EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE

K024355 · Yty Industry (Manjung) Sdn Bhd · LYY · Feb 3, 2003 · General Hospital

Device Facts

• Record ID: K024355
• Device Name: EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Feb 3, 2003
• 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, powdered, natural or colored latex examination gloves; worn on hands of healthcare personnel; acts as protective barrier to prevent cross-contamination between personnel and patient/environment. Device meets ASTM D3578-01 standards for physical properties, dimensions, and watertight integrity. Used in clinical settings; operated by healthcare professionals.

Clinical Evidence

Bench testing only. Device demonstrated compliance with ASTM D3578-01 (watertight test, dimensions, physical properties including tensile strength and elongation before/after aging) and ASTM D6124-01 (powder content). Biocompatibility testing included dermal sensitization and primary skin irritation.

Technological Characteristics

Natural latex rubber; powdered with absorbable dusting powder. Dimensions and physical properties meet ASTM D3578-01. Tested per ASTM D5712-99, D5151-99, D6124-01, and ISO 2859. Non-sterile.

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

• K943807
• K974191
• K023590

Submission Summary (Full Text)

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

# YTY INDUSTRY (MANJUNG) SDN. BHD.

Company No : 380830-P)

mpany No : 000304 7
1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysi�EB 0 3 2003 Tel : [phone] (Hunting Line), 6792443 & 6792445 Fax : [phone]

APPENDIX I.

| 1.0 | | 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 | 1. JANNA TUCKER |
| | Date of Summary Prepared | November 30, 2002 |

#### 3.0 Name of Device

| Trade Name | Non-Sterile Powdered Natural or Colored Latex Examination Gloves (Multiple Private Labels) |
|---------------------|--------------------------------------------------------------------------------------------|
| Common Name | Exam Glove |
| Classification Name | Patient Examination Glove |

#### 4.0 Identification of The Legally Marketed Devices

Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirements of ASTM Standard D3578-01.

#### Description of The Device 5.0

Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-01 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.

Page 1 of 3

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### 7.0 Summary of Performance Data:

| TEST | ASTM D3578-01 | POWDERED LATEX EXAM.<br>GLOVES |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------|
| 1. Watertight (1000ml) | Multiple Normal<br>GI<br>AQL = 2.5 | Pass GI<br>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 ± 10<br>80 ± 10<br>95 ± 10<br>111 ± 10<br>- | 73 - 78<br>83 - 88<br>93 - 98<br>103 - 107 |
| 4. Thickness (mm)<br>(Single Layer)<br>Finger<br>Palm | Min 0.08<br>Min 0.08 | Min 0.10<br>Min 0.10 |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%)<br>Stress at 500% Elongation<br>After Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 18<br>Min 650<br>Max 5.5<br>Min 14<br>Min 500 | 26 - 30<br>820 - 940<br>2.0-3.3<br>24 - 30<br>840 - 920 |
| 6. Powder Content | 10mg per square decimetre max | Below 10 mg per square decimetre |

Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.

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510k) Summary page 3.

Test Results (Means and/or Successful Results:

This device has met or exceeded the following standards and/or tests: :

-

-

ASTM D 5712-99 ASTM D 3578-01aE2 ASTM D 5151-99 ASTM D 6124-01 ISO 2859

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

This device is substantially equivalent to the devices approved as K943807, K974191 and K023590.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald Sparkes, Nevada 89434-9550

Re: K024355

Trade/Device Name: Non-Sterile, Powdered, Natural or Colored Latex Examination Gloves, Violet & Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 23, 2002 Received: December 30, 2002

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 vour 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 vours.

Susan Kunn

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

.

:

## Applicant: YTY INDUSTRY (MANJUNG) SDN BHD

Kost 35.5 510K NUMBER:

Non-Sterile, Powdered, Natural or Colored Latex Examination Gloves Device Name: (Violet & Green Color) (Multiple Private Label)

Indication 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

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

・

Qhin S. Lin

nesthesiology. General H

510(k) Number: K 024355