NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM

K024106 · Siam Sempermed Corp., Ltd. · LYY · Dec 20, 2002 · General Hospital

Device Facts

• Record ID: K024106
• Device Name: NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

Non-sterile, powder-free latex examination glove; features polymer coating and vitamin E; protein content limited to 50 micrograms or less. Device worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Intended for general medical examination use. Substantially equivalent to predicate latex examination gloves.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to predicate device.

Technological Characteristics

Material: Latex. Features: Polymer coating, vitamin E additive, low protein content (≤ 50 micrograms). Form factor: Disposable examination glove. Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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 (K970794)

Submission Summary (Full Text)

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K024106

3 - 1

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

- 1. Submitter Name: Siam Sempermed Corp., Ltd
110 Moo 8 Kanjanavanit Road. Pathong Hatyai 2. Address: Songkhia. Thailand 90230

- 3. Phone: (++66) 074 291 648
- 4. Fax: (++66) 074 291 650

5. Contract Person: Dr. Poonsuk Cherdkistgumchai (Chief Quality Officer)

6. Date summary prepared: September 24, 2002

- 7. Official Correspondent: Sempermed USA Inc.
- 8. Address: 30798 US Hwy. 19N

Palm Harbor, USA , FL 34684

- 9. Phone: [phone]
- 10. Fax: [phone]
- Mr. William E Harris 11. Contact person:
- 12. Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E and protein claim (50 micrograms or less).
- 13. Device Common or usual name: Examination glove
- 14. Device Classification Name: Glove, Patient Examination, Latex
- 15. Substantial Equivalency is claimed against the following device :

Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #k970794 (refer to Appendix I for FDA website printout.

This notification for the non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less) is of the ABBREVIATED type as per the declaration of conformity on page 4 of this summary.

- 16. Description of the Device:
Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less).

- 17. Intended use of the device:
This device is a disposable device intended for medical purpose that is worn on the exammer 's hand to prevent contamination between patient and examiner

- 18. Safety and effectiveness of the device:
This device is safe and effective as the predicate device Siam Sempermed Latex Examination Glove , Powder free. Indeed . it is equivalent

This is better expressed in the tabulated comparison (Paragraph 19 below)

19. Summary comparing technological characteristics with other predicate device:

General comparison result between non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less) and predicate device (Siam Sempermed Latex Examination Glove, Powder Free) is tabulated below.

This document and its connents are confidential. Do not discuss with in give access to people not designated.

DEC 2 0 2002

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| FDA file reference number | 510k number: k970794 |
|-----------------------------------------------------|------------------------------------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO APPENDIX 1 |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| | 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 |
| 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) |

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

KO2 4106

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This document and its contents are confidential. Do not discuss with or give access to people not designated.

Image /page/1/Picture/3 description: The image shows the word "CONFIDENTIAL" in large, bold, black letters. The letters are slightly tilted to the right. The font appears to be a sans-serif typeface.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20 2002

Siam Sempermed Corporation Limited C/O Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K024106

Trade/Device Name: Non-Sterile, Powder-Free Latex Examination Gloves with · Polymer Coating, Vitamin E and Protein Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 11, 2002 Received: December 13, 2002

Dear Mr. Devine

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. Devine

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

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

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## INDICATIONS FOR USE

Applicant: _ Siam Sempermed Corp. , Ltd.

510(k) Number: K024106

.

Device Name: Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and 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 to prevent contamination between patient and examiner.

SBdy Clin

ion of Anesthesiology, General Hospital, tion Control, Dental Devices

510(k) Number. KC24106