POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE

K111772 · Kossan Latex Industries(M)Sdn Bhd · LZA · Oct 20, 2011 · General Hospital

Device Facts

• Record ID: K111772
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
• Applicant: Kossan Latex Industries(M)Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove 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 patient examination glove; non-sterile; blue or white. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Manufactured from nitrile rubber. Used in clinical settings. Provides protection via physical barrier properties. Benefits include reduced risk of cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including dimensions, physical properties (ASTM D6319-10), freedom from pinholes (ASTM D5151-06), powder-free residue (ASTM D6124-06), and biocompatibility (ISO 10993-10, 16 CFR 1500).

Technological Characteristics

Nitrile rubber examination glove. Meets ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (pinholes), and ASTM D6124-06 (powder residue). Biocompatibility per ISO 10993-10. Non-sterile. Blue or white color.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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

• Powder Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Non-Sterile (K062764)

Submission Summary (Full Text)

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# KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

0CT 2 0 2011

대한민국 대학

# FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information

## 1.0 Submitter:

Kossan Latex Industries (M) Sdn Bhd Lot 6129, Jalan Haji Abdul Manan, Batu 5 %, Jalan Meru, Klang, 41050 Selangor, Malaysia

| Telephone No.: | [phone] |
|----------------|----------------|
| Fax No.: | [phone] |

## 2.0 Contact Person:

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

| Contact: | Ms S F Cho |
|----------------|----------------|
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Preparation Date: 30 September 2011

## 4.0 Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non- Colored). Non-Sterile. Common Name: Powder-Free Nitrile Patient Examination Glove Classification Name: Patient Examination Glove (21 CFR Part 880.6250)

## 5.0 Identification of the Legally Marketed Device:

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile; Class I Patient Examination Gloves, Nitrile-80LZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate Device: K062764, Powder Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Non-Sterile. Tested For Use with Chemotherapy Drugs

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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

## Description of Device: 6.0

.

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, meets all of the requirements of ASTM D 6319-10.

### 7.0 Intended Use of the Device:

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

## Summary of the Technological Characteristics of the Device: 8.0

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Non-Sterile, possesses the following technological characteristic (as Colored). compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|----------------------------|-----------------------------------------------------------------|-------------------------------|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-<br>holes | ASTM D 5151-06 | Meets |
| | ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| | ASTM D 6319-10 | Meets |
| | | |
| Biocompatibility | Dermal Sensitization<br>(as per ISO 10993-<br>10:2010) | Not a contact skin sensitizer |
| | Primary Skin<br>Irritation Test<br>(as per 16 CFR Part<br>1500) | Not a primary skin irritant |

## Substantial Equivalent Based on Assessment of Non-Clinical Performance 9.0 Data

The performance test data that support a determination of substantial equivalence are described above.

## Substantial Equivalent Based on Assessment of Clinical Performance Data 10.0

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K1

## 11.0 Conclusion

lt can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, is safe and effective for use and will perform according to the glove performance standards referenced in Section 8.0 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.

Consequently, this device is substantially equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 2 0 2011

Ms. Cho Sow Fong RA Manager Kossan Latex Industries (M) SDN BHD Lot 6129, Jalan Haii Abdul Manan, Batu 5 ¼, Jalan Meru, Klang, 41050 Selangor, Malaysia

Re: K111772

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored and

White (Non-Colored). Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 30, 2011 Received: October 5, 2011

Dear Ms. Fong:

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 - Ms. Fong

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Minton

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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# Inuncations 101 USC

# 1777

# 510(k) Number (if known):

| Device Name: | Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile. |
|--------------|----------------------------------------------------------------------------------------------------|
|--------------|----------------------------------------------------------------------------------------------------|

# Indications for Use:

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

x Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Elijabeth S. Clamur WMS
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111772

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