CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES

K042238 · Seal Polymer Industries Bhd. · LZA · Sep 16, 2004 · General Hospital

Device Facts

• Record ID: K042238
• Device Name: CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
• Applicant: Seal Polymer Industries Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 16, 2004
• 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 patient examination glove; polymer coated; powder-free. Worn by healthcare professionals on hands or fingers during medical examinations. Acts as a protective barrier to prevent cross-contamination between patient and examiner. Manufactured in various colors (blue, white, violet, pink, green). Performance verified against ASTM D6319-00aE3 standards for watertightness, dimensions, and physical properties (tensile strength, elongation). Biocompatibility confirmed via primary dermal irritation and guinea pig sensitization tests.

Clinical Evidence

Bench testing only. Performance data includes watertightness (1000 ml test), dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before and after aging) per ASTM D6319-00aE3. Powder content verified below 2mg/glove. Biocompatibility testing included primary dermal irritation and Guinea Pig Sensitization (Buehler) tests. All results met or exceeded ASTM and FDA requirements.

Technological Characteristics

Nitrile rubber material; polymer coated; powder-free. Dimensions: 240mm minimum length; 0.08mm minimum thickness (finger/palm). Physical properties: >14.0 MPa tensile strength (before/after aging); >500% elongation (before aging), >400% (after aging). Meets ASTM D6319-00aE3 and FDA pinhole/powder residual requirements. Biocompatible.

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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K042238/si

## SEP 1 6 2004

## SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

| 1.0 | | SMDA 510 (K) SUMMARY |
|-----|--------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES BERHAD<br>Lot 72706, Jalan Lahat<br>Kawasan Perindustrian Bukit Merah<br>31500 Lahat, Perak, Malaysia |
| | Tel | (60 5) 322 3200 |
| | Fax | (60 5) 322 2300 |
| | Name of Contact Person | Ms. CHUN CHOOI FONG |
| | Date of Summary Prepared | August 13, 2004 |
| 3.0 | Name of Device | |
| | Product Name | Cashmere Polymer Coated Powder Free Nitrile<br>Examination Gloves (Blue, White, Violet, Pink,<br>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.

### The Intended Use of Glove 6.0

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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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# SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 -- 322 2300

### Summary of Performance Data: 7.

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

| TEST | ASTM D6319-00aE3<br>AQL=2.5% | POLYMER COATED POWDER FREE NITRILE EXAM GLOVES<br>AQL=2.5% | |
|------------------------------------------------------------------|------------------------------|------------------------------------------------------------|--|
| 1. Watertight (1000 ml) | G I | Pass GI | |
| 2. Length (mm)<br>Size | Min 230 | 240 mm minimum for all sizes | |
| XS | Min 230 | | |
| S | Min 230 | | |
| M | Min 230 | | |
| L | Min 230 | | |
| XL | Min 230 | | |
| 3. Palm width (mm)<br>Size | - | <80 mm | |
| XS | 80 +/- 10 | 85 +/- 3 mm | |
| S | 95 +/- 10 | 95 +/- 3 mm | |
| M | 111 +/- 10 | 105 +/- 3 mm | |
| L | - | 111 +/- 3 mm | |
| XL | - | 120 +/- 3 mm | |
| XXL | | | |
| 4. Thickness (mm)<br>(Single Layer) | | | |
| Finger | Min 0.05 | 0.08 minimum | |
| Palm | Min 0.05 | 0.08 minimum | |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (Mpa) | Min 14.0 | 20.4* | |
| Ultimate Elongation (%) | Min 500 | 618* | |
| After Aging<br>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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## SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

- The performance data of the glove as showed above meet the ASTM D6319-00a" 8. Standard and FDA's requirement. Standard and I Dr. For ow 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 meet the below specifications:

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

Page 3 of 3 ATTACHMENT Q

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

SEP 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Chun Chooi Fong Quality Management System Manager Seal Polymer Industries Berhad Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, MALAYSIA

Re: K042238

Trade/Device Name: Cashmere 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: September 9, 2004 Received: September 13, 2004

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 mendments, 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 controls provision 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 may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device our re roublish 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 and if in the (s 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) rms receet 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), n you dontact 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph. D.

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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K042238/s1

## INDICATIONS FOR USE STATEMENT

: Seal Polymer Industries Berhad Applicant

510(K) Number :

: Cashmere 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 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 Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Morley

sthasi

510(k)

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