POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE

K070760 · Derma Care Plus Products, LLC · LYY · Jun 7, 2007 · General Hospital

Device Facts

• Record ID: K070760
• Device Name: POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
• Applicant: Derma Care Plus Products, LLC
• Product Code: LYY · General Hospital
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.

Device Story

Device is a non-sterile, powder-free, chlorinated latex patient examination glove. Incorporates colloidal oatmeal USP as a skin protectant. Features a protein content claim of 50 micrograms or less per gram of glove. Used in clinical or medical settings by healthcare examiners to provide a barrier against contamination between the examiner and the patient. Device is a physical barrier; no electronic or algorithmic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Chlorinated latex. Additive: Colloidal oatmeal USP (skin protectant). Form: Powder-free, non-sterile patient examination glove. Protein content: ≤ 50 micrograms/gram. No electronic components or software.

Indications for Use

Indicated for use as a non-sterile, powder-free latex examination glove for medical purposes to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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

Mr. Joseph H. Neuser President Derma Care Plus Products, LLC 1500 River Pines Drive Green Bay, Wisconsin 54311

JUN - 7 2007

Re: K070760

Trade/Device Name: Power Free Chlorinated Latex Patient Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with a Protein Claim of 50 Microgram or Less per Gram of Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 25, 2007 Received: May 30, 2007

Dear Mr. Neuser:

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.

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

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Page 2 - Mr. Neuser

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 vour 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 vours,

Chin 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 Statement: Include the following or equivalent Indications 3.0 for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

## INDICATIONS FOR USE STATEMENT

## Applicant: DERMA CARE PLUS PRODUCTS, LLC

510(k) Number (if known): N/A

Device Name: POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE

Indications For Use: A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.

Prescription Use: NO

and /or Over-The-Counter Use: YES

(21 CFR 801 Subpart C)

Shule A. Murphy, MD

sion of Anesthesiology, General Hospital, Control, Control, Dental Devicess

(K) Number: K070760

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