BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE

K053441 · Regent Medical Americas, LLC · KGO · Apr 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053441
• Device Name: BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
• Applicant: Regent Medical Americas, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Biogel Latex Sterile Powder-Free Surgeon's Glove; disposable natural rubber latex device; worn on hands by surgeons/healthcare personnel in surgical settings; provides barrier against infectious materials and contaminants; reduces risk of dermatitis and protein-related allergic reactions via low protein content labeling claim (50 micrograms or less); manual application; no electronic components or software.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Natural rubber latex material; powder-free; sterile; disposable; surgeon's glove form factor. Designed for low dermatitis potential and low protein content (≤ 50 micrograms).

Indications for Use

Indicated for use as a protective barrier on the hands of healthcare personnel in surgical settings to prevent cross-contamination between clinician and patient.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2006

Ms. Kathleen Harris Global Regulatory Manager Regent Medical Americas, LLC 3585 Engineering Drive, Suite 250 Norcross, Georgia 30092

Re: K053441

Trade/Device Name: Biogel Latex Sterile Power-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 20, 2006 Received: March 22, 2006

Dear Ms. Harris:

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 - Ms. Harris

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,

Sutite y. Michael Onz-D.
Chia 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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## Indications for Use

510(k) Number (if known): K053441

Device Name: Device Name: Biogel Latex Sterile Powder-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 micrograms or less)

Indications For Use:

A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

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)

Shule R. Murphy, MD 4/18/04

nesthesiology, General Hos

510(k) Number: K 053441

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