BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT

K071565 · Molnlycke Health Care Us, LLC · KGO · Sep 10, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071565
• Device Name: BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Biogel® 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

Biogel Indicator Underglove is a sterile, powder-free, polymer-coated natural rubber latex surgical glove. Used in surgical settings by healthcare professionals to provide a barrier against infectious materials and contaminants. Device features low protein content (≤50 micrograms/gram) and non-pyrogenic properties. No complex inputs, processing, or outputs; device functions as a physical barrier.

Clinical Evidence

No clinical data was required; substantial equivalence established via bench testing.

Technological Characteristics

Natural rubber latex surgical glove; polymer coated; sterile; powder-free. Meets ASTM D3577 for dimensions, physical properties, and freedom from holes. Biocompatibility per ISO 10993-1. Endotoxin concentration <0.25EU/ml.

Indications for Use

Indicated for use as a protective barrier against infectious materials and contaminants for individuals in surgical settings.

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 (K980942)
• Eclipse, Non-pyrogenic, Latex, Powder-free, Glove (K060030)

Submission Summary (Full Text)

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| 1. | 510(k) SUMMARY<br>Applicant: | SEP 10 2007<br>Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway Suite 500<br>Norcross, GA 30092 |
|-----|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Steven Dowdley, RAC<br>Director of Regulatory Affairs, Molnlycke Health Care, US LLC<br>Tel.: [phone]<br>Fax: [phone] |
| | | or |
| | | Marcia K. Ash, RAC<br>MKA Consulting<br>Tel: [phone] |
| 3. | Device Name: | Biogel® Indicator™ Underglove with non-pyrogen statement |
| | Common Name:<br>Classification: | Surgical Glove (CFR 878.4461)<br>Class I |
| 4. | Predicate Device : | K980942 - Biogel® Indicator™ Underglove |
| | | K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove |
| 5. | Device Description: | The Biogel® Indicator™ Underglove is a sterile powder free,<br>polymer coated latex surgical glove. The glove contains 50<br>micrograms or less of total water extractable protein per gram. |
| 6. | Intended Use of the Device: | The Biogel® Indicator™ Underglove is a disposable device<br>made of natural rubber latex that is intended to be worn on the<br>hands, usually in a surgical setting, to provide a barrier against<br>potentially infectious material and other contaminants. |
| 7. | Technological Characteristics of the<br>Device: | The Biogel® Indicator™ Underglove characteristics are<br>summarized below as compared to ASTM requirements and to<br>the predicate devices. |
| | Characteristic<br>Dimensions<br>Physical Properties<br>Freedom from Holes<br>Biocompatibility<br>LALTest - final endotoxin<br>concentration | Standard<br>Meets ASTM D3577<br>Meets ASTM D3577<br>Meets ASTM D3577<br>Meets ISO 10993-1<br><0.25EU/ml |
| 8. | Performance Data | The performance data are summarized above. |
| 9. | Clinical Data | No clinical data was required. |
| 10. | Conclusion: | The Biogel® Indicator™ Underglove meets the<br>technological characteristics of ASTM D3577 and is<br>substantially equivalent to the predicate devices cited in this 510(k) summary. |

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three profiles facing to the right, representing the human aspect of the department's work.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2007

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

Re: K071565

Trade/Device Name: Biogel Powder-Free Latex Indicator Surgical Underglove, with Protein Content Labeling Claim (50micrograms or less) & with Non-Pyrogenic Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove

Regulatory Class: I Product Code: KGO

Dated: August 26, 2007

Received: August 28, 2007

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Chiu-Lin, Ph.D.

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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## 3.0 Indications for Use Statement:

Applicant: Molnlycke Heath Care US, LLC

510(k) Number: K071565

Biogel Powder-Free Latex Indicator Surgical Underglove, with Protein Content Device Name: Labeling Claim (50micrograms or less) & with Non-Pyrogenic Claim

## Indication for Use:

The Biogel® 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.

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

Prescription Use _ Per 21 CFR 801.109 Or Over-The-Counter _ . . . X

Shada A. Murphey 16
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071575