BIOGEL (R) INDICATOR (R) UNDERGLOVE

K111413 · Molnlycke Health Care Us, LLC · KGO · Jan 30, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K111413
• Device Name: BIOGEL (R) INDICATOR (R) UNDERGLOVE
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jan 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Biogel® PI 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 Story

Disposable polyisoprene surgical glove; blue color; worn on hands in surgical settings. Provides barrier against infectious materials and contaminants. Manufactured with Biogel® coating and added surfactant. Used by surgeons and clinical staff to protect against cross-contamination. Benefit: barrier protection during surgical procedures.

Clinical Evidence

No clinical data was required; bench testing only.

Technological Characteristics

Polyisoprene material; blue pigmentation; Biogel® coating with added surfactant. Meets ASTM D3577 (dimensions, physical properties, freedom from holes), ISO 10993-1 (biocompatibility), and ASTM D7102 (LAL test).

Indications for Use

Indicated for use as a disposable surgical glove to provide a barrier against infectious materials and contaminants for individuals in a surgical setting.

Regulatory Classification

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.

Predicate Devices

• Biogel® PI Indicator® Underglove (K081180 - originally cleared under Skinsense Polyisoprene Underglove)

Submission Summary (Full Text)

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# (11413

JAN 3 0 2012

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# Biogel® PI Indicator® Underglove

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

Date Prepared:

August 25, 2011

Applicant:

Mölnlycke Health Care US, LLC

Angela L. Bunn, RAC

Tel: [phone]

5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 Registration number: 3004763499 Owner/Operator Number: 9067000

Director, Regulatory Affairs for the Americas

Official Correspondent:

Fax: [phone] e-mail: [e-mail] Trade/Proprietary Name: Biogel® PI Indicator Underglove Common Name: Surgeon's Glove Classification Name: Surgeon's Glove Device Class: Class 1 Regulation Nümber: 21 CFR 878.4460 Product Code: KGO Predicate Device Name(s): Biogel® PI Indicator® Underglove (K081180 - originally cleared under Skinsense Polyisoprene Underglove)

Description of Device:

The proposed device, the Biogel PI Indicator Underglove is manufactured of polyisoprene colored writh blue pigmentation. The Blogel PI Indicator Underglove is namifactured of the exact same material and coaled with *the Biogel® Coating which is used on the currently cleared device that has been legally marketed by M8lhycke Health Care for many years with the addition of a surfactant.

Intended Use/Indication for Use:

The Bloged® PI Indicator 4 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 containinants.

> Holnlycke Health Care 5550 Peachired Parkway. Suite 500 Norcross: GA 30092 USA

011 678 2511 7940 Fax [phone] Page 18 BP20 % ke.con

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Image /page/1/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of five circles on the left side, arranged in a pattern resembling a flower or a cell cluster. To the right of the circles, the text "MOLNLYCKE HEALTHCARE" is displayed in a simple, sans-serif font. The overall design is clean and professional, suggesting a focus on health and medical solutions.

#### Technological Characteristics:

The Biogel® Pl Indicator Underglove is substantially equivalent to the Biogel® PI Indicator Underglove (KOST 180 originally cleared under Skinsense Polyisoprene Underglove). The assessed devices have the same indications for. use, materials, product design, labeling claims and method of operation.

The only difference in the proposed device, Biogel® PI Indicator® Underglove is the addition of a surfactant.

The Bioget® Plandicator Underglove characteristics are summarized below as compared to ASTW requirements.

Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility LAL Test Results

Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577 Meets ISO 10993-1 ASTM D7102

#### Performance Data!

The performance data are summarized above.

#### Clinical Testing:

No clinical data was required:

#### Conclusion:

Based on the performance testing, it can be concluded that the Biogel® Indicator® Underglove is equivalent to the Biogel® Pl. Indicator® Underglove. (K031180 - originally cleared under Skinsense Poly isoprene Underglove) predicate with respect to intended use, materials; design, and technological characteristics:

> Mointycke Health Care 101 676-290 7900 5550 Peachtree Parkway, Suile 500 Fax [phone] Norce oss: GA 30092 USA Page 44 88 8 8 x 8 con

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human figures, with their heads tilted back and arms raised.

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

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

JAN 3 0 2012

Re: K111413

Trade/Device Name: Biogel® PI Indicator® Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: January 13, 2012 Received: January 17, 2012

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 (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.

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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) (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Anthony D. Watson

Anthony D. Watson, B.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/4/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of five circles on the left side, arranged in a pattern resembling a bunch of grapes. To the right of the circles, the text "MOLNLYCKE HEALTHCARE" is written in a simple, sans-serif font, with "MOLNLYCKE" on the top line and "HEALTHCARE" on the bottom line.

### INDICATIONS FOR USE

510(k) Number (if known):

K 1.1/1413.

Biogel® PI Indicator® Underglove Device Name:

Indications For Use:

The Biogel® PI 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) AND/OR

Over-The-Counter Use (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)

Elizabeth D. Clauser-Williams

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

510(k) Number:

111412

Page.1 of i

678 250 7784

Page & Bryglycke.com

olnlycke Health Care

Nortross, GA 30092 USA

50 Peachtree Parkway, Suil