STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)

K051329 · Siam Sempermed Corp., Ltd. · LYY · Jul 19, 2005 · General Hospital

Device Facts

• Record ID: K051329
• Device Name: STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jul 19, 2005
• 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

Sterile, powder-free latex examination glove with polymer coating; protein content ≤ 50 µg/g. Device worn on examiner's hand; acts as barrier to prevent cross-contamination between patient and examiner. Used in clinical settings; operated by healthcare professionals. Provides physical barrier protection; reduces risk of contamination during patient examinations.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D3578-2001-ae2 (dimensions, physical properties, freedom from pinholes), ASTM D6124-2001 (powder-free residue ≤ 2 mg/glove), and ASTM D5712-99 (protein level < 50 µg/g). Biocompatibility confirmed via primary skin irritation and guinea pig sensitization testing.

Technological Characteristics

Latex examination glove with polymer coating. Standards: ASTM D3578-2001-ae2 (dimensions, physical properties, pinholes), ASTM D6124-2001 (powder residue), ASTM D5712-99 (protein). Biocompatibility: passes primary skin irritation and guinea pig sensitization. Sterile.

Indications for Use

Indicated for use as a patient examination glove, a disposable device worn on the examiner's hand or finger to prevent 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 Examination Glove, Powder free (K970794)

Submission Summary (Full Text)

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

- 1. Submitter Name: Siam Sempermed Corp., Ltd
## JUL 1 9 2005

- 110 Kanjanavanit Road. Pathong Hatyai 2. Address: Songkhla. Thailand 90230
- ([phone]. Phone:
- ([phone] Fax: 4.
- 5. Contract Person: Mrs. Sureerat Choosri (Product Manager)
- Date summary prepared: Mar 31, 2005 6.
- Official Correspondent: Sempermed USA Inc. 7.
- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:
- 12. Device Trade or Proprietary Name: Sterile, powder-free latex examination gloves with polymer coating 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:

ISterile, powder-free latex examination gloves with polymer coating 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 :

Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------|----------------------------------------------------------------|--------------------|
| Dimensions | ASTM D 3578-2001-ae2 | Meets |
| Physical Properties | ASTM D 3578-2001-ae2 | Meets |
| Freedom from pinholes | ASTM D 3578-2001-ae2 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | $≤$ 2 mg/glove |
| Protein Level | ASTM D 5712-99 | $<$ 50 µg/g |
| Biocompatability | Primary Skin Irritation in Rabbits<br>Guinea Pig Sensitization | Passes<br>Passes |

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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 Sterile, powder-free latex examination gloves with polymer coating 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 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 as below.

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

| FDA file reference number | 510k number: k970794 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Attachments inside notification 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 | different |
| 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) |

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The caduceus is depicted as a stylized design with a staff and a serpent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 9 2005

Siam Sempermed Corporation Lịmited. c/o Mr. William E. Harris Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762

Re: K051329

K031527
Trade/Device Name: Sterile Powder-Free Latex Examination Glove with Polymer Coating and Protein Claim (50 micrograms or less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYY Dated: July 6, 2005 Received: July 11, 2005

Dear Mr. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) pe device is substantially equivalent (for the indications felerenced above and nave acterimes acterimes and one ices marketed in interstate for use stated in the encrosule) to regars actual date of the Medical Device Amendments, or to commerce price to May 20, 1978, as can as a condance with the provisions of the Federal Food, Drug, devices mat have been recuired in assessmon in assessor approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (P and Cosmetic Act (1101) that do novement to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the free 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 If your device is classified (soo aboro) and existing major regulations affecting your device can thay be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouchs 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 Please be advised that IDA s issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other wort that FDA has made a decommances as administered by other Federal agencies. You must of any Federal statutes and regulations daminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 510(k) I his letter will anow you to begin manteling of substantial equivalence of your device to a legally premarket notheation: "The PDA missification 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 If you desire specific advice for your acon 1001) 276-0115. Also, please note the regulation entitled, a Contact the Office of Complanes at (210) = 16 = 21 = 21 = 21 807.97). You may obtain "Misbranding by reference to premanter nouthead in the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990s (23,000 other general International on your responsive and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (800) o Manufacturers, International and Ochoanhows: http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cluts

Anita Chiu, 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

510(k) Number (if known): k051329

Device Name: Sterfle Powder-Free Latex Examination Glove with Polymer Coating and Protein Claim (1)
1988 (1994) 1994 (1994) 1994 (1994) (50 micrograms or less)

Indications For Use: A patient examination glove is a disposable intended for medical purposes A patient 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, MD 2/18/03
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental De

510(k) Number: A051329

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