MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G

K031384 · Yty Industry (Manjung) Sdn Bhd · LZA · Jun 17, 2003 · General Hospital

Device Facts

• Record ID: K031384
• Device Name: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jun 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for 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 polyurethane patient examination gloves; worn by healthcare personnel to prevent cross-contamination between wearer and patient/environment. Device acts as physical barrier. Used in clinical settings. Performance verified via ASTM D6319-00a standards for watertight integrity, dimensions, physical properties (tensile strength/elongation), and biocompatibility (dermal irritation/sensitization).

Clinical Evidence

Bench testing only. Performance data includes watertight (1000ml) testing (AQL 2.5), dimensions, thickness, tensile strength (16-23 MPa), ultimate elongation (600-800%), and powder content (<2 mg/glove). Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests. All results met ASTM D6319-00a requirements.

Technological Characteristics

Material: Polyurethane. Form: Powder-free, white color, non-sterile examination glove. Standards: ASTM D6319-00a. Physical properties: Tensile strength 16-23 MPa, elongation 600-800%. Watertight: 1000ml test (AQL 2.5).

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.

Predicate Devices

• K011198

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a black and white symbol that appears to be a stylized representation of an object or emblem. It features a horizontal curved line at the top, resembling an arch or handle, supported by a structure composed of vertical and horizontal lines. The overall design is symmetrical and geometric, giving it a somewhat abstract and symbolic appearance.

# (TY 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]

**JUN 17 2003**

KO 31384

### APPENDIX-H

| 1.0 | | SMDA 510 (K) SUMMARY |
|-----|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| 2.0 | Submitter | YTY Industry (Manjung) Sdn Bhd<br>Lot 1422-1424, Batu 10 Lekir<br>32020 Sitiawan<br>Perak Darul Ridzuan<br>MALAYSIA |
| | Tel | 605-6792288 |
| | Fax | 605-6791188 |
| | Name of Contact Person | 1. MR. MOH UNG NANG |
| | Official Correspondence | 2. MS. JANNA TUCKER |
| | Date of Summary Prepared | May 16, 2003 |

#### 3.0 Name of Device

Trade Name: MULTIPLE PRIVATE LABELS, NON-STERILE, POWDER-FREE POLYURETHANE, WHITE COLOR EXAMINATION GLOVES

Common Name Exam Glove

Classification Name Patient Examination Glove

#### 4.0 Identification of The Legally Marketed Devices

Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"

#### રું. વ Description of The Device

Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a8 and FDA Water leak test.

#### 6.0 The Intended Use of Glove

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.

Revised 6-4-03
Page 1 of 3

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## APPENDIX H PAGE 2

### Summary of Performance Data: 7.0

Performance data of gloves based on ASTM D6319-00a22 and FDA 1000ML watertight test.

| TEST | ASTM D6319-00ae3 | POWDER FREE<br>POLYURETHANE EXAM.<br>GLOVES |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------|
| 1. Watertight (1000ml) | Multiple Normal<br>GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm)<br>Size 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 XS<br>S<br>M<br>L<br>XL | 70 ± 10<br>80 ± 10<br>95 ± 10<br>110 ± 10<br>- | 73-78<br>83 - 88<br>93-98<br>103 - 107 |
| 4. Thickness (mm)<br>(Single Layer) | | |
| Finger<br>Palm | Min 0.05<br>Min 0.05 | Min 0.13<br>Min 0.11 |
| 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 | 16-23<br>600-800<br>20 - 23<br>600-720 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |

Page 2 of 3

Revised 6-4-03 JT

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# APPENDIX H PAGE 3

- The performance data of the glove as shown above meet the ASTM D6319-00a23 8.0 Standard Powder content is below 2 mg per glove.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.

4031284

- 10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile, Powder Free Polyurethane White Color Examination Gloves meets:

- ASTM D6319-00a53Standard ー
- -FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM » D6319-00a83
- We feel this glove is substantially equivalent to the glove approved in K011198.

Page 3 of 3

Revised 6-4-03 JT

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Image /page/3/Picture/2 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. Inside the circle is a stylized image of a bird in flight. The bird is composed of three curved lines that represent the body and wings, and two curved lines that represent the tail.

JUN 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emarald Sparks. Nevada 89434-9550

Re: K031384

Trade/Device Name: Multiple Private Labeled, Non-Sterile, Powder-Free Polyurethane White Color. Examination Gloves (Intacta* Polyurthane Gloves) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 3, 2003 Received: June 5, 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.

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Page 2 - Ms. Tucker

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 (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). 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,

Susan Benon

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

YTY INDUSTRY (MANJUNG) SDN BHD Applicant:

510K Number: 15 031384

Device Name: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA* POLYURETHANE 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.

4.

| | WAN | Concurrence of CDRH Office of Device Evaluation (ODE) |
|------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------|
| (Division Sign-Off)<br>510(k) Number :_ | Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices<br>K621384 | |
| Prescription Use .<br>Per 21 CFR 801.109 | OR | Over-The-Counter |