LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT

K123368 · Hartalega Sdn Bhd · LYY · May 7, 2013 · General Hospital

Device Facts

• Record ID: K123368
• Device Name: LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
• Applicant: Hartalega Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: May 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Latex Powder Free Examination Glove with Colloidal USP Skin Protectant is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Latex powder-free examination glove coated with colloidal oatmeal USP skin protectant; intended for use by healthcare examiners to prevent cross-contamination between patient and examiner. Device is non-sterile and disposable. Provides a physical barrier during medical examinations. Benefits include protection against contamination while potentially providing skin protection via the colloidal oatmeal additive.

Clinical Evidence

Bench testing only.

Technological Characteristics

Latex material; powder-free; coated with colloidal oatmeal USP skin protectant; non-sterile; disposable; patient examination glove.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn by healthcare examiners to prevent cross-contamination between the patient and the examiner.

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.

Predicate Devices

• Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant (K110656)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 07,2013

Ms. Nurul Aisyah Kong Quality Assurance Senior Manager Hartalega Sdn. Bhd. No. 7 Kawasan Perusahaan Suria 45600 Bestari Jaya Selangor, Malaysia

Re: K123368

Trade/Device Name: Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 13, 2013

Received: March 25, 2013

Dear Ms. Kong:

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. Ilsting 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 - Ms. Kong

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours,

for

Thith
urohits.

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

510(k) Number (if known): K123368

Device Name:

Latex Powder Free Examination Gloves with Colloidal Catmeal USP Skin Protectant.

Indications for Use:

The Latex Powder Free Examination Glove with Colloidal USP Skin Protectant is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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 OF NEEDED)

������������������������������������������������ Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Elizabeth F. Claverie Elizabeth DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130005586 Claverie 4, cn=Elizabeth F. Claverie Date: 2013:05.06 17:07:18 -04'00" (Division Sign-Off) Page __ of (Division Sign-On) Intection Control, Dental Devices K123368 510(k) Number:

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