BIOGEL ORTHOPRO INDICATOR UNDERGLOVE

K101163 · Molnlycke Health Care USA · KGO · Nov 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101163
• Device Name: BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
• Applicant: Molnlycke Health Care USA
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex 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 natural rubber latex surgical glove; worn on hands to provide barrier against infectious materials/contaminants. Features slightly curved former with independent/displaced thumb for improved fit, feel, and comfort. Used in surgical settings by clinicians. Provides physical protection to the wearer and patient.

Clinical Evidence

No clinical data was required. Substantial equivalence established through bench testing including dimensions, physical properties, freedom from holes, biocompatibility (ISO 10993-1), LAL testing, and protein extractables (ASTM D5712).

Technological Characteristics

Natural rubber latex construction; Biogel coating. Dimensions and physical properties meet ASTM D3577. Biocompatibility per ISO 10993-1. Protein extractables per ASTM D5712. Features slightly curved former with independent/displaced thumb.

Indications for Use

Indicated for use as a disposable surgical glove for healthcare personnel to provide a barrier against infectious materials and contaminants.

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® Indicator Underglove (K071565 and K980942)
• Biogel® Orthopedic Surgical Glove (K071465)

Submission Summary (Full Text)

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1101163

NOV-2-3-2010-

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# Biogel® OrthoPro® Indicator® Underglove

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:

# April 8, 2010

Norcross, GA 30092 Registration number:

Owner/Operator Number:

Applicant:

Official Correspondent:

Trade/Proprietary Name:

Common Name:

Device Class:

Product Code:

Classification Name:

Regulation Number:

Predicate Device Name(s):

Angela L. Bunn, RAC Director, Regulatory Affairs of the Americas Tel: [phone] Fax: [phone] e-mail: [e-mail]

3004763499

9067000

Biogel® OrthoPro® Indicator® Underglove

Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500.

Surgeon's Glove

Surgeon`s Glove

Class I

21 CFR 878.4460

KGO

Biogel® Indicator Underglove (K071565 and K980942) Biogel® Orthopedic Surgical Glove (K071465)

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### Description of Device:

424 HEARE

The proposed device, the Biogel® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove 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 glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:

- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)

## Intended Use/Indication for Use:

The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex 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.

#### Technological Characteristics:

The Biogel® OrthoPro® Indicator® Underglove is substantially equivalent to the Biogel® Indicator" Underglove (K071565 and K980942) and Biogel" Orthopedic Surgical Glove (K071465).

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® OrthoPro® Indicator® Underglove is the thickness and a slight change to the former.

The Biogel® OrthoPro® Indicator® Underglove characteristics are summarized below as compared to ASTM requirements.

Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility LAL Test Results Protein Extractables

Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577 Meets ISO 10993-1 ASTM D7102 ASTM D5712

#### Performance Data:

The performance data are summarized above.

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# -Clinical Testing:

No clinical data was required.

## Conclusion:

Based on the performance testing, it can be concluded that the Biogel® OrthoPro® Indicator Underglove is equivalent to the Biogel® Indicator* Underglove (K071565 and K980942) and Biogel® Orthopedic Surgical Glove (K071465) predicates with respect to intended use, materials, design, and technological characteristics.

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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 Molnycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

NOV 2 3 2010

Re: K101163

Trade/Device Name: Biogel® OrthoPro® Indicator® Underglove with <50ug/g total water extractable protein statement Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 11, 2010 Received: November 12, 2010

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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/5/Picture/0 description: The image shows the logo for Molnlycke Health Care. On the left side of the logo are five spheres clustered together. To the right of the spheres is the text "MÖLNLYCKE HEALTH CARE" in a sans-serif font.

# INDICATIONS FOR USE

NOV 2 3 2010

510(k) Number (if known): K101163

#### Biogel® OrthoPro® Indicator® Underglove with ≤50μg/g total water Device Name: extractable protein statement

Indications For Use:

The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex 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 -------

AND/OR

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(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)

Eldith F. Clarence-Will

Division Sign-Off) 'ivision of Anesthesiology, General Hospital tection Control, Dental Devices

10(k) Number: K101163

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Mölnlycke Health Care US, LLC, Tel [phone] Peachtree Parkway, Suite 500 Fax [phone] Norcross, GA 30092 www.molnlycke.com