POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE

K103734 · Central Medicare Sdn Bhd · LZA · Aug 19, 2011 · General Hospital

Device Facts

• Record ID: K103734
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
• Applicant: Central Medicare Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Nitrile Examination Glove, White Colored is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; made from butadiene acrylonitrile copolymer; worn on examiner's hand; serves as physical barrier to prevent cross-contamination between patient and examiner; used in clinical settings; provides protection during medical examinations.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is based on non-clinical bench testing, including physical property, dimension, pinhole, and biocompatibility (skin irritation and sensitization) testing per ASTM and FDA standards.

Technological Characteristics

Material: Nitrile compound (butadiene acrylonitrile copolymer). Form factor: Disposable examination glove, powder-free. Standards: ASTM D6319-00a (dimensions, physical properties), ASTM D412-98 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residue). Biocompatibility: ISO 10993-10:2007(E) (dermal sensitization), 16 CFR 1500:41 & 1500:3(c)(4) (skin irritation).

Indications for Use

Indicated for use as a disposable, synthetic, powder-free glove worn on the hand by medical 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.

Predicate Devices

• Blue Nitrile Examination Gloves, Powder Free (K093696)

Submission Summary (Full Text)

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K.103734

AUG 1 9 2011

## 510 (k) Summary

# POWDER FREE NITRILE EXAMINATION GLOVE WHITE COLORED

| 1.0 | Submitter's Name | : | Central Medicare Sdn. Bhd. |
|-----|---------------------|---|--------------------------------------------------------------------------------------------------------|
| 2.0 | Submitter's Address | : | PT 2609-2620 Bt 8, Jalan Changkat Jong<br>Mukim Changkat Jong<br>36000 Teluk Intan, Perak<br>Malaysia. |
| 3.0 | Telephone No. | : | 605-6231220 |
| 4.0 | Fax No. | : | 605-6231230 |
| 5.0 | Contact Person | : | Mr. K. F Cheong |
| 6.0 | Date of Preparation | : | 9th Feb 2011 |
| 7.0 | Name of Device | : | Powder Free Nitrile Examination Glove White Colored |

| Size | Model Number |
|-------------|--------------|
| Extra Small | WPF-35XS |
| Small | WPF-35S |
| Medium | WPF-35M |
| Large | WPF-35L |
| Extra Large | WPF-35XL |

Proprietary/Trade Name :

Common Name

Product Code

Powder Free Nitrile Examination Glove

Other clients private labeling .

Nitrile Examination Glove .

Classification Name : Patient Examination Glove

LZA

Device Classification I . .

Regulation Number 21 CFR 880.6250 .

.

#### 8.0 Identification of The Legally Marketed Device:

The Powder Free Nitrile Examination Glove, White Colored Class 1 patient examination gloves, Nitrile-80 LZA, meets all of the requirements of ASTM, D 6319-00a (Reapproved 2005) Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate device: Blue Nitrile Examination Gloves, Powder Free (K093696)

#### 9.0 Description of Device:

The Powder Free Nitrile Examination Glove White Colored Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-00a (Reapproved 2005)

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#### 10.0 Intended Use of the Device:

The Powder Free Nitrile Examination Glove, White Colored is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

#### 11.0 Summary of The Technological Characteristics of New Device Compared to The Predicate Device:

There is no different technology characteristic. Gloves are made from nitrile compound (dispersion of butadiene acrylonitrile copolymer) and the initial products are powder free nitrile examination gloves. The Powder Free Nitrile Examination Glove, White Colored possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Dimensions | ASTM D 6319-00a (Reapproved 2005) | Meets |
| Physical Properties | ASTM D 412-98 (Reapproved 2002) | Meets |
| Freedom From pin-holes | ASTM D 5151-06 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Dermal Sensitization in the guinea pig<br>(as per ISO 10993-10:2007(E) | Passes<br>Not a Dermal Sensitization |
| | Primary Skin Irritation Test in rabbits<br>(as per Consumer Product Safety<br>Commission, Title 16, Chapter II, Part<br>1500:41 & 1500:3(c)(4)): | Passes<br>Not a Primary Skin irritant |

#### 12.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

Testing performed per ASTM D 6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-00a.

Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.

#### 13.0 Brief description of Clinical Tests

No new clinical tests were conducted under this 510(k).

14.0 Conclusions Drawn from the Non-Clinical and Clinical Tests.

> It can be concluded that the Powder Free Nitrile Examination Glove, White Colored meet the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL, meet labeling claims. It is as safe as effective, and performed as well the legally marketed indentified in clause 8.0.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

Central Medicare SDN BHD C/O Mr. Nick Wang Encompass Medical Supplies 1930 Brea Canyon Road # 240, Diamond Bar Diamond Bar, California 91765

AUG 1 9 2011

Re: K103734

Trade/Device Name: Powder Free Nitrile Examination Gloves White Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 12, 2011 Received: August 15, 2011

Dear Mr. Wang:

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. Wang

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.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/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-firee number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jh for

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

:

### Applicant :

# Central Medicare Sdn. Bhd.

K 103734

510(k) Number (if known):

Device Name :

Powder Free Nitrile Examination Gloves White Colored.

| Size | Model Number |
|-------------|--------------|
| Extra Small | WPF-35XS |
| Small | WPF-35S |
| Medium | WPF-35M |
| Large | WPF-35L |
| Extra Large | WPF-35XL |

### Indication For Use :

A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

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

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

Concurrent of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510(k) Number: | K103734 |
|----------------|---------|
|----------------|---------|

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