EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK

K983608 · Yty Industry (Manjung) Sdn Bhd · LYY · Nov 5, 1998 · General Hospital

Device Facts

• Record ID: K983608
• Device Name: EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Nov 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical gloves 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 Powder Free Latex Examination Glove; disposable latex glove; available in natural, pink, and blue colors. Worn by healthcare personnel in clinical settings to provide barrier protection against patient body fluids, waste, and environmental contaminants. Device functions as a physical barrier; prevents cross-contamination between examiner and patient. Manufactured to meet ASTM D3578-95 standards for watertight integrity, dimensions, and physical properties. Tested for biocompatibility via primary dermal irritation and guinea pig sensitization. Provides low protein content (≤ 50 micrograms/gram) and low powder residue (< 2 mg/glove).

Clinical Evidence

Bench testing only. Performance data includes watertight (1000ml) testing per FDA requirements, physical dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before/after aging) per ASTM D3578-95. Biocompatibility testing included primary dermal irritation and Guinea Pig Sensitization (Buchler) tests. Protein content verified at < 50 micrograms/gram and powder content < 2 mg/glove.

Technological Characteristics

Latex material; powder-free; non-sterile. Dimensions and physical properties comply with ASTM D3578-95. Watertight integrity verified via 1000ml test. Biocompatibility confirmed via dermal irritation and sensitization testing. Protein content ≤ 50 micrograms/gram; powder residue < 2 mg/glove.

Indications for Use

Indicated for use as a disposable medical device worn on the hands of healthcare personnel to prevent contamination between the patient and the 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.

Submission Summary (Full Text)

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K98 3608

Image /page/0/Picture/2 description: The image shows a black and white drawing of an object that appears to be a stylized representation of a stool or altar. It has a rectangular base with three vertical supports, and a crescent-shaped object rests on top of the supports. The overall design is simple and symmetrical, with a focus on geometric shapes.

## YTY INDUSTRY (MANJUNG) SDN. BHD.

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

## ATTACHMENT N

### SMDA 510 (K) SUMMARY 1.0 YTY Industry Sdn Bhd 2.0 Submitter Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan Perak Darul Ridzuan MALAYSIA 605-6792288 Tel [phone] Fax 1. MR. MOH UNG NANG Name of Contact Person September 25, 1998 Date of Summary Prepared 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 Exam Glove Common Name Patient Examination Glove Classification Name Identification of The Legally Marketed Devices 4.0 Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.

ﺎ

### Description of The Device 5.0

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 gloves 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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K983608

## 7. 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 EXAMINATION GLOVES | |
|------------------------------------------|-------------------|-------------|---------------------------------------------------|----------|
| 1. Watertight (1000ml) | G II | | Pass G II | AQL=4.0% |
| 2. Length (mm) | | | | |
| Size | XS | Min 230 | 240 mm minimum for<br>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. Thicknes (mm)<br>(Single Layer) | | | | |
| Finger | | min 0.08 | 0.10 minimum | |
| Palm | | min 0.08 | 0.10 minimum | |
| 5. Physical Properties.<br>Before Ageing | | | | |
| Tensile Strength (Mpa) | | | 23.8-25.2 | |
| Ultimete Elongation (%) | min 14<br>min 700 | | 810-910 | |
| After Ageing | | | | |
| Tensile Strength (Mpa) | | | 19.8-20.7 | |
| Ultimete Elongation (%) | min 14<br>min 500 | | 750-870 | |
| 6. Powder Content | - | | below 2 mg/ glove | |
| 7. Protein content | - | | below 50 microgram/ gram | |

ATTACHMENT N Page 2 Of 3

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

K483608

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

We concluded that the Evergreen non-sterile, powder-free Latex Examination Gloves 111221 :

- a ASTM D3578-95 Standard
- -FDA pinhole requirements
- FDA minimum powder residul content. -
- Label Claim of maximum 50 micrograms per gram of glove or less for water -Extractable Protein.

Attachment N

3/3

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

5 1998 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K983608 Trade Name: Evergreen Non-sterile, Latex Powder-Free Glove with Protein Content Labeling Claim (50 Micrograms or Less) (Pink, Blue and Natural) Requlatory Class: I Product Code: LYY September 25, 1998 Dated: October 14, 1998 Received:

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. ਰ 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 Please note: this response to your the Federal Register. premarket notification 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.

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Page 2 - Mr. Smith

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,

Susan Runner

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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# 510(k) Number (if known): Қ 98 3608

Evergreen Non-Sterile, Powder-Free, Protein Content Labeling Claim(50m/crcgrom Device Name: Examination Gloves: Natural, Blue and Pink or lešs LATEX

## Indications for Use:

A patient examination glove is a disposable device intended for medical purposes, that is worn on A patient cxammation grove is a crevent contamination between patient and examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use or Prescription Use

Qiin S. Lin
(Division Sign-Off)

(Concision of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Int 510(k) Number

u(k) Number K983608