NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE

K081911 · Siam Sempermed Corp., Ltd. · LZA · Jan 15, 2009 · General Hospital

Device Facts

• Record ID: K081911
• Device Name: NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 15, 2009
• 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, powdered nitrile examination glove; blue color. Worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Device is disposable; intended for general medical use. Performance verified against ASTM D 6319-00a-05 standards for dimensions, physical properties, pinhole freedom, and powder residue. Biocompatibility confirmed via primary skin irritation and guinea pig sensitization testing.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D 6319-00a-05 standards for dimensions, physical properties, freedom from pinholes, and powder residue. Biocompatibility assessed via primary skin irritation in rabbits and guinea pig sensitization studies; all tests passed.

Technological Characteristics

Nitrile material. Dimensions, physical properties, pinhole freedom, and powder residue meet ASTM D 6319-00a-05. Biocompatibility confirmed via primary skin irritation and guinea pig sensitization. Non-sterile, powdered, blue color.

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.

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, Blue, Powdered (K002818)

Submission Summary (Full Text)

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# 1081911

# 510 (k) Summary

As Required by 21 section 807.92 (c)

- 1. Submitter Name: Siam Sempermed Corp., Ltd
- 352 Kanjanavanit Road. Pahtong Hatyai र्यं Address: Songkhla Thailand 90230
- 3. Phone: [phone]
- 4. Fax: [phone]
- Contract Person: Mrs. Parawan Paiyasan(Quality System Manager) છે.

727 787 7558

- 6. Date summary prepared: June 20,2008
- 7. Official Correspondent: Sempermed USA Inc.
- 8. Address: 13900 49th Street North
- Clearwater, USA , FL 33762
- 9. Phone: [phone]
- 10. Fax:
- 11. Contact person: Mr. William E. Harris

12. Device Trade or Proprietary Name: Non sterile, Powdered Nitrile Examination Glove, Blue.

- 13. Device Common or usual name: Examination glove
- 14. Device Classification Name: Nitrile Patient Examination Glove, Powdered , Blue color
- 15. Description of the Device:

Non sterile, Powdered Nitrile Examination Glove, Blue,

## 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, Powdered Nitrile Examination Glove, Blue are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------|------------------------------------|--------------------|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from pinholes | ASTM D 6319-00a-05 | Meets |
| Powder Residue | ASTM D 6319-00a-05 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| | Guinea Pig Sensitization | Passes |

JAN 1 5 2009

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#### 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.

## 19, Conclusion

It can be concluded that the Non sterile, Powdered Nitrile Examination Glove, Blue will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed devices. This device is safe and effective as the predicate device Siam Sempermed Nitrile, Examination Glove, Blue, Powdered. Indeed, it is 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: K002818 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO APPENDIX 1 |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result<br>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 | Identical (Not applicable) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Compatibility with environment and<br>other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

## JAN 1 5 2009

Re: K081911

Trade/Device Name: Non-Sterile, Powdered Nitrile Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 10, 2008 Received: December 15, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding . postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Cynthia V. Newton, M.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

510(k) Number (if known):

Device Name: Non-Sterile, Powdered Nitrile Examination Glove, Blue

Indications For Use: A patient examination glove is a disposable device intended for A pation. Oxamillian worn on the examiner's hand 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 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K081911