POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)

K050528 · Spi Gloves Sdn. Bhd. · LZA · May 19, 2005 · General Hospital

Device Facts

• Record ID: K050528
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
• Applicant: Spi Gloves Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: May 19, 2005
• 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 hands or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn on hands/fingers by healthcare personnel during medical examinations; acts as a physical barrier to prevent cross-contamination between patient and examiner. Device is non-sterile, powder-free, and available in multiple colors (Blue, White, Violet, Pink, Green, Black). Manufactured to meet ASTM D6319-00a standards for physical dimensions, tensile strength, and elongation. Used in clinical settings to protect both patient and provider.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000 ml), dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before and after aging) compared against ASTM D6319-00a standards. All results met or exceeded ASTM requirements.

Technological Characteristics

Nitrile rubber material; powder-free; single-layer construction. Dimensions: 240 mm minimum length; 0.08 mm minimum thickness (finger/palm). Physical properties: >21.8 MPa tensile strength (before aging), >620% elongation (before aging). Complies with ASTM D6319-00a and FDA water leak test (AQL 2.5%).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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

• Class 1 Nitrile Patient Examination Glove 80LZA

Submission Summary (Full Text)

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K-050528

# SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

MAY 1 9 2005

| 1.0 | <b>SMDA 510 (K) SUMMARY</b> | |
|-----|-----------------------------|----------------------------------------------------------------------------------------------------------------|
| 2.0 | Submitter | SPI GLOVES SDN. BHD.<br>5, Persiaran Greentown 8,<br>Greentown Business Centre,<br>30450 Ipoh, Perak, Malaysia |
| | Tel | (60 5) 322 3200 |
| | Fax | (60 5) 322 2300 |
| | Name of Contact Person | Ms. CHUN CHOOI FONG |
| | Date of Summary Prepared | February 24, 2005 |
| 3.0 | <b>Name of Device</b> | |
| | Device Name | Powder Free Nitrile Examination Glove |
| | Common Name | Exam Glove |

#### 4.0 Identification of the Legally Marketed Devices

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a43 and FDA requirements.

Nitrile Patient Examination Glove

### Description of The Device 5.0

Classification Name

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.

#### The Intended Use of Glove 6.0

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

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SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

## 7. Summary of Performance Data:

Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.

| TEST | ASTM D6319-00aE3 | POWDER FREE NITRILE EXAM GLOVES |
|----------------------------------------|------------------|---------------------------------|
| 1. Watertight (1000 ml) | G I<br>AQL=2.5% | Pass Gl<br>AQL=2.5% |
| 2. Length (mm)<br>Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)<br>Size XS | - | <80 mm |
| S | 80 +/- 10 | 85 +/- 3 mm |
| M | 95 +/- 10 | 95 +/- 3 mm |
| L | 111 +/- 10 | 105 +/- 3 mm |
| XL | - | 111 +/- 3 mm |
| XXL | - | 120 +/- 3mm |
| 4. Thickness (mm) (Single Layer) | | |
| Finger | Min 0.05 | 0.08 minimum |
| Palm | Min 0.05 | 0.08 minimum |
| 5. Physical Properties | | |
| Before Aging<br>Tensile Strength (Mpa) | Min 14.0 | *21.8 |
| Ultimate Elongation (%) | Min 500 | *620 |
| After Aging<br>Tensile Strength (Mpa) | Min 14.0 | *25.7 |
| Ultimate Elongation (%) | Min 400 | *584 |
| 6. Powder Content | | Below 2mg / glove |

* The average number obtained from Attachment C.

Page 2 of 3 ATTACHMENT P

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2005

Ms. Chooi Fong Chun Quality Management System Manager SPI Gloves Sdn. Bhd. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, MALAYSIA

Re: K050528

Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Green, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 5, 2005 Received: May 9, 2005

Dear Ms. Chun:

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 Ameridate connants, 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 approvisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 mr.), it hay ob adjoco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of a may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Ms. Chun

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled of a baseaux and other with other requirements mean that FDA nas made a determinations administered by other Federal agencies. of the Act of ally receital statutes and regurements, including, but not limited to: registration You must conting with an the Hood reg (21 CFR Part 801); good manufacturing practice and listing (21 CFK Pat 807), laboling (21 CFR Partialion (21 CFR Part 820); and if requirements as set form in the quality byotents (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailitaling of substantial equivalence of your device to a premarket notification. - The PDF Intelling or a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice to: Joiasce at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorinational and Consumer Assistance at its toll-free Division of 01 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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 STATEMENT

: SPI Gloves Sdn. Bhd. Applicant

KOZOZZ V 510(K) Number :

: Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Device Name Green, Black)

Indication For Use:

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

............................................................................................................................................................................ Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ........................................ Per 21 CFR 80.109

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()ver-The-Counter ....

Shiela M. Murphy KP

sion Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, DIVIsion Of Ancolnoental Devices

infection control.

510(k) Number: K950528