NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES

K033887 · Yty Industry (Manjung) Sdn Bhd · LZA · Mar 2, 2004 · General Hospital

Device Facts

• Record ID: K033887
• Device Name: NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Non-sterile, powder-free patient examination glove made from BarrierPro™ polybutadiene-based synthetic copolymer rubber latex. Worn by healthcare personnel to provide a barrier against contamination between the examiner and the patient's body, fluids, waste, or environment. Device is blue or white in color. Performance verified against ASTM D6319-00a standards for watertight integrity, dimensions, thickness, and physical properties (tensile strength/elongation). Biocompatibility confirmed via primary dermal irritation and guinea pig sensitization tests.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000ml, AQL 2.5), physical dimensions (length/width), thickness (min 0.08mm), and physical properties (tensile strength 16-21 MPa, elongation 610-710%) per ASTM D6319-00a. Biocompatibility testing included primary dermal irritation and Guinea Pig (Buehler) sensitization tests. All results met or exceeded ASTM and FDA requirements.

Technological Characteristics

Material: BarrierPro™ polybutadiene-based synthetic copolymer rubber latex. Form factor: Disposable, powder-free examination glove. Standards: ASTM D6319-00a. Physical properties: Min 0.08mm thickness, 240mm minimum length. Biocompatibility: Passed primary dermal irritation and sensitization testing.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or fingers 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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a black abstract symbol. The symbol is composed of geometric shapes, including a curved line at the top and several rectangular shapes below. The overall design appears symmetrical and stylized.

# YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia, Tel : [phone] (Hunting Line), 6792443 & 6792445 Fax : [phone]

- MAR 2 2004
1.0

2.0

K033887

APPENDIX-J SMDA 510 (K) SUMMARY YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan Perak Darul Ridzuan MALAYSIA 605-6792288 605-6791188

1. MR. MOH UNG NANG Name of Contact Person

Official Correspondence 2. MS. JANNA TUCKER

Date of Summary Prepared

#### 3.0 Name of Device

Submitter

Tel

Fax

| Trade Name: | Non-Sterile Blue & White Colour Powder Free Barrier Pro™<br>Polybutadiene Copolymer Examination Gloves |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Synthetic Rubber Examination Gloves |
| Classification Name: | Patient Examination Glove, Powder Free |

October 30, 2003

### Identification of The Legally Marketed Devices 4.0

Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D6319-00a63, Standard Specification for Nitrile Gloves for Medical Application.

#### 5.0 Description of The Device

Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.

{1}------------------------------------------------

K033887

## The Intended Use of Glove 6.0

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

#### Summary of Performance Data: 7.0

Performance data of gloves based on ASTM D6319-00a" and FDA 1000ML watertight test.

| TEST | ASTM D6319-00a3 | POWDER FREE BARRIER<br>PROTM EXAM. GLOVES |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------|
| 1. Watertight (1000ml) | Multiple Normal<br>GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm)<br>Size<br>XS<br>S<br>M<br>L<br>XL | Min 220<br>Min 220<br>Min 230<br>Min 230<br>- | 240 mm minimum for all sizes |
| 3. Palm width (mm)<br>Size<br>XS<br>S<br>M<br>L<br>XL | $70 \pm 10$<br>$80 \pm 10$<br>$95 \pm 10$<br>$111 \pm 10$<br>- | 73 - 78<br>83 - 88<br>93 - 98<br>103 - 107 |
| 4. Thickness (mm)<br>(Single Layer)<br>Finger<br>Palm | Min 0.05<br>Min 0.05 | Min 0.08<br>Min 0.08 |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%)<br>After Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 500<br>Min 14<br>Min 400 | 17-21<br>630 - 710<br>16-20<br>610-670 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |

{2}------------------------------------------------

K03-3887

- The performance data of the glove as shown above meet the ASTM D6319-00a83 8.0 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion

We concluded that the Multiple Private Labeled Non-Sterile Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Glove meets:

- ASTM D6319-00a63 Standard -
- -FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a83

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

MAR - 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

YTY Industry (Manjung) SDN. BHD. Ms. Janna P. Tucker Official Correspondents Tucker & Assoclates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550

Re: K033887

Trade/Device Name: Non-Sterile, Blue & White Colour Powder Free Barrier ProTM Polybutadiene Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 10, 2003 Received: December 15, 2003

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.

{4}------------------------------------------------

Page 2 - Ms. Falk

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 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 (OS) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Chiu Lin, Ph. D.

Chiu Lin, Ph., Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): ... ...... K033887

Non-Sterile, Blue & White Colour Powder Free Barrier Pro™ Device Name: Polybutadiene Copolymer Examination Gloves

Indications For Use:

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Ques

(Division Sr. Off) Division a thesiology, General Hospital, Infection Control, Dental De

510(k) Number: K033887

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)