NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE

K020317 · Sgmp Co., Ltd. · LZA · Feb 14, 2002 · General Hospital

Device Facts

• Record ID: K020317
• Device Name: NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
• Applicant: Sgmp Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Non-sterile, powder-free, green-colored synthetic butadiene copolymer examination gloves; worn on hands by healthcare personnel; provides physical barrier to prevent cross-contamination between clinician and patient; manufactured to meet ASTM D6319-00a standards; tested for water-tightness (pinhole resistance), tensile strength, ultimate elongation, and biocompatibility (non-irritant, non-sensitizer); residual powder content below 2 mg/glove; cornstarch-free.

Clinical Evidence

Bench testing only. Testing included water leak tests (1,000 ml) on 125 pieces per size, demonstrating compliance with 2.5% AQL. Physical property testing (tensile strength, ultimate elongation) performed before and after aging per ASTM D6319-00a. Biocompatibility testing confirmed no dermal irritation or skin sensitization. Residual powder content measured per ASTM D6124-00.

Technological Characteristics

Synthetic butadiene copolymer; powder-free; green color; non-sterile. Dimensions: 242mm length, 0.08mm minimum thickness (palm/finger). Physical properties: tensile strength 15.3-19.4 MPa, ultimate elongation 650-720%. Meets ASTM D6319-00a standards. Residual powder content 0.7-1.5 mg/glove.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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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FEB 14 2002

### 510(k) SUMMARY

### SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE GREEN COLOR SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES

### Contact person : Cheah Chor Hee

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

### Device Information:

Device Name - POWDER FREE GREEN COLOR SYNTHETIC POLYBUTADIENE COPOLYMER EXAM GLOVES

Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I latex patient examination glove 80LZA, powder free and meeting all Classinouncents of ASTM-D6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application.

### Device Description:

Class I nitrile patient examination glove 80LZA, powder free and meeting all the requirements of ASTM Class Finance partierd Specification for nitrile Examination Gloves for Medical Application, except for the elongation at break parameter.

### Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Technological Characteristics of Device:

### 1. Dimension

| DIMENSION | ASTM D6319-00a | SGMP |
|--------------------|---------------------------------|--------------|
| X-Small | 70 mm +/- 10 mm | 70 - 75 mm |
| Small | 80 mm +/- 10mm | 80 - 85 mm |
| Medium | 95 mm +/- 10mm | 90 - 97 mm |
| Large | 111mm +/- 10mm | 105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 242mm |
| Thickness - Finger | 0.08mm min | 0.08 mm min |
| Thickness - Palm | 0.08mm min | 0.08 mm min |

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| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------------------------------|--------------------|-------------------------------------|---------------------|-------------------------------|
| | ASTM<br>D 6319-00a | SGMP's | ASTM<br>D 6319-00a | SGMP's |
| Before Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0<br>MPa | 16.5<br>16.0<br>15.3<br>17.6<br>MPa | 500<br>% | 650<br>680<br>700<br>670<br>% |
| After Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0 | 17.1<br>18.0<br>17.5<br>19.4 | 400 | 680<br>670<br>690<br>720 |

## 2. Physical Properties (ASTM-D6319-00a Standard Specification for Nitrile Exam Gloves) on Lot# Exp 02/01

### 3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:

| BATCH #<br>Exp | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| 02/01 | X-Small | 125 | Yes | 1 |
| 02/01 | Small | 125 | No | 0 |
| 02/01 | Medium | 125 | Yes | 2 |
| 02/01 | Large | 125 | Yes | 1 |
| AGED | | | | |
| 02/01 | X-Small | 125 | No | 0 |
| 02/01 | Small | 125 | Yes | 1 |
| 02/01 | Medium | 125 | Yes | 1 |
| 02/01 | Large | 125 | No | 0 |

The above figures are within the ASTM D3578-00 requirements for exam gloves of 2.5% AQL.

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#### Biocompatibility 4.

The bio-compatibility test results show that the glove is neither a dermal irritant nor a skin sensitizer.

# 5. Total Residual Powder Content & Presence of Cornstarch

| TESTS<br>REQUIREMENT | FDA | SGMP's |
|------------------------------------------------|----------------|------------------------------------------------|
| Residual Powder<br>Content<br>(ASTM D 6124-00) | 2 mg/glove max | Range: 0.7-1.5mg/glove<br>Mean : 1.05 mg/glove |
| Presence of Cornstarch | Negative | Negative |

### Conclusion:-

The data presented indicate that the Powder Free Green Color Synthetic examination glove

1. meets/exceeds ASTM- D6319-00a Standard Specifications For nitrile Examination Glove,

- 2. meets FDA pinhole requirements,
- 3. meets FDA claim criterion of a powder free glove,

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 1 4 2002

SGMP Company Limited C/O Ms. Janna Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434

Re: K020317

K020317
Trade/Device Name: Non-Sterile Powder Free Green "Barrier-Pro" Synthetic Butadiene Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LZA Dated: January 22, 2002 Received: January 30, 2001

Dear Ms. Tucker:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(t) presidentially equivalent (for the referenced above and have decemined the use its marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed profithe Medical Devic indications for use stated in the cholorate, we segment date of the Medical Device interstate commerce prior to May 20, 1970, also started in accordance with the provisions of Amendments, or to devices that have book for that do not require approval of a prematice the Federal Food, Drug, and Cosment Act (110) e. market the device, subject to the general
approval application (PMA). You may, therefore, softhe Aat include approval application (1 Mrx). Fou may strong provisions of the Act include controls provisions of the Act. The genting of devices, good manufacturing practice, requirements for anitations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) of class III If your device is classified (SCC above) into cantrols. Existing major regulations affecting (PMA), it may be subject to such additional controllar Stile 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, In the Federal your device can be found in the Code of Peacharding your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issualled of a substance of a subscription with other requirements

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### Page 2 - Ms. Tucker

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and sugments, including, but not limited to: registration You must comply with an the Hecker & required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laseling (21 cms (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 This letter will anow you to begin mainting of substantial equivalence of your device to JTV(K) promatics nourieans - 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 IT you desire specific ac not 10- your for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Colliphance at (301) 89 . Intact 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 noutication (21011111 art 00197).
the Act may be obtained from the Division of Small Manufacturers (1994) 1996 (197 the Act may be obtained in the enumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski

Jlatowski 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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### INDICATIONS FOR USE STATEMENT

Applicant: SGMP CO LTD

...

KO20317 510K Number:

Device Name: Non-sterile Powder Free Green Color "Barrier-Pro" Synthetic Butadiene Copolymer Examination Gloves

Indications for Use :

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ... ... ... Per 21 CFR 801.109

OR

Over-The-Counter ... ... ... ... ...

Olin S. Lium

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

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