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

K050530 · Spi Gloves Sdn. Bhd. · LZA · Mar 16, 2005 · General Hospital

Device Facts

• Record ID: K050530
• Device Name: POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)
• Applicant: Spi Gloves Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 16, 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; acts as physical barrier to prevent cross-contamination between patient and examiner. Device is non-sterile, powder-free, and polymer-coated. Used in clinical settings. Provides protection during patient examinations.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000 ml), physical dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before/after aging) per ASTM D6319-00aE3. Biocompatibility testing includes Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests. All tests met ASTM and FDA requirements.

Technological Characteristics

Nitrile rubber material; powder-free; polymer-coated. Dimensions and physical properties conform to ASTM D6319-00aE3. Thickness: 0.08 mm minimum. Tensile strength: >14.0 MPa (before aging). Ultimate elongation: >500% (before aging). Residual powder content: <2 mg/glove. Non-sterile.

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.

Submission Summary (Full Text)

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K050530

### MAR 1 6 2305 SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

| 1.0 | | SMDA 510 (K) SUMMARY |
|-----|--------------------------|----------------------------------------------------------------------------------------------------------------|
| 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 23, 2005 |
| 3.0 | Name of Device | |
| | Device Name | Polymer Coated Powder Free Nitrile Examination<br>Gloves (Blue, White, Violet, Pink, Green) |
| | Common Name | Exam Glove |
| | Classification Name | Nitrile Patient Examination Glove |

#### Identification of the Legally Marketed Devices 4.0

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

#### 5.0 Description of The Device

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

#### 6.0 The Intended Use of Glove

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.

> Page 1 of 3 ATTACHMENT Q

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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]

### Summary of Performance Data: 7.

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

| | | POLYMER COATED POWDER<br>FREE NITRILE EXAM GLOVES | |
|-------------------------------------|------------------|---------------------------------------------------|----------|
| TEST | ASTM D6319-00aE3 | Pass GI | AQL=2.5% |
| 1. Watertight (1000 ml) | GI<br>AQL=2.5% | | |
| 2. Length (mm) | | | |
| Size XS | Min 230 | 240 mm minimum for<br>all sizes | |
| S | Min 230 | | |
| M | Min 230 | | |
| L | Min 230 | | |
| XL | Min 230 | | |
| 3. Palm width (mm) | | | |
| 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 +/- 3 mm | |
| 4. Thickness (mm)<br>(Single Layer) | | | |
| Finger | Min 0.05 | 0.08 minimum | |
| Palm | Min 0.05 | 0.08 minimum | |
| 5. Physical Properties | | | |
| Before Aging | | | |
| Tensile Strength (Mpa) | Min 14.0 | 20.4* | |
| Ultimate Elongation (%) | Min 500 | 618* | |
| After Aging | | | |
| Tensile Strength (Mpa) | Min 14.0 | 21.3* | |
| Ultimate Elongation (%) | Min 400 | 616* | |
| 6. Powder Content | - | Below 2mg / glove | |

* indicates the average results from Attachment C. .

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K050530

## SPI GLOVES SDN. BHD.

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

- The performance data of the glove as showed above meet the ASTM D6319-00a53 છે. Standard and FDA's requirement. Standard and I'DA's requirement.
Powder content is below 2mg per glove, which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
- Conclusion 10.

We concluded that the Polymer Coated Powder Free Nitrile Examination Gloves mect the below specifications:

- ASTM D6319-00a53 Standard -
- FDA pinhole requirements -
- FDA minimum powder residual content --

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

MAR 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050530

KU5030
Trade/Device Name: Polymer Coated Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 28, 2005 Reccived: March 2, 2005

Dear Ms. Chooi Fong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaled by the device is substantially equivalent (for the referenced above and have determined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate continetee proof to that have been reclassified in accordance with the provisions of Allientificals, of to devices that tic Act (Act) that do not require approval of a premarket the reachar I vou, Drag, und Connects , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ricaration, 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 If your device is classified (500 above) in the subject to thisting major regulations afficeing (PMA), It may be subject to Sach adaxi Regulations. Title 21. Parts 800 to 898. In your device can be found in firsther announcements concerning your device in the Federal Register.

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## Page 2 -- Ms. Chooi Fong

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's Issuance of a stustinates with other requirements
mean that FDA has made a determination that your devices with other Federal agencies. mean that FDA has made a delemination that your and your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registra of the Act or any bederal statues and reginations and hot limited to: registration
You must comply with all the Act step of and annufacturing practice You must comply with all the Act 3 requirements, interest 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820); and i and listing (2) CFR Part 807); labeling (21 CFR Parts); Beach (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Parl 820); an requirements as set forth in the quality Systems (QS) regalation (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the success of the same and starticle spiralence of your device t This letter will anow you to begin matically your and equivalence of your device to a
premarket notification. The FDA finding of substantial from your dowee and thus, per premarket notification. The FDA miding of substantial equively of 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 Patt 801), If you desire specific advice for your device of [phone]. Also, please note the regulation prease contact the Office or Comphanes and premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain offer general mironmation on your and Consumer Assistance at its toll-free Division of Small 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

: SPI Gloves Sdn. Bhd. Applicant

510(K) Number : K 050530

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

Indication For Use:

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

Prescription Use: ....................................... (Part 21 CFR 801 Subpart D)

Over-The-Counter ....................... AND/OR (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)

Shule A. Murphy, MD

General Hospital

Dental Devices

A-05030

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