NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED

K974518 · Yty Industry (Manjung) Sdn Bhd · LYY · Dec 12, 1997 · General Hospital

Device Facts

• Record ID: K974518
• Device Name: NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 12, 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

Non-sterile, powder-free latex examination gloves; available in natural, pink, and blue colors. Worn by healthcare personnel to provide a protective barrier against patient body fluids, waste, and environmental contaminants. Device functions as a physical barrier; manufactured from natural rubber latex. Used in clinical settings to reduce cross-contamination risk. Performance verified through watertight testing, physical property assessment (tensile strength, elongation), and biocompatibility testing (dermal irritation and sensitization).

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000ml), physical properties (tensile strength 26.5 MPa before aging, 22.3 MPa after aging; ultimate elongation 810% before aging, 750% after aging), powder content (<2 mg/glove), and protein content (<50 µg/g). Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buchler) tests, which the device passed.

Technological Characteristics

Material: Natural rubber latex. Form factor: Powder-free examination glove. Dimensions: 240 mm minimum length; varying palm widths. Standards: Meets ASTM D3578-95. Physical properties: Tensile strength >14 MPa (before/after aging); elongation >700% (before) and >500% (after). Powder content: <2 mg/glove. Protein content: <50 µg/g. Sterilization: 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.

Submission Summary (Full Text)

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K974518
December 12, 1998

# YTY INDUSTRY (MANJUNG) SDN. BHD.

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

## 510 (K) SUMMARY

### 2.0 Submitter

YTY Industry (Manjung) Sdn Bhd
Lot 1422-1424, Batu 10 Lekir,
32020 Sitiawan,
Perak Darul Ridzuan,
MALAYSIA.

Tel [phone]
Fax [phone]
Name of Contact Person 1. MR MOH UNG NANG
Date of Summary Prepared September 25,1997

### 3.0 Name Of Device

Trade Name : Evergreen Non-Sterile Powder Free Latex Examination Glove -Natural Color
Evergreen Non-Sterile Powder Free Latex Examination Glove -Pink
Evergreen Non-Sterile Powder Free Latex Examination Glove -Blue

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, powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA requirements.

### 5.0 Description Of The Device

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

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# 7. Summary of Performance Data :

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

| TEST | ASTM D3578-95 | EVERGREEN POWDER FREE LATEX EXAMINATION GLOVES |
| --- | --- | --- |
| 1. Watertight (1000ml) | G II AQL=4.0% | Pass G II AQL= 4.0 % |
| 2. Length (mm) | | |
| Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | - | |
| 3. Palm width (mm) | | |
| Size XS | - | 73 - 78 |
| S | 80 +- 10 | 83 - 88 |
| M | 95 +- 10 | 93 -98 |
| L | 111 +- 10 | 103 - 107 |
| XL | | |
| 4. Thickness (mm) (Single Layer) | | |
| Finger | min 0.08 | 0.10 minimum |
| Palm | min 0.08 | 0.10 minimum |
| 5. Physical Properties. | | |
| Before Ageing | | |
| Tensile Strength (Mpa) | min 14 | 26.5 |
| Ultimate Elongation (%) | min 700 | 810 |
| After Ageing | | |
| Tensile Strength (Mpa) | min 14 | 22.3 |
| Ultimate Elongation (%) | min 500 | 750 |
| 6. Powder Content | - | below 2 mg / glove |
| 7. Protein Content | - | below 50 microgram / gram |

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8. The performance data of the glove as shown above meet the ASTM D3578-95 Standard 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 &lt; 50mg/gram.

9. The Biocompatibility Tests consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test.
The gloves pass the Biocompatibility Tests.

10. Conclusion

We concluded that the Evergreen non-sterile, powder-free Latex Examination Gloves meet:

- ASTM D3578-95 Standard
- FDA pinhole requirements
- FDA minimum powder residual content.

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

YTY Industry (Manjung) SDN. BHD.
G/O Leonard Frier, PE
President
Met Laboratories
914 West Patapsco Avenue
Baltimore, Maryland 21230-3432

Re: K974518
Trade Name: Non-Sterile Powder-Free Latex Examination
Gloves Colored
Regulatory Class: I
Product Code: LYY
Dated: November 26, 1997
Received: December 2, 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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Frier

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 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.gov/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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Attachment 1b
Page ____ of ____

510(k) Number (if known): ___________________________

Device Name: **Evergreen Latex Powder-Free Examination** Gloves; Natural, Pink, Blue

Indications For Use:

This is a medical glove worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number **K974518**

cription Use ☐
21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)