CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)

K032077 · Seal Polymer Industries Bhd. · LZA · Aug 19, 2003 · General Hospital

Device Facts

• Record ID: K032077
• Device Name: CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
• Applicant: Seal Polymer Industries Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 19, 2003
• 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; non-sterile; powder-free. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Manufactured from nitrile material. Tested for watertight integrity (1000 ml test), physical dimensions, and tensile strength/elongation before and after aging. Meets ASTM D6319-00a53 standards. Used in clinical settings.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (AQL 2.5%), dimensions, thickness (min 0.08mm), and physical properties (tensile strength and elongation) compared against ASTM D6319-00a53 requirements. Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests, which the device passed.

Technological Characteristics

Nitrile material; powder-free; non-sterile. Dimensions: 240mm minimum length; 0.08mm minimum thickness. Physical properties: >14.0 MPa tensile strength, >500% elongation (before aging). Complies with ASTM D6319-00a53 and FDA 1000 ml watertight test. Biocompatible per dermal irritation and sensitization testing.

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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K032077

# AUG 1 9 2003

### SEAL POLYMER INDUSTRIES SDN. BHD.

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 SDN BHD<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 | July 01, 2003 |
| 3.0 | Name of Device | |
| | Trade Name | Cashmere Non-Sterile, Powder Free Nitrile<br>Examination Gloves (Violet) |
| | Common Name | Exam Glove |
| | Classification Name | Nitrile Patient Examination Glove |

#### 4.0 ldentification of the Legally Marketed Devices

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.

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## SEAL POLYMER INDUSTRIES SDN. BHD.

Lot 72706, Jalan Lahat 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 D6319-00a3 | CASHMERE POWDER FREE NITRILE EXAM GLOVES | |
|----------------------------------------|-----------------|------------------------------------------|----------|
| 1. Watertight (1000 ml) | G I<br>AQL=2.5% | Pass GI | 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 | |
| S | 80 +/- 10 | 82 - 88 | |
| M | 95 +/- 10 | 92 - 98 | |
| L | 111 +/- 10 | 102 - 108 | |
| XL | - | >110 | |
| 4. Thickness (mm)<br>(Single Layer) | | | |
| Finger | Min 0.08 | 0.08 minimum | |
| Palm | Min 0.08 | 0.08 minimum | |
| 5. Physical Properties | | | |
| Before Aging<br>Tensile Strength (Mpa) | Min 14.0 | 23.9* | |
| Ultimate Elongation (%) | Min 500 | 760* | |
| After Aging<br>Tensile Strength (Mpa) | Min 14.0 | 24.3* | |
| Ultimate Elongation (%) | Min 400 | 640* | |
| 6. Powder Content | - | Below 2mg / glove | |

* indicates the average results from Attachment B2.

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### SEAL POLYMER INDUSTRIES SDN. BHD. 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. 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.
- 10. Conclusion

We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves meet:

- 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 & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2003

Mr. Chun Chooi Fong Quality Assurance Department Manager Seal Polymer Industries SDN. BHD. Lot 72706, Jalan, Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia

Re: K032077

Trade/Device Name: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 1, 2003 Received: July 7, 2003

Dear Mr. 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 - Mr. 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 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/dsmamain.html

Sincerely wours,

the proving Sharr Susan Runner, DDS, MA Interim 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

Applicant : Seal Polymer Industries Sdn. Bhd.

| 510(K) Number : | K032077 |
|-----------------|---------|
|-----------------|---------|

Device Name : Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet)

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.

Qim S. him

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number: K032027

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

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

OR

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