POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG

K111589 · Derma Care Plus Products, LLC · LZA · Aug 23, 2011 · General Hospital

Device Facts

• Record ID: K111589
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
• Applicant: Derma Care Plus Products, LLC
• Product Code: LZA · General Hospital
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A single use, disposable, powder-free examination 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 white, chlorinated, powder-free nitrile patient examination glove containing colloidal oatmeal USP as a skin protectant. Used in clinical settings by healthcare providers to prevent cross-contamination between patient and examiner. Device is single-use and disposable; ambidextrous design. Provides a physical barrier during medical examinations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and compliance with ASTM D 6319-10 standards for nitrile examination gloves.

Technological Characteristics

Material: Nitrile; chlorinated. Form: Powder-free, ambidextrous, white. Standards: Meets ASTM D 6319-10. Additive: Colloidal oatmeal USP (skin protectant).

Indications for Use

Indicated for use as a single-use, disposable, powder-free patient examination glove worn by medical personnel 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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Joseph H. Neuser President Derma Care Plus Products, LLC 2614 Main Street Green Bay, Wisconsin 54311

AUG 2 3 2011

Re: K111589

Trade/Device Name: Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 3, 2011 Received: August 8, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devi Office of Device Evaluation Center of Devices and Radiological Health

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## INDICATIONS FOR USE STATEMENT

## Applicant: DERMA CARE PLUS PRODUCTS, LLC

Device Name: Powder free Nitrile patient examination glove with colloidal oatmeal USP a skin protectant drug

Classification Name: Glove, Patient Examination, Poly - 80 LZA

Device Description: White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.

Indications For Use: A single use, disposable, powder-free examination 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)

Eldrett F. Clemens-Williams
(Division Sign Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KI|1589