YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P)
Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, M a l a y 5 l F E ~ 0 3 2003
Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188

APPENDIX I

1.o 510 (K) SUMMARY

2.0 Submitter YTY industry (Manjung) Sdn Bhd

Lot 1422-1424, Batu 10 Lekir
32020 Sitiawan
Perak Darul Ridzuan
MALAYSIA

Te I 605-6792288

Fax 605-679 1 188

Name of Contact Person 1. MR. MOH UNG NANG

Ofticia1 Correspondence 1 . JANNA TUCKER

Date of' Summary Prepared Novembcr 30, 2002

3.0 Name of Device

Trade Name Non-Sterile Powdered Natural or Colored Latex Examination

Gloves (Multiple Private Labels)
Coinrnon Name Exam Glove
CI assi ficat ion-Name Patient Examination Glove

4.0 Identification of The Legally Marketed Devices

Class 1 Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting
powder, that meets all of the requirements of ASTM Standard D3578-01.

5.0 Description of The Device

Class 1 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
7.0 Summary of Performance Data:

Perforinance data ofgloves based on ASTM D3578-01 and FDA IOOOML watertight test.

TEST ASTM D3578-01 POWDERED LATEX EXAM.

GLOVES
Multiple Normal
1 Watertight (1000ml) GI AQL = 2.5 Pass GI AQL = 2.5

2. Length (mm)
Size XS Min 220 240 rnm minimum for all sizes
S Min 220
M Min 230
1. Min 230
XL

3 . Palm width (mm)

Size XS 7 0 L 10 73 78
~

S 8 0 + 10 83 - 88
M 95+ IO 93 98
~

L 111~10 103 107

~

sL

4. Thickness (nim)
(Single Layer)

Finger Min 0.08 Min 0.10

Palm Min 0.08 Min 0.10

5. Physical Properties

Before Aging
Tensile Strength (MPa) Min 18 26 30
~

Ultimate Elongation (“YO) Min 650 820 - 940

Stress at 500% Elongation Max 5.5 2.0-3.3

After Aging
Tensile Strength (MPa) Min 14 24 - 30
Ultimate Elongation (YO) Min 500 840 - 920

6. Powder Content lOmg per square decimetre max Below 10 mg per square decimetre

Page 2 of 3
5 1Ok) 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 3578-01am
ASTM D 5151-99
ASTM D 6124-01
I S 0 2859

Bio-Compatibility :
Dermal Sensitization
Primary Skin Irritation

Conclusion: This device is substantially equivalent to the devices

approved as K943807, K974191 and K023590.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

~-

Food (and Drug Administration

9200 Corporate Boulevard
Rockville MD ;!0850
FES 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: KO24355
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 5 1O(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 mark.eted 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 preinarket
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 I1 (Special Controls) or class I11
(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 2 1, Parts 800 to 8'38. In
addition, FDA may publish further announcements concerning your device in the Federal
Register.
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 practjce
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if
applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act);
21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 1O(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 IrOl),
please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation
entitled, "Misbranding by reference to premarket notification" (2 1CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address
http ://www.fda.gov/cdrh/dsmddsmamain. html

Sincerely yours,
f 7

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
I rid icx t ioii f:o I’ I ‘<e:

..................................................................................................................................
Coiiciii-i-ciicc o f C ‘ D R I I O f l i c e o f Device Evaluatioil ( O D E )

1’1-esri - i p t iori Use ............. 0 I< O v e r--Tlie-Co11 t i t e r. ..................

Per 2 1 CI’R 801.lOO

(Division Sign-off) 2
Division of Anesthesiology, General Hospital,
Infection Control. Dental Devices
510(k)Number k. -wsf