SKINSENSE POLYISOPRENE UNDERGLOVE

K081180 · Molnlycke Health Care Us, LLC · KGO · Aug 26, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081180
• Device Name: SKINSENSE POLYISOPRENE UNDERGLOVE
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Skinsense Polyisoprene Underglove is a disposable device made of non-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

Skinsense Polyisoprene Underglove is a sterile, powder-free, polymer-coated surgical glove. Worn on hands in surgical settings by healthcare personnel to provide a barrier against infectious materials and contaminants. Device is disposable. No complex processing or software involved.

Clinical Evidence

No clinical data was required.

Technological Characteristics

Material: Polyisoprene (non-natural rubber latex). Polymer coated. Sterile, powder-free. Meets ASTM D3577-01-ae2 standards for dimensions, physical properties, and biocompatibility (cytotoxicity, skin irritation, LAL test <0.25EU/ml).

Indications for Use

Indicated for use as a disposable hand barrier in surgical settings to protect 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.

Submission Summary (Full Text)

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Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092

Koyllso

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## 510(k) SUMMARY

- 1. Applicant:
- 2. Contact Person:
- 3. Device Name: Common Name: Classification:
- 4. Predicate Device : Device Description:
- 6. Intended Use of the Device:

7. Technological Characteristics of the Device:

Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility Cytotoxiciity Study ISO Skin Irritation Study LAL Test

8. Performance Data

- 9. Clinical Data
- 10. Conclusion:

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

Steven Dowdley, RAC Director of Regulatory Affairs Tel.: [phone] Fax:

Skinsense Polyisoprene Underglove Surgical Glove (CFR 878.4461) Class I

The Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

The Skinsense Polyisoprene 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.

The Skinsense Polyisoprene Underglove characteristics are summarized below as compared to ASTM requirements and to the predicate devices.

Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577

Pass Pass <0.25EU/ml. The performance data are summarized above.

No clinical data was required.

The Skinsense Polyisoprene Underglove meets the technological characteristics of ASTM D3577-01-ae2 and is substantially equivalent to the predicate devices identified in sited in this 510(k) summary.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Dowdley Director of Regulatory Affairs Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

AUG 2 6 2008

Re: K081180

Trade/Device Name: Skinsense Polyisoprene Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: August 13, 2008 Received: August 15, 2008

Dear Mr. Dowdley:

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.

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

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

CluG

Chiu Lin. Ph.D. 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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Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092

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## INDICATION FOR USE

Applicant: Molnlycke Heath Care US, LLC

510(k) Number:

Device Name: Skinsense Polyisoprene Underglove

## Indication for Use:

The Skinsense Polyisoprene Underglove is a disposable device made of non-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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ***_***__ Or Over-The-Counter X

Per 21 CFR 801.109

Shule M. Mymberyke

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

510(k) Number: K081180