POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE

K011613 · Shield Gloves Manufacturer (M) Sdn Bhd · LZA · Sep 17, 2001 · General Hospital

Device Facts

• Record ID: K011613
• Device Name: POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
• Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Sep 17, 2001
• 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 patient.

Device Story

Barrier-Pro synthetic butadiene co-polymer examination glove; non-sterile, powder-free, green. Designed for use by healthcare personnel to provide a physical barrier against contamination during patient examinations. Device functions as a protective hand covering; manufactured from synthetic butadiene co-polymer. Tested for water-tightness (1,000 ml leak test) and biocompatibility (non-irritant, non-sensitizing). Output is the physical barrier provided to the clinician. Benefits include reduced risk of cross-contamination between healthcare workers and patients in clinical settings.

Clinical Evidence

Bench testing only. Includes physical property testing (tensile strength, elongation at break), water-tightness testing (1,000 ml leak test, 125 samples per size, 2.5% AQL), and biocompatibility testing (dermal irritation and sensitization). Residual powder content measured per ASTM D6124-00.

Technological Characteristics

Material: Synthetic butadiene co-polymer. Form factor: Powder-free examination glove. Standards: Meets ASTM D3578-00 (except elongation at break). Dimensions: 242mm length, 0.08mm minimum thickness. Biocompatibility: Non-irritant, non-sensitizing. Sterilization: Non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a medical glove 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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# SEP 1 7 2001

### APPENDIX K

### 510(k) SUMMARY

## SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWIDER-FREE, "BARRIER-PROw", SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN

KO11613

Contact person : Ong Lay Mau

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

### Device Information:

# Trade Name - See above complete title for this exam glove.

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 the requirements of ASTM-D3578-01 Standard Specification for Latex Examination Gloves for Medical Application ( except for the elongation at break parameter.

### Device Description:

Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex 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 D3578-99 | Shield Gloves |
|-------------------------------|---------------------------------|----------------------------|
| 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 -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |

(Revised 8-9-01)
(Revised 9-10-01)

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| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|--------------|------------------|------|---------------------|------|
| | ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP |
| | Mpa | Mpa | % | % |
| Before Aging | 14.0 | | 700 | |
| X-Small | | 25.3 | | 840 |
| Small | | 26.0 | | 850 |
| Medium | | 28.9 | | 860 |
| Large | | 22.0 | | 840 |
| After Aging | 14.0 | | 500 | |
| X-Small | | 21.3 | | 890 |
| Small | | 23.4 | | 930 |
| Medium | | 23.6 | | 940 |
| Large | | 21.7 | | 900 |

- 2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1128
### 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>1128 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| | X-Small | 125 | Yes | 2 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |
| AGED | | | | |
| | X-Small | 125 | Yes | 1 |
| | Small | 125 | Yes | 2 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |

The above figures are within the gloves of 2.5% AQL.

. FDA/ASTM D3578-00 requirements for latex exam

89

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#### Biocompatibility ﻧ

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 | Shield'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 this Synthetic Butadiene Co-Polymer glove.

- meets/exceeds ASTM- D3578 Standard Specifications For Latex Examination Glove, except for 1. the elongation at break parameter,
- meets FDA pinhole requirements, ಗಳ
- meets FDA claim criterion of a powder free glove, ਡ

510(K) Summary Page 3 of 3

Revised 8-9-01)
Revised 9-10-01)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2001

Shield Gloves Manufacturing (M) Sdn Bhd C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550

### Re: K011613

Trade/Device Name: Powder-Free Green "Barrier-Pro™" Synthetic Butadiene Copolymer Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 9, 2001 Received: July 13, 2001

Dear Ms. Tucker:

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. Tucker

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and squirements, including, but not limited to: registration 1 ou must comply with and are rabeling (21 CFR Part 801); good manufacturing practice and ilsung (21 OF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirences as betronic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will and in the FDA finding of substantial equivalence of your device to a premaired 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 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 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. Ulstanski

Timoth 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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# INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn. Bhd.

### Koll613 510K Number:

# Device Name: NON-STERILE, POWDER-FREE, "BARREER-PROTH" SYRTHETIC NON-STERILE, POWDER-FREE, "BARIOVES, COLOR: GREEN

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 ...

(Revised 9-10-01)

²
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Device 10(k) Number