MULTIPLE NAME

K123760 · Assurguard Sdn. Bhd. · LZA · Jan 28, 2013 · General Hospital

Device Facts

• Record ID: K123760
• Device Name: MULTIPLE NAME
• Applicant: Assurguard Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 28, 2013
• 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, non-sterile, ambidextrous patient examination glove; manufactured from nitrile butadiene rubber; available in blue and white colors. Used by healthcare professionals in clinical settings to provide a protective barrier on the hands; prevents contamination between patient and examiner. Single-use device; supplied in dispenser boxes. Performance verified against ASTM D6319 standards for physical properties, dimensions, and freedom from pinholes.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property testing, freedom from pinholes, powder residue limits, and biocompatibility (dermal sensitization and primary skin irritation) per ASTM and ISO standards.

Technological Characteristics

Material: Nitrile butadiene rubber. Form factor: Ambidextrous, powder-free, blue or white. Standards: ASTM D6319 (dimensions, physical properties, pinholes, powder residue), ASTM D5151 (pinholes), ASTM D6124 (powder residue). Biocompatibility: ISO 10993-10 (dermal sensitization), 16 CFR Part 1500 (primary skin irritation). Non-sterile.

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

• Blue Powder Free Nitrile Patient Exam Glove (K121464)

Submission Summary (Full Text)

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K123760

## ASSURGUARD SDN. BHD. (Company No.888413-H)

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

### Date: 16 January 2013

#### 1.0 Submitter:

### JAN 2 8 2013

| Name: | ASSURGUARD SDN. BHD. |
|-------------------|------------------------------------------------------------------|
| Address: | 82F, Jalan Pulasan, 41000 Klang, Selangor Darul Ehsan, Malaysia. |
| Country: | Malaysia |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| Registration No.: | Pending (First Device) |

#### 2.0 Contact Person:

| Contact: | Mr. Lim Hui Guan |
|----------------|----------------------|
| E-mail: | [e-mail] |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of Device:

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

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

The Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-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: K121464, Blue Powder Free Nitrile Patient Exam Glove

#### 5.0 Description of Device:

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.

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### ASSURGUARD SDN. BHD. (Company No.888413-H)

#### 6.0 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: 7.0

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, possesses the following technological characteristic (as 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 5151-11<br>ASTM D 6319-10 | Meets<br>Meets |
| Powder Free Residue | ASTM D 6124-11<br>ASTM D 6319-10 | Meets<br>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 |

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

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

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

Clinical data are not needed for market cleared examination gloves.

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## ASSURGUARD SDN. BHD. (Company No.888413-H)

#### 10.0 Conclusion

It can be concluded that the Powder Free Nitrile Patient Examination Gloves, 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 7.0 above.

#### 11.0 Substantial Equivalence Discussion

There is no different between the proposed device and the predicate with respect to indications for use and technological characteristics.

The gloves are identical to predicate device with 510(k) K121464.

The substantial equivalence comparison is presented in Table below:-

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ASSURGUARD SDN. BHD. (Company No.888413-H

Section 11.0 Substantial Equivalence Compariso

| Characteristics | Predicate Device<br>K121464, Blue Powder Free Nitrile Patient Exam Glove | Proposed Device<br>Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Product Code | 80 LZA | Same |
| FDA Device Class | Class I | Same |
| Intended Use | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Same |
| 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. | Same |
| Construction | Ambidextrous, Powder Free, Blue, per ASTM D6319 specification. | Ambidextrous, Powder Free, Blue and White, per ASTM D6319 specification. |
| Materials | Nitrile Butadiene Rubber | Same |
| Performance<br>I. Sterility<br>II. Freedom from holes<br>III. Dimension | Non-Sterile<br>Meets ASTM D6319<br>Meets ASTM D6319 | Same<br>Same<br>Same |

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ASSURGUARD SDN. BHD. (Company No.888413-H

| V. | | |
|---------------------------|----------------------------------------------------------------------------|------|
| Physical<br>Properties | Meets ASTM D6319 | Same |
| V. Powder Free<br>Residue | Meets ASTM D6319 | Same |
| Single Use | Yes | Same |
| Biocompatibility Test | Passes<br>i. Primary Skin Irritation Test<br>ii. Dermal Sensitization Test | Same |
| Packaging | Packed in Dispenser Boxes | Same |

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### January 28, 2013

Mr. Lim Hui Guan Managing Director Assurguard Sdn. Bhd. 82F, Jalan Pulasan Selangor Darul Ehsan Malaysia 41000

Re: K123760

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: December 1, 2012 Received: December 7, 2012

Dear Mr. Guan:

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthong Lo mia

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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## Indications for Use

510(k) Number (if known): K \23 760

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

Indication 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

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)

# Elizabeth F. Claverie 2013.01.22 18:10:26 -05'00'

K/23760

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

510(k) Number:

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