POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)

K050531 · Spi Gloves Sdn. Bhd. · LZA · Mar 18, 2005 · General Hospital

Device Facts

• Record ID: K050531
• Device Name: POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)
• Applicant: Spi Gloves Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 18, 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 powdered nitrile examination glove; worn on examiner's hands or fingers; acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Device performance verified via watertight testing (1000 ml), physical property testing (tensile strength, elongation), and biocompatibility testing (dermal irritation, sensitization).

Clinical Evidence

Bench testing only. Performance data includes watertight (1000 ml) testing, physical property testing (tensile strength, ultimate elongation before/after aging), and powder content analysis. Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests. All results met ASTM D6319-00a53 and FDA requirements.

Technological Characteristics

Material: Nitrile rubber; powdered with absorbable dusting powder. Dimensions: 240 mm minimum length; various palm widths. Thickness: 0.08 mm minimum. Standards: ASTM D6319-00a53. Biocompatibility: Passed Primary Dermal Irritation and Guinea Pig Sensitization tests.

Indications for Use

Indicated for use as a disposable medical glove worn on the hands or fingers by healthcare examiners 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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# MAR 1 8 2005

## 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 25, 2005 |
| 3.0 | Name of Device | |
| | Device Name | Powdered Nitrile Examination Glove |
| | Common Name | Exam Glove |
| | Classification Name | Nitrile Patient Examination Glove |

#### 4.0 Identification of the Legally Marketed Devices

Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

#### Description of The Device 5.0

Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which 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.

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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.

| TEST | ASTM D3578-01aE2<br>AQL=2.5% | POWDERED NITRILE EXAM<br>GLOVES<br>AQL=2.5% |
|--------------------------------------------|------------------------------|---------------------------------------------|
| 1. Watertight (1000 ml) | G I | Pass GI |
| 2. Length (mm)<br>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)<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+/-3 mm |
| 4. Thickness (mm)<br>(Single Layer) | | |
| Finger | Min 0.08 | 0.08 minimum |
| Palm | Min 0.08 | 0.08 minimum |
| 5. Physical Properties<br><br>Before Aging | | |
| Tensile Strength (Mpa) | Min 14.0 | 30.4 |
| Ultimate Elongation (%) | Min 650 | 640 |
| After Aging | | |
| Tensile Strength (Mpa) | Min 14.0 | 30.9 |
| Ultimate Elongation (%) | Min 500 | 610 |
| 6. Powder Content | - | Below 10 mg / dm2 |

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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]

- The performance data of the glove as showed above meet the ASTM D6319-00a53 8. Standard and FDA's requirement. Powder content is below 10 mg per dm2, which meet the FDA Requirements.
- ਹੇ. The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
- 10. Conclusion

We concluded that the Powdered Nitrile Examination Gloves meet the below specifications:

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

Page 3 of 3 ATTACHMENT N

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

MAR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050531

Trade/Device Name: Powdered Nitrile Examination Gloves (Blue, White) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 28, 2005 Received: March 2, 2005

Dear. Ms. Chooi 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.

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 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. Chooi 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mav 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/cdrh/industry/support/index.html.

Sincerely yours.

Sophie Michie and

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 : K050531

Device Name : Powdered Nitrile Examination Gloves (Blue, White)

Indication For 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.

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

AND/OR

Over-The-Counter ....................... (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)

Shade H. Murphy, R 2/1/05

nesthesiology, General Hospital, trol Dental Devic

Number: K050531
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