Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)

K142805 · Hartalega Sdb. Bhd. · LZA · Dec 18, 2014 · General Hospital

Device Facts

• Record ID: K142805
• Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
• Applicant: Hartalega Sdb. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) 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.

Device Story

Disposable nitrile examination glove; coated with colloidal oatmeal USP skin protectant; worn on examiner's hand or finger; functions as physical barrier to prevent cross-contamination between patient and examiner; used in clinical settings; provides protection during patient examinations.

Clinical Evidence

No clinical data provided; device relies on established material properties and intended use for patient examination gloves.

Technological Characteristics

Nitrile rubber material; powder-free; coated with colloidal oatmeal USP skin protectant; dark violet blue color; disposable; non-sterile; physical barrier design.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and 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.

Submission Summary (Full Text)

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

December 18, 2014

Hartalega Sdb. Bhd. % Nurul Aisyah Kong Quality Assurance Senior Manager No. 7 Kawasan Perusahaan Suria Bestari Jaya, 45600 Selangor Darul Ehsan MALAYSIA

- Re: K142805
Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LZA Dated: November 25, 2014 Received: November 28, 2014

Dear Ms. Aisyah 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, 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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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 devicerelated 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

**Tejashri Purohit-Sheth, M.D.**

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

### 510(k) Number (if known) K142805

#### Device Name

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)

#### Indications for Use (Describe)

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) 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.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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