POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR

K050526 · Spi Gloves Sdn. Bhd. · LYY · Dec 6, 2005 · General Hospital

Device Facts

• Record ID: K050526
• Device Name: POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
• Applicant: Spi Gloves Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications 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.

Device Story

Polymer-coated, online-chlorinated, powder-free latex examination glove; disposable; worn by healthcare examiners. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Manufactured from natural rubber latex; processed with polymer coating and online chlorination to achieve powder-free status and low protein content. Used in clinical settings; provides protection during patient examinations. Benefits include reduced risk of contamination and minimized potential for latex protein sensitization due to low protein levels.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000 ml, AQL 2.5%), physical dimensions, tensile strength (before/after aging), ultimate elongation, powder content (<2mg/glove), and protein content (<50 micrograms/gram). Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests.

Technological Characteristics

Natural rubber latex; polymer coated; online chlorinated. Powder-free (<2mg/glove). Protein content <50 micrograms/gram. Dimensions: 240mm minimum length; thickness 0.10mm minimum. Meets ASTM D3578-01a standards. Non-sterile.

Indications for Use

Indicated for use as a disposable medical device 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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### DEC 6 2005

K050526

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 11, 2005 |
| 3.0 | Name of Device | |
| | Device Name | Polymer Coated Online Chlorinated Powder Free<br>Latex Examination Gloves |
| | Common Name | Exam Glove |
| | Classification Name | Latex Patient Examination Glove |

#### Identification of the Legally Marketed Devices 4.0

Class 1 Latex Pationt Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a22 and FDA requirements.

#### 5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" 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 O

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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 D3578-01a" and FDA 1000 ml watertight test.

| TEST | ASTM D3578-01aE2 | | POLYMER COATED ONLINE CHLORINATED POWDER FREE LATEX EXAM GLOVES | |
|--------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------|-----------------------------------------------------------------|------------------------------|
| 1. Watertight (1000 ml) | GI | AQL=2.5% | Pass GI | AQL=2.5% |
| 2. Length (mm)<br>Size XS<br>S<br>M<br>L<br>XL | | Min 230<br>Min 230<br>Min 230<br>Min 230<br>Min 230 | 240 mm minimum for<br>all sizes | |
| 3. Palm width (mm)<br>Size XS<br>S<br>M<br>L<br>XL | | -<br>80 +/- 10<br>95 +/- 10<br>111 +/- 10<br>- | <80 mm<br>85 +/- 3 mm<br>95 +/- 3 mm<br>105 +/- 3 mm<br>>110 mm | |
| 4. Thickness (mm)<br>(Single Layer)<br><br>Finger<br>Palm | | Min 0.08<br>Min 0.08 | | 0.10 minimum<br>0.10 minimum |
| 5. Physical Properties<br><br><b>Before Aging</b><br>Tensile Strength (Mpa)<br>Ultimate Elongation (%) | Min 14.0<br>Min 650 | | *23.9<br>*812 | |
| <b>After Aging</b><br>Tensile Strength (Mpa)<br>Ultimate Elongation (%) | Min 14.0<br>Min 500 | | *19.3<br>*741 | |
| 6. Powder Content | - | | Below 2mg / glove | |
| 7. Protein Content | - | | Below 50 microgram / gram | |

* The average result obtained from Attachment C.

Page 2 of 3 ATTACHMENT O

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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 D3578-01a" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
- 9. 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 Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves meet the below specifications:

- ASTM D3578-01a'-- Standard -
- -FDA pinhole requirements
- -FDA minimum powder residual content

Page 3 of 3 ATTACHMENT O

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.

DEC & 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050526

Trade/Device Name: Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 24, 2005 Received: November 28, 2005

### Dear Ms. 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. 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 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/cdrh/industry/support/index.html.

Sincercly yours,

Snette y. Michael Ons.

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

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# INDICATIONS FOR USE STATEMENT

Applicant : SPI Gloves Sdn. Bhd.

510(K) Number :

- Device Name : Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 micrograms or less of Total Water Extractable Protein per Gram)
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.

### . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODC)

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

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Over-The-Counter ..... X ..........

Shida A. Humphrey, MD 12/6/05

A050526

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