NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING

K070639 · Siam Sempermed Corp., Ltd. · LZA · Jun 15, 2007 · General Hospital

Device Facts

• Record ID: K070639
• Device Name: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 15, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Non-sterile, powder-free nitrile examination glove; blue color; polymer-coated. Worn by healthcare examiners to provide a protective barrier against contamination between patient and examiner. Device is a single-use, disposable physical barrier.

Clinical Evidence

Bench testing only. Device meets ASTM D6319-00-ae3 for dimensions, physical properties, and freedom from pinholes. Powder residue meets ASTM D6124-2006 (≤2 mg/glove). Biocompatibility testing (primary skin irritation and guinea pig sensitization) passed.

Technological Characteristics

Nitrile material; powder-free; polymer-coated. Complies with ASTM D6319-00-ae3 (dimensions, physical properties, pinholes) and ASTM D6124-2006 (powder residue). Non-sterile. Class I device.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

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.

Predicate Devices

• Siam Sempermed Nitrile Examination Glove (K060753)

Submission Summary (Full Text)

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K07-0639

510 (k) Sumr

As Required by 21 section 807.92 (c)

- 1. Submitter Name: Siam Sempermed Corp., Ltd
- 110 Kanjanavanit Road. Pathong Hatyai 2. Address: Songkhla.Thailand 90230

JUN 5 2007

- ([phone]. Phone:
- ([phone]. Fax:
- 5. Contract Person: Mrs. Sureerat Choosri (Product Manager)
- Date summary prepared: February 15, 2007 6.
- 7. Official Correspondent: Sempermed USA Inc.
- 13900 49th Street North Address: 8. Clearwater, USA , FL 33762
- 9. Phone: [phone]
- 727 787 7558 10. Fax:
- 11. Contact person: Mr. William E. Harris

12. Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating

- 13. Device Common or usual name: Examination glove
14. Device Classification Name: Nitrile Patient Examination Glove (Powder free, Blue color)

#### 15. Description of the Device:

Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating

#### 16. Intended use of the device:

This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

### 17. Summary of The Technological Characteristics of The devices:

Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coated are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------|------------------------------------|--------------------|
| Dimensions | ASTM D 6319-00-ae³ | Meets |
| Physical Properties | ASTM D 6319-00-ae³ | Meets |
| Freedom from pinholes | ASTM D 6319-00-ae³ | Meets |
| Powder Free Residue | ASTM D 6124-2006 | ≤2 mg/glove |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passed |
| | Guinea Pig Sensitization | Passed |

#### 18. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

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#### 19. Conclusion

It can be concluded that the Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer if can of concluded that the Nortelen, rower standards referenced in section 17 above and meet ASTM coaliaged and FDA requirements. Consequently, this device is substantially equivalent to currently marketed Standados, and I 1971 roquention Concequents predicate device Siam Sempermed Nitrile, Examination Glove, devices. This donee is sale as s equivalent. This is better expressed in the tabulated comparison as below.

Technical comparison of specific elements is attached in the main submission.

| FDA file reference number | 510k number: K060753 |
|-----------------------------------------------------|------------------------------------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO APPENDIX 1 |
| | Comparison result |
| TECHNOLOGICAL<br>CHARACTERISTICS | REFER TO ADDITIONAL TECHNICAL<br>COMPARATIVE TABLE WITHIN 510K<br>SUBMISSION |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Not applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Not applicable |
| Compatibility with environment and<br>other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Not applicable |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President & CEO Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762

JUN 1 5 2007

Re: K070639

Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 30, 2007 Received: May 31, 2007

Dear Mr. Harris:

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. Harris

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.

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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# Indications for Use

长070639 510(k) Number (if known):

Non-sterile, Powder-Free Nitrile Examination Glove, Blue with Device Name: Polymer Coating Indications For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination betweeen patient and examiner.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

X Over-The-Counter Use (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)

Gesika Taylor - for Sheila Murphy

ision Sign-Off) Livision of Anesthesiology, General Ho Imaction Control, Dental

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510(k) Number: k070639

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