BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE

K053442 · Regent Medical Americas, LLC · KGO · Mar 7, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053442
• Device Name: BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
• Applicant: Regent Medical Americas, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 7, 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 Poly-Isoprene 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

Disposable sterile surgeon's glove; composed of Poly-Isoprene; intended for use in surgical settings by healthcare professionals. Functions as a physical barrier to protect both patient and clinician from infectious materials and contaminants during surgical procedures. Device is non-pyrogenic; powder-free to reduce potential for adverse reactions. Used in operating rooms or clinical environments; worn on hands.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Poly-Isoprene. Form factor: Sterile, powder-free surgeon's glove. Non-pyrogenic. Single-use disposable.

Indications for Use

Indicated for use as a disposable, sterile, powder-free surgeon's glove made of Poly-Isoprene to be worn on the hands in surgical settings 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2006 MAR

Ms. Kathleen Harris Regent Medical Americas, Limited Liability Company 3585 Engineering Drive, Suite 250 Norcross, Georgia 30092

Re: K053442

K005442
Trade/Device Name: Biogel Skinsense Poly-Isoprene Powder-free Surgeon's Glove With Non-pyrogenic statement

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 23, 2006 Received: February 24, 2006

Dear Ms. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becally of the device is substantially equivalent (for the referenced above and have determined the accessful marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to tray been reclassified in accordance with the provisions of Amendinents, or to devices that in the e Act (Act) that do not require approval of a premarket nic redelar Pood, Drug, and Cosmetic . . 00 (126) - 16) .
approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include confors provisions of the Fist." tion and 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 If your device is classified (000 about on trols. Existing major regulations affecting (FMA), It may of subject to Such additions, Title 21, Parts 800 to 898. In your device can oc found in the bous nouncements concerning your device in the Federal Register. ﺐ

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Page 2 - Ms. Kathleen 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 (OS) 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 continue 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/dsma/dsmamain.html

Sincerely yours,

Susan Rumm

Chia-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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## Indications for Use

510(k) Number (if known):

Device Name: Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement

Indications For Use:

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

Over-The-Counter Use __ AND/OR Prescription Use × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Shula M. Murphy D 5/2/06

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K053442