SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E

K014112 · Siam Sempermed Corp., Ltd. · LYY · Feb 28, 2002 · General Hospital

Device Facts

• Record ID: K014112
• Device Name: SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 28, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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

Device Story

SATARI® latex patient examination glove; single-side polymer-coated; non-sterile; powdered. Designed for use by healthcare professionals in clinical settings to provide a barrier against cross-contamination between patient and examiner. Device is worn on the hand. Provides physical protection; reduces potential for protein-related allergic reactions via low protein content (200 µg or less per gram).

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Latex patient examination glove; single-side polymer coated; non-sterile. Protein content: ≤ 200 µg/g. Residual powder: ≤ 10 mg/dm². Regulatory Class I; Product Code LYY.

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical examiners to prevent cross-contamination between the patient and the 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 Polymer powder free (K981096)

Submission Summary (Full Text)

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K01412

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

FEB 2 8 2002

1-Submitter Name: Siam Sempermed Corp., Ltd

110 Moo 8 Kanjanavanit Road. Pathong Hatyai 2-Address: Songkhla. Thailand 90230

| 3-Phone: | (++66) 074 291 648 |
|--------------------------------------|------------------------------------------------------|
| 4-Fax: | (++66) 074 291 650 |
| 5-Contact Person: | Dr Poonsuk Cherdkiatgumchai (Chief Quality Officer) |
| 6-Date summary prepared: | December 7th, 2001 |
| 7- Official Correspondent: | Mansour Consulting |
| 8- Address: | 1308 Morningside Park Dr<br>Alpharetta, GA 30022 USA |
| 9- Phone: | [phone] |
| 10- Fax: | [phone] |
| 11- Contact person: | Jay Mansour, president |
| 12-Device Trade or Proprietary Name: | SATARI® latex patient |

examination powdered glove single side polymer coated, non sterile, 200 µg or less of total water extractable protein per gram, 10 mg/dm2 or less of residual powder

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 Polymer powder free, 510k #k981096 (refer to Appendix 2 for FDA website printout. This notification for the SATARI® latex examination glove is of the ABBREVIATED type as per the declaration of conformity on page 4 of this summary

### 11-Description of the Device:

SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 200 ug or less of total water extractable protein per gram, 10 mg/dm- or less of residual powder

## 12-Intended use of the device: (Indications for use typed on a separate FDA form)

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

#### 13-Safety and effectiveness of the device:

This device is safe and effective as the predicate device Siam Sempermed Latex Patient Examination Glove polymer, powder-free. Indeed, it is equivalent.

This is better expressed in the tabulated comparison (Paragraph 14 below)

## 14-Summary comparing technological characteristics with other predicate device:

PAGE 3.1

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General comparison result between SATARI® latex examination glove and the predicate device (Siam Sempermed Latex Patient Examination Glove polymer, powder-free) is tabulated below.

014112

Technical comparison of specific elements is attached in the main submission

| FDA file reference number | 510k 970794 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO APPENDIX 2 |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result<br>REFER TO ADDITIONAL TECHNICAL<br>COMPARATIVE TABLE WITHIN 510K SUBMISSION |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| 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<br>environment 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes and a flowing tail.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

Siam Sempermed Corporation Limited C/O Mr. Jay Mansour Mansour Consulting 1308 Morningside Park Drive Alpharetta, Georgia 30022

Re: K014112

Trade/Device Name: Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim ( 200 Micrograms or Less) Polymer Coated White, Pink and Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 10, 2001 Received: December 14, 2001

Dear Mr. Mansour:

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. Mansour

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 a!l 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 Ulatowski

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

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510(k) Number (if known): K014112
SATART® LATEX PATIENT EXAMINATION POWDERED GLOVE,
Device Name: SINGLE SIDE POLYMER COATED, NON STERILE 200μg OR LESS
OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM, 10mg/dm² or LESS
Indications For Use: (white, Pink, and Blue)

THIS DEVICE IS A DISPASABLE DEVICE INTENDED for MEDICAL PURPOSES THAT IS WERN ON THE EXAMINER'S Official T AND HAND TO PREVENT CONTAMINATION SETWEEN EXAMINER

**PLEASE DO NOT WRITE BELOW THIS LINE - CONTROLLED DOCUMENT**

**Commission of CSRA, Office of Dispute Resolution (ODR)**

Qhin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ! 10(k) Number

Prescription Use (Per 21 CFR 801. 109)

OR

**Over-The-Counter Use** X

**(Optional Format 1-2-85)**

**Page 4 of**