NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL

K100907 · Siam Sempermed Corp., Ltd. · LYY · Jul 9, 2010 · General Hospital

Device Facts

• Record ID: K100907
• Device Name: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Abbreviated
• 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 hand or finger to prevent contamination between patient and examiner.

Device Story

Non-sterile, powder-free latex examination glove; intended for medical use to prevent cross-contamination between patient and examiner. Worn on examiner's hand/finger. Device provides physical barrier; manufactured to meet ASTM D 3578-05-e1 standards for dimensions, tensile strength, elongation, and protein content (≤50 micrograms). Used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D 3578-05-e1 standards for dimensions, tensile strength, ultimate elongation, freedom from holes (AQL 2.5), powder-free residue, and protein levels (≤50 micrograms). Biocompatibility confirmed via primary skin irritation and guinea pig sensitization studies.

Technological Characteristics

Latex examination glove; powder-free. Meets ASTM D 3578-05-e1 standards for physical dimensions, tensile strength, elongation, and protein content (≤50 micrograms). Biocompatibility validated via skin irritation and sensitization testing.

Indications for Use

Indicated for use as a disposable medical 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 Latex Patient Examination Glove, Powder free and protein claim (50 micrograms or less) (K970794)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL·- 9 2010

## 510 (k) Summary As Required by 21 section 807.92 ( c)

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

6. Date summary prepared: 15 March , 2010

- 7. Official Correspondent: Sempermed USA Inc.
- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 10. Fax: [phone]
- Mr. William E. Harris 11. Contact person:
- 12. Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).
- 13. Device Common or usual name: Examination glove
- 14. Device Classification Name: Glove , Patient Examination , Latex
- 15. Description of the Device:

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less). 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 :(According Guidance for Industry and FDA Staff - Medical Glove Guidance Manual(January 22, 2008))

Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less) are summarized with the following technological characteristics:

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------------------------------------------------|---------------------------------------|--------------------|
| Dimensions: overall length; width, palm<br>and finger thickness | ASTM D 3578-05-e1 | Meets |
| Tensile strength: before and after aging | ASTM D 3578-05-el | Meets |
| Ultimate elongation: before and after<br>aging | ASTM D 3578-05-e1 | Meets |
| Freedom from holes: pinholes AQL 2.5 | ASTM D 3578-05-e1 | Meets |
| Powder Free Residue | ASTM D 3578-05-e1 | Meets |
| Protein Level | ASTM D 3578-05-e1 | Meets |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes |
| | Guinea Pig Sensitization | Passes |

{1}------------------------------------------------

### 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 Non-Sterile, powder-frec latex examination gloves and protein claim (50 micrograms or less) 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 Latex Pattent Examination Glove , Powder free and protein claim (50 micrograms or less). 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 : K970794 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO APPENDIX I |
| 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 | Identical |
| 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 | Identical (Not applicable) |
| Compatibility with environment<br>and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (Not applicable) |
| Thermal safety | Identical (Not applicable) |
| Radiation safety | Identical (Not applicable) |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.

SEP 9 2010 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

Re: K100907

Trade/Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 16, 2010 Received: June 22, 2010

Dear Mr. Harris:

This letter corrects our substantially equivalent letter of July 9, 2010.

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 (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 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.

{3}------------------------------------------------

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. wat
Anthony D. Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

K100907 510(k) Number (if known):

Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less).

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 between patient and examiner.

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

KIDO907 510(k) Number:

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

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)

Page 1 of 1

でア