
510(k) clearance	K141719	K050184
Manufacturer	Mölnlycke	Mölnlycke
Regulation number	21CFR 878.4460	21CFR 878.4460
Regulation name	Surgeon's Glove	Surgeon's Glove
Regulatory class	Class I	Class I
Product code	KGO	KGO
Intended use	Powder-Free Surgeon's Glove	Powder-Free Surgeon's Glove
Indication for use	Biogel® PI Micro SyntheticPolyisoprene Surgical glove isa disposable device made ofpolyisoprene that is intended tobe worn on the hands, usuallyin surgical setting, to provide abarrier against potentiallyinfectious material and othercontaminants	Polyisoprene Non-Latex SterilePowder-Free Surgeon's Glove is adisposable device made ofpolyisoprene that is intended to beworn on the hands, usually in surgicalsetting, to provide a barrier againstpotentially infectious material andother contaminants
Material	Synthetic Polyisoprene	Synthetic Polyisoprene
Design	Single use	Single use
	Sterile	Sterile
	Powder-free	Powder-free
	Hand specific	Hand specific
	Beaded cuff sprayed with anantislip polychloroprene bandbelow the bead.	Beaded cuff sprayed with an antislippolychloroprene band below thebead.
Thickness	$0.42 \pm 0.04$ mm	$0.62 \pm 0.06$ mm
Coating	No	Yes
Colour	Natural	Natural
Sterilisation method	Radiation	Radiation
Sterility AssuranceLevel (SAL)	$10^{-6}$ SAL	$10^{-6}$ SAL
Dimensions & physicalproperties	Meets ASTM D3577	Meets ASTM D3577
Freedom from holes	AQL meets 21 CFR 800.20 andASTM D3577 requirements	AQL meets 21 CFR 800.20 andASTM D3577 requirements
Powder residual	Meets requirements of $\leq 2.0$mg/glove for Powder-freedesignation per ASTM D3577	Meets requirements of $\leq 2.0$mg/glove for Powder-free designationper ASTM D3577
Performance Test Data Summary - New Modified Device
Characteristics	Standard/Test/FDA Guidance	Results Summary
Biocompatibility :
Primary Skin Irritation	ISO 10993-10	Under the conditions of the study, notan irritant.
ISO Closed PatchSensitization	ISO 10993-10	Under the conditions of the study, nota sensitizer.
Physicalcharacteristics :
Dimensions	ASTM D3577	Length: 284 - 310 mm, meet theASTM minimum requirements of 245mm for size 5½ and 265 mm for size6 to 9.
		Width : 71 -116 mm, meet the ASTMrequirement of 70 - 114 ± 6 mm.
		Thickness : ≥ 0.30mm, Exceeds theASTM minimum requirement of 0.10mm.
Physical Properties	ASTM D3577	Results meet requirements for rubbersurgical gloves before and afteraccelerated ageing.
	Before ageing :	Average Values Before ageing :
	Tensile strength : 17 MPa min	Tensile strength : 28 - 29 MPa
	Stress at 500% elongation : 7.0MPa max.AQL 4.0	Stress at 500% elongation : 1.8 - 1.9Mpa
	Ultimate elongation : 650 %min	Ultimate elongation : 1100 -1120 %

	After accelerated ageing :	Average Values After acceleratedageing :
	Tensile strength : 12 MPa min	Tensile strength : 22- 24 MPa
	Ultimate elongation : 490 %min	Ultimate elongation : 1100 - 1140%

Freedom from holes	21 CFR 800.20 and ASTMD3577 tested according toASTM D5151	Passed AQL 0.65, exceeds 21 CFR800.20 and ASTM D3577requirements of AQL 1.5

Powder residual	ASTM D3577 tested usingASTM standard D6124	Glove meets powder levelrequirements for "Powder-free"designation per ASTM D3577 testingusing ASTM standard D6124.Results generated values below 2 mgof residual powder per glove.
Clinical testing :
Clinical data is notrequired

Summary of technological characteristics of the device compared to the predicate device

{5}------------------------------------------------

{6}------------------------------------------------

Conclusion:

The subject devices are substantially equivalent to the Biogel® Surgical Gloves previously 510(k) cleared (K050184) with respect to design, technological characteristics, and intended use and conformance to standard requirements.

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).