POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)

K023577 · Yty Industry (Manjung) Sdn Bhd · LYY · Dec 6, 2002 · General Hospital

Device Facts

• Record ID: K023577
• Device Name: POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable patient examination glove; natural or colored latex; poly-coated; powder-free. Used by healthcare professionals (dentists, doctors, nurses, lab staff) in clinical settings to provide a protective barrier between examiner and patient. Prevents cross-contamination. Device is worn on hands or fingers. Performance verified against ASTM standards for watertight integrity, physical dimensions, tensile strength, and protein content (<50ug/g).

Clinical Evidence

Bench testing only. Testing included watertight (1000ml) testing, physical dimensions (length, palm width, thickness), physical properties (tensile strength, ultimate elongation, stress at 500% elongation), powder content, and protein content. Biocompatibility testing included dermal sensitization and primary skin irritation. All results met or exceeded ASTM D3578-01, ASTM D5712-99, ASTM D6124-01, and ASTM D5151-99 standards.

Technological Characteristics

Material: Natural latex with polycoating. Powder-free. Dimensions: 240mm minimum length. Standards: ASTM D3578-01aE2, ASTM D5712-99 (protein), ASTM D6124-01 (powder), ASTM D5151-99 (watertight), ISO 2859. Protein content <50ug/g. Powder content <2mg/glove.

Indications for Use

Indicated for use by healthcare professionals in dentist and doctor offices, laboratories, clinics, and hospitals as a disposable barrier to prevent cross-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.

Predicate Devices

• Supergrade Healthcare Products SDN BHD (K014134)
• Shield Gloves Manufacturer (M) (K000156)

Submission Summary (Full Text)

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

K023577

# 510(k) SUMMARY

| Submitted For: | YTY INDUSTRY (MANJUNG) SDN BHD |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for YTY INDUSTRY<br>(MANJUNG) SDN BHD<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date of Submission: | 21 October 2002 |
| Device Name: | Powder Free, Natural and/or Colored Latex Exam<br>Gloves, with Protein labeling (<50ug/g) and Polycoating<br>Class I Device, 80LYY |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals at<br>Dentist and Doctor Offices, Laboratories, Clinics and<br>Hospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand<br>or finger to prevent contamination between patient and<br>examiner. |
| Substantial Equivalence: | Both in its intended use and/or physical<br>characteristics, this device is equivalent to devices<br>currently marketed by U.S. companies. It is Substantially<br>Equilavent to the devices manufactured by Supergrade<br>Healthcare Products SDN BHD, except for color, K014134,<br>and by Shield Gloves Manufacturer (M), except for scent,<br>K000156. |

EXHIBIT Q
Page 90 of 92 (Revised 10-23-02)

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

### Summary of Performance Data:

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

| TEST | ASTM D3578-01A62 | YTY INDUSTRY POWDER FREE<br>LATEX EXAM. 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<br>- | |
| 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 | 23 - 27<br>820 - 900<br>2.9-3.8<br>22 - 26<br>780 - 860 | |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram | |

### Page 2 of 3

EXHIBIT Q
Page 91 of 92

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

510k) Summary page 2.

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 6124-01 ASTM D 5151-99 ISO 2859

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

This device is substantially equivalent to the devices approved as K014134 and K000156.

EXHIBIT Q
Page 92 of 92

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

#### 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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

Public Health Service

DEC 0 6 2002

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'emerald Sparks, Nevada 89434-9550

Re: K023577

Trade/Device Name: Powder Free, Latex Examination Gloves, Poly Coated Natural and/or Green Color, with Protein Labeling Contains 50 Micrograms Or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 21, 2002 Received: October 23, 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 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. Tücker

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]. 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 Part 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,

Ted Ullyot

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

## INDICATIONS FOR USE

K023577

## APPLICANT:

YTY INDUSTRY (MANJUNG) SDN. BHD.

#### 510(k) NUMBER:

# DEVICE NAME:

## POWDER FREE LATEX EXAM GLOVES, POLY COATED, NATURAL AND/OR GREEN COLOR, WITH SAno/o)

A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clim S. Lin

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023577

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

EXHIBIT B
page 2 of 92 (revised 12-4-02)