EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE

K974191 · Yty Industry (Manjung) Sdn Bhd · LYY · Dec 24, 1997 · General Hospital

Device Facts

• Record ID: K974191
• Device Name: EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

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

Evergreen Non-Sterile Powdered Latex Examination Gloves are protective barriers worn by healthcare personnel. The device is a natural rubber latex glove coated with absorbable dusting powder. It functions as a physical barrier to prevent contamination between the wearer and the patient's body, fluids, waste, or environment. The gloves are used in clinical or similar settings by healthcare workers. They are manufactured to meet ASTM D3578-95 standards for dimensions, tensile strength, and elongation. The device is tested for water tightness using the FDA water leak test method (ASTM D5151-90) and evaluated for biocompatibility via primary dermal irritation and skin sensitization studies. The gloves provide a protective interface to reduce the risk of infection transmission during patient examinations.

Clinical Evidence

Bench testing only. Evidence includes physical property testing (dimensions, tensile strength, ultimate elongation) per ASTM D3578-95, water leak testing per ASTM D5151-90, and biocompatibility testing (primary dermal irritation and skin sensitization). Protein content was measured via ASTM D5712, though no label claim is made.

Technological Characteristics

Material: Natural rubber latex with absorbable dusting powder. Dimensions: 240 mm minimum length; 0.10 mm minimum thickness (palm/finger). Standards: ASTM D3578-95 (physical properties), ASTM D5151-90 (leak detection), ASTM D5712 (protein content). Non-sterile, powdered.

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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# YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P) (Company No : 00000 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Eol 1422-1424, Bula 166ing Line), 6792443 & 6792445 Fax : [phone]

APPENDIX H

DEC 2 4 1997

# 510 (K) SUMMARY

| 2 | Sumitter<br>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 Paerson 1. MR. MOH UNG NANG

Date of Summary Prepared

September 20, 1997

#### 3 Name Of Device

| Trade Name | Evergreen Non-Sterile Powdered Latex Examination Gloves |
|---------------------|---------------------------------------------------------|
| Common Name | Exam Gloves |
| Classification Name | Patient Examination Glove |

#### 4 ldentification 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 D3578-95

#### 5 Description Of The Device

Class I Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 and FDA Water Leak Test.

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#### 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.

#### 7.0 Technoligical Chracteristic of Device.

#### Dimensions A.

| DIMENSION | ASTM D 3578-95 | EVERGREEN GLOVE |
|--------------------|---------------------------------|---------------------------------|
| X Small | 70 mm +/- 10 mm | 73 - 78 mm |
| Small | 80 mm +/- 10 mm | 83 - 88 mm |
| Medium | 90 mm +/- 10 mm | 93 - 98 mm |
| Large | 100 mm +/- 10 mm | 103 - 107 mm |
| Length | 230 mm minimum<br>for all sizes | 240 mm minimum<br>for all sizes |
| Thickness – finger | 0.08 mm minimum | 0.10 mm minimum |
| Palm | 0.08 mm minimum | 0.10 mm minimum |

B.

| TEST | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------|------------------|----------|---------------------|--------|
| | ASTM | YTY'S | ASTM | YTY'S |
| | D3578-95 | Gloves | D 3578-95 | Gloves |
| BEFORE AGING | 14.0 Mpa. | 26.7 Mpa | 700% | 840% |
| AFTER AGING<br>7 days at 70 | 14.0 Mpa. | 21.8 Mpa | 500% | 820% |

Our gloves meets all the specifications of the ASTM D3578-95 Standards.

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#### C. WATER TIGHT TEST

FDA water leak test method is used to test 80 pieces of gloves at AQL 4.0% General Inspection II multiple sampling plan. The results are as follows:

| Batch | Size | Sample Size | Unit Leak | Disposition |
|----------|--------|-------------|-----------|-------------|
| 70881981 | Large | 80 | 1 | Accepted |
| 70881962 | Medium | 80 | 1 | Accepted |
| 70882003 | Small | 80 | 0 | Accepted |

The test meets the FDA Water Leak Test Requirements.

#### BIOCOMPATIBILITY ப்

The test consists of Primary Dermal Irritation Test and Skin Sensitization Study.

The gloves pass the the Biocompatibility Tests.

#### E. Water Soluble Protein Test by ASTM D5712 standards.

| Batch No. Production Date | Protein Content ug/g<br>(against OVBM) |
|-----------------------------------|----------------------------------------|
| 1. R123-5L5M<br>(03/09/97) Medium | 209 |

There is no Label Claim on Protein Level.

### Conclusion.

We concluded that Evergreen Non-Strile, Latex Examination Gloves meet:

- ASTM D3578-95 --Standard.
- -FDA Water Leak Test requirements.
- ASTM D5151 -90 Test method for Detection of Holes in Medical Gloves. -

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by three intertwined human profiles. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 2 4 1997

Mr. Leonard Frier ·President YTY Industry Sdn. Bhd. C/O MET Laboratories 914 West Patapsco Avenue Baltimore, Maryland 21230-3432

K974191 Re : Everqreen Non-Sterile Powdered Latex Trade Name: Examination Glove Requlatory Class: I Product Code: LYY December 18, 1997 Dated: Received: December 19, 1997

Dear Mr. Frier:

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, Druq, 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 reqistration, 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 regulations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Frier

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 requlations.

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 regulation (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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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## INDICATIONS FOR USE STATEMENT

Applicant : YTY INDUSTRY (MANJUNG ) SDN BHD

510K Number : Poli 22 personal program and the production of the comments of the comments of the comments of the comments of the country of the country of the country of the country of the Device Name : Evergreen Latex Examination Gloves ર

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

| 510(k) Number | K974191 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter <img alt="check" src="..."/> |
|--------------------|----|-----------------------------------------------|
| Per 21 CFR 801.109 | | |