MULTIPLE NAME

K103337 · Ideal Quality Sdn., Bhd. · LZA · Feb 25, 2011 · General Hospital

Device Facts

• Record ID: K103337
• Device Name: MULTIPLE NAME
• Applicant: Ideal Quality Sdn., Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 examination glove; worn by healthcare examiners to provide barrier protection; prevents cross-contamination between patient and examiner. Device is non-sterile; available in white or blue. Manufactured to meet ASTM D6319 standards for physical properties, dimensions, and freedom from pinholes. Used in clinical or medical settings; provides a physical barrier to reduce exposure to contaminants during patient examinations.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and adherence to ASTM standards (D6319, D5151, D6124, F720-81) and 16CFR Part 1500.

Technological Characteristics

Material: Nitrile. Standards: ASTM D6319 (dimensions, physical properties), ASTM D5151 (pinholes), ASTM D6124 (powder residue), ASTM F720-81 (dermal sensitization), 16CFR Part 1500 (skin irritation). Form factor: Disposable, non-sterile, powder-free glove. Available in white or blue.

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. Suitable for general patient examination settings.

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 Examination Glove, White (Non-Colored) and Blue Colored (K060771)

Submission Summary (Full Text)

{0}------------------------------------------------

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

### Date: 12 February 2011

#### 1.0 Submitter:

IDEAL QUALITY SDN. BHD. Lot 2796, 17 1/2 Miles, Jalan Kapar, 42200 Klang, Selangor Darul Ehsan, Malaysia.

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

#### 2.0 Contact Person:

| Contact: | Mr. SH TAN |
|----------------|-------------------------|
| E-mail: | [e-mail] |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of Device:

| Trade Name: | Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non-Sterile |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove. |

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

The Powder Free Nitrile Examination Gloves, White (non colored) or Blue (colored), Non-Sterile, Class I Patient Examination gloves, 80LZA, meets all of the requirements of ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate Device: K060771, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue Colored

#### 5.0 Description of Device:

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.

{1}------------------------------------------------

## IDEAL QUALITY SDN. BHD. (Company No.404964-P)

#### 6.0 Intended Use of the Device:

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

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.

#### 7.0 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.

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

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Dimensions | ASTM D 6319 – 00a<br>(2005) | Meets |
| Physical Properties | ASTM D 6319 – 00a<br>(2005) | Meets |
| Freedom from pin-holes | ASTM D 5151 – 99 (2006)<br>ASTM D 6319 – 00a<br>(2005) | Meets<br>Meets |
| Powder Free Residue | ASTM D 6124 – 06<br>ASTM D 6319 – 00a<br>(2005) | Meets<br>Meets |
| Biocompatibility | Dermal Sensitization<br>(as per ASTM F720-81)<br><br>Primary Skin Irritation Test<br>(as per 16CFR Part1500) | Not a contact skin sensitizer<br><br>Not a primary skin irritant |

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

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

> Lot 2796, 17 ½ Mile, Jalan Kapar, 42200 Klang, Selangor, Malaysia Tel: [phone], Fax: [phone]

{2}------------------------------------------------

# IDEAL QUALITY SDN. BHD. (Company No.404964-P)

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

Clinical data are not needed for market cleared examination gloves.

#### 11.0 Conclusion

It can be concluded that the Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored) or, Non Sterile is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 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.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

#### Public Health Service

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

Mr. SH TAN Quality Assurance Manager IDEAL QUALITY SDN. BHD. Lot 2796, 17 1/2 Miles Jalan Kapar, 42200 Klang, Selangor Darul Ehsan. Malaysia

FEB 2 5 231

Re: K103337

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: February 12, 2011 Received: February 16, 2011

Dear Mr. TAN:

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 Eederal Register.

{4}------------------------------------------------

### Page 2- Mr. TAN

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Bauer

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

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

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

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

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

x Over-The-Counter Use (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)

Eby, Wit H. Clavine-Will

ision of Anesthesiology, General Hospit ision Control, Dentrol, Devices i

510(k) Number