The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, 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

The proposed device, the Biogel® PI OrthoPro® Brown Surgical Glove is manufactured of non-latex (polyisoprene) colored with brown pigmentation. The Biogel® Pl OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years. The differences in the proposed glove and the predicate are as follows:

Addition of a Brown Colorant .
Thicker Glove .
New Former .
The glove former design used in the manufacture of this glove allows the Biogel® PI OrthoPro® Brown Surgical Glove to provide the user with this additional feature:
Slightly Curved Former with Independent/Displaced thumb ●

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Biogel® PI OrthoPro® Brown Surgical Glove:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from ASTM D3577 & 21 CFR 800.20)	Reported Device Performance
Primary Skin Irritation	Non-irritating	Gloves are non-irritating.
ISO Closed Patch Sensitization	No potential for sensitization	Gloves do not display any potential for sensitization.
Dimensions	Meet requirements of ASTM D3577	Gloves meet requirements of ASTM D3577.
Physical Properties	Meet requirements for rubber surgical gloves per ASTM D3577	Gloves meet requirements for rubber surgical gloves per ASTM D3577.
Freedom from Holes	Exceed requirements of 21 CFR 800.20 and ASTM D3577	Gloves exceed the requirements of 21 CFR 800.20 and ASTM D3577.
Powder Residual	Below 2mg of residual powder per glove (for "Powder-Free" designation per ASTM D3577 using ASTM D6142)	Results generated values below 2mg of residual powder per glove.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., how many gloves were tested for freedom from holes or dimensions). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The general phrasing "Results generated values" suggests data collection was performed to derive these values.

3. Number of Experts and Qualifications for Ground Truth

This device is a surgical glove, which falls under Class I medical devices and undergoes performance testing against established standards (ASTM, CFR). There is no indication that human expert review for establishing "ground truth" (in the typical sense of diagnostic imaging or clinical assessment) was required or used in these performance tests. The ground truth for these tests is defined by the objective metrics and thresholds within the cited ASTM and CFR standards.

4. Adjudication Method

Not applicable. As noted above, the assessment relies on objective measurement against predefined standards, not human interpretation requiring adjudication.

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

No. This type of study is not relevant for a surgical glove. MRMC studies are typically used to evaluate the effectiveness of diagnostic devices or AI algorithms in clinical decision-making with human readers.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical product (surgical glove), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on established industry standards and regulatory requirements, specifically:

ASTM D3577: Standard Specification for Rubber Surgical Gloves.
21 CFR 800.20: Regulations related to barrier integrity for gloves (implied for "Freedom from Holes").
ASTM D6142: Standard Test Method for Residual Powder on Medical Gloves.

These standards define the acceptable physical properties, dimensions, and integrity requirements for surgical gloves.

8. Sample Size for the Training Set

Not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The manufacturing process and quality control would involve ongoing testing and process adjustments, but not a dataset used for AI model training.

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Molnlycke Health Care. On the left side of the logo are five black circles of varying sizes clustered together. To the right of the circles is the text "MOLNLYCKE HEALTH CARE" in all capital letters.

KI12257

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

SEP 2 0 2011

Biogel® PI OrthoPro® Brown Surgical Glove

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

Date Prepared:	August 4, 2011
Applicant:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877
Official Correspondent:	Angela L. Bunn, RACDirector, Regulatory Affairs for the AmericasTel: 678-250-7930Fax: 678-245-7746e-mail: angela.bunn@molnlycke.com
Trade/Proprietary Name:	Biogel® PI OrthoPro® Brown Surgical Glove
Common Name:	Surgeon's Glove
Classification Name:	Surgeon's Glove
Device Class:	Class 1
Regulation Number:	21 CFR 878.4460
Product Code:	KGO
Predicate Device Name(s):	Poly-isoprene Non-Latex Sterile Powder-Free Surgeon's Glove(K050184)

Description of Device:

Addition of a Brown Colorant .
Thicker Glove .
New Former .

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA

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Image /page/1/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side. To the right of the circles, the words "MOLNLYCKE" and "HEALTH CARE" are printed in a sans-serif font, with "MOLNLYCKE" on top of "HEALTH CARE".

The glove former design used in the manufacture of this glove allows the Biogel® PI OrthoPro® Brown Surgical Glove to provide the user with this additional feature:

Slightly Curved Former with Independent/Displaced thumb ●

Intended Use/Indication for Use:

Technological Characteristics:

The Biogel® PI OrthoPro® Brown Surgical Glove is substantially equivalent to the Polyisoprene Non-Latex Sterile Powder-Free Surgeon's Glove (K050184). All of the assessed devices have similar indications for use, materials, product design, labeling claims and method of operation.

The difference in the proposed device, Biogel® PI OrthoPro® Brown Surgical Glove is the thickness, a slight change to the former and the addition of the brown colorant.

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA

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Image /page/2/Picture/0 description: The image shows the logo for Mölnlycke Health Care. The logo consists of a cluster of five black circles on the left side, arranged in a triangular shape. To the right of the circles, the text "MÖLNLYCKE" is stacked above "HEALTH CARE" in a simple, sans-serif font. The overall design is clean and professional, suggesting a focus on healthcare and medical products.

・

Table I -A below provides a clear detailed comparison of the proposed device (Biogel® Pl OrthoPro® Brown Surgical Glove) when compared to the predicate device.

Table 1-A
Substantial Equivalence Comparison Table of Product Features
Feature	Biogel® PI OrthoPro® BrownSurgical GloveProposed Device	Poly-Isoprene Non-Latex SterilePowder-Free Surgeon's GlovePredicate Device
510(k) Clearance	TBD	K050184
Manufacturer	Mölnlycke	Mölnlycke
Common Name	Surgeon's Glove	Surgeon's Glove
Classification #	Class I	Class I
ClassificationName	21 CFR 878.4460	21 CFR 878.4460
Product Code	KGO	KGO
Indication ForUse/Intended Use	The Biogel® PI OrthoPro® BrownSurgical Glove is a disposabledevice made of non-latex(polyisoprene) that is intended tobe worn on the hands, usually in asurgical setting, to provide a barrieragainst potentially infectiousmaterial and other contaminants.	Poly-Isoprene non-latex sterilepowder-free surgeon's glove isdisposable device made of Poly-Isoprene that is intended to be wornon the hands, usually in surgicalsettings, to provide a barrier againstpotentially infectious material andother contaminants.
Materials	Polyisoprene	Polyisoprene
Coated	Yes	Yes
Powder Free	Yes	Yes
Colored	Brown	Natural
SterilizationMethod andSterility AssuranceLevel (SAL)	Radiation10-6 SAL	Radiation10-6 SAL
Biocompatibility	Materials have been assessed basedto ISO 10993	Materials have been assessed basedto ISO 10993

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500
Norcross, GA 30092 USA

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Image /page/3/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles on the left side of the image. To the right of the circles, the words "MÖLNLYCKE" and "HEALTH CARE" are stacked on top of each other.

Performance Testing:

Test	Result
Primary Skin Irritation	Gloves are non-irritating.
ISO Closed Patch Sensitization	Gloves do not display any potential for sensitization.
Dimensions	Gloves meet requirements of ASTM D3577.
Physical Properties	Gloves meet requirements for rubber surgical glovesper ASTM D3577.
Freedom from Holes	Gloves exceed the requirements of 21 CFR 800.20 andASTM D3577.
Powder Residual	Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577 testing usingASTM standard D6142, Standard Test Method forResidual Powder on Medical Gloves. Results generatedvalues below 2mg of residual powder per glove.

Clinical Testing:

No clinical data was required.

Conclusion:

The Biogel® PI OrthoPro® Brown Surgical Glove met the technological and performance characteristics of ASTM D3577 and are substantially equivalent to predicate device indentified in this summary with respect to intended use, materials, and design.

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Angela L. Bunn Director, Regulatory Affairs for the Americas Molnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

SEP ? 0 ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Re: K112257

Trade/Device Name: Biogel® Pi OrthoPro® Brown Surgical Glove, Powder-Free, Sterile Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 25, 2011 Received: August 26, 2011

Dear Ms.Bunn:

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 ffor 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 If (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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Page 2 - Ms. Bunn

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 (reporting of medical device-related adverse events) (2) 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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQ/ffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cintheny D. Oner
L. D. Womack, D.D.S.

Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side of the image. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in a simple, sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line.

K112257

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Biogel® PI OrthoPro® Brown Surgical Glove, Powder-Free, Sterile

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabetta F. Laurie-Willen

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number: 《パススラフ

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA

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).