POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS

K013267 · Siam Sempermed Corp., Ltd. · LYY · Mar 8, 2002 · General Hospital

Device Facts

• Record ID: K013267
• Device Name: POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• 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 examiners hand or finger to prevent contamination between patient and examiner.

Device Story

Latex patient examination glove; powder-free; polymer-coated; non-chlorinated; non-sterile; white. Device worn on examiner's hand or finger during medical procedures. Acts as a barrier to prevent cross-contamination between patient and examiner. Manufactured to meet ASTM D3578-00 standards for dimensions, physical properties, and freedom from pinholes. Protein content limited to 50 micrograms or less per gram. Tested for primary dermal irritation and sensitization.

Clinical Evidence

Bench testing only. Testing included primary dermal irritation (16 CFR 1500.41) and guinea pig sensitization (Buehler method) confirming the device is not an irritant or sensitizer. Physical property testing confirmed compliance with ASTM D3578-00 and ASTM D5151 (pinhole testing).

Technological Characteristics

Latex material; polymer coated; non-chlorinated; non-sterile. Meets ASTM D3578-00 for dimensions, physical properties, and powder residue. Meets ASTM D5151 for freedom from pinholes. Protein content <= 50 ug/g.

Indications for Use

Indicated for use as a disposable medical glove 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.

Submission Summary (Full Text)

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Siam Sempermed Corp., Ltd.

110 Moo 8 Kanjanavanit Rd., Hat Yai, Songkhla, Thailand 90230 Tel: [phone] to 9 Fax: [phone]

#### MAR 8 2002

### 510 (k) SUMMARY

#### 1.0 APPLICANT:

Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION., Ltd. 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: [phone] OR 291 649 FAX: [phone]

### 2.0 CONTACT PERSON

Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION., Ltd. 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: [phone] OR 291 649 FAX: [phone]

Mrs. KATIE LEVINSON SEMPERMED USA Inc. 30798 US Hwy. 19 N Palm Harbor, USA FL 34684 TEL: [phone] FAX: [phone]

Page 1 (2)

3.0 Device Class: I Product code: 80LYY

4.0 Specification: Latex patient examination glove , Powder free coated , Non chilorinated -Class I 80LYY meets all of the requirements of ASTM standard D3578-00

5.0 Device Description: Latex Patient Examination glove , Powder free coated , Non chlorinated , non sterile (White)

50 micrograms or less of total water extractable protein per gram

6.0 Intended use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

#### 7.0 Surface treatment: polymer coated

8.0 Primary Dermal Irritation in Rabbits Guinea Pig Sensitization (Buehler) : Consumer Product Testing Co. Experiment reference number : T00-0175 , T01-0112

Conclusion : According to Federal Hazardous Substances Act Regulation , (16 CFR 1500.41), and under the conditions of this test . This test article is not a primary dermal irritant

: This test article is not a sensitizer in guinea pigs, under condition of this test.

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

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KO 3261

Siam Sempermed Corp., Ltd.

### 510 (k) SUMMARY

Page 2 (2)

CONFIDENTIAL

## 9.0 QUALITY CHARACTERISTICS

| Dimensions | Meet ASTM D 3578-00 |
|-----------------------|---------------------|
| Physical Properties | Meet ASTM D 3578-00 |
| Protein content | 50 ug/g or less |
| Residue Powder | Meet ASTM D 3578-00 |
| Freedom from pinholes | Meet ASTM D 3578-00 |
| | Meet ASTM D 5151 |

Glove , Non chlorinated 10. Conclusion: Siam Sempermed Latex Patient Examination Glove ,Powder free coated (White)

meet the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims (see 5.0 and 6.0 above)

P. Oberndörfer

Dr. POONSUK CHERDKIATGUMCHAI Chief Quality Officer August 22 ,2001

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

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

8 2002 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siam Sempermed Corporated, Limited C/O Ms. Katie Levinson Sempermed USA, Incorporated 30798 US Highway 19 North Palm Harbor, Florida 34684

Re: K013267

Trade/Device Name: Powder Free (polymer Coated) Non-Chlorinated White Latex Examination Gloves with Protein Content Labeling Claim ( 50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 14, 2002 Received: February 25, 2002

Dear Ms. Levinson :

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.

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

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#### Page 2 - Ms. Levinson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATION FOR USE

Siam Sempermed Corp., Ltd. Applicant:

510(k) Number: 013267

Device Name: Latex Examination Glove, Powder-Free, Coated, Non-Chlorinated, White with a Protein Content of 50 Micrograms or Less of Total Water Extractable Protein per Gram

Indications For Use:

A Patient examination glove is a disposable device intended for medical A r adom examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number _

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Concurrence of CDRH, Office of Device Evaluation (ODE)