NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O

K991742 · Yty Industry (Manjung) Sdn Bhd · LYY · Jun 21, 1999 · General Hospital

Device Facts

• Record ID: K991742
• Device Name: NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 21, 1999
• 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, polymer-coated latex examination glove; worn on hands of healthcare personnel; acts as physical barrier to prevent cross-contamination between wearer and patient/patient environment; manufactured by YTY Industry (Manjung) Sdn. Bhd.; distributed under Evergreen and private labels.

Clinical Evidence

Bench testing only. Performance data includes watertight (1000ml) testing per ASTM D3578-95, physical property testing (tensile strength, elongation before/after aging), powder residual content (<2 mg/glove), and water-extractable protein content (≤ 50 µg/g). Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests.

Technological Characteristics

Latex examination glove; polymer-coated; powder-free; meets ASTM D3578-95 standards; dimensions: 240mm minimum length; thickness: 0.10mm (finger/palm); protein content ≤ 50 µg/g; powder content < 2 mg/glove.

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.

Submission Summary (Full Text)

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# (TY INDUSTRY (MANJUNG) SDN. BHD.

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

- JUN 2 1 1999
K991742

PENDTX .J

| 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 |
| | Date of Summary Prepared | April 27, 1999 |
| 3.0 | Name of Device | |

| Trade Name : | Non-Sterile Powder Free Polymer Coated Latex Examination Glove |
|--------------|----------------------------------------------------------------|
| | (Evergreen & Multiple Private Labels) |

- Common Name Exam Glove
Classification Name Patient Examination Glove

#### 4.0 Identification of The Legally Marketed Devices

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.

#### 5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.

#### 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.

Page 1 of 3

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K991742

### 7.0 Summary of Performance Data:

Performance data of gloves based on ASTM D3578-95 and FDA 1000ML watertight test.

| TEST | ASTM D3578-95 | EVERGREEN POWDER FREE<br>LATEX EXAM. GLOVES |
|------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------|
| 1. Watertight (1000ml) | GII<br>AQL = 4.0% | Pass GII<br>AQL = 4.0% |
| 2. Length (mm)<br>Size<br>XS<br>S<br>M<br>L<br>XL | Min 230<br>Min 230<br>Min 230<br>Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm)<br>Size<br>XS<br>S<br>M<br>L<br>XL | -<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>After Aging | Min 14<br>Min 700 | 23 - 27<br>830 - 870 |
| Tensile Strength (Mpa)<br>Ultimate Elongation (%) | Min 14<br>Min 500 | 23 - 26<br>820 - 850 |
| 6. Powder Content | - | Below 2 mg/glove |
| 7. Protein Content | - | Below 50 microgram/gram |

:

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K991742

- The performance data of the glove as shown above meet the ASTM D3578-95 Standard 8.0 and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is ≤ 50 mg/gram.
- 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, Powder Free Polymer Coated Latex Examination Gloves meet:

- ASTM D3578-95 Standard -
- FDA pinhole requirements -
- FDA minimum Powder Residual Content. -
- Label Claim of maximum 50 micrograms per gram of glove or less for water -Extractable Protein.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wavy lines representing wings or snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

YTY Industry (Manjung) Sdn. Bhd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 21114 Crofton, Maryland

K991742 Re : Non-Sterile, Powder Free, Polymer Coated Trade Name: Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY May 10, 1999 Dated: Received: May 21, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Smith

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991742

## INDICATIONS FOR USE STATEMENT

Applicant: YTY INDUSTRY (MANJUNG) SDN BHD

510K Number:

with Protein Content labeling Claim of 50 microgram or le Device Name: Non-Sterile Powder Free Polymer Coated Latex Examination Glove SA Evergreen & Multiple Private Labeled)

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.

> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ...................... Per 21 CFR 801.109

Over-The-Counter ...

Qlin S. tim

OR

510(k) Num