NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES

K052502 · Yty Industry (Manjung) Sdn Bhd · LZA · Nov 18, 2005 · General Hospital

Device Facts

• Record ID: K052502
• Device Name: NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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, ware or environment.

Device Story

Disposable nitrile examination glove; blue or white color; powder-free. Worn by healthcare personnel on hands/fingers during patient examinations. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Performance verified via watertight testing and physical property analysis (tensile strength, elongation) per ASTM D6319-00a83 standards.

Clinical Evidence

No clinical data. Evidence consists of bench testing including watertight (1000ml) testing, physical property testing (tensile strength and ultimate elongation before and after aging), and powder content analysis, all meeting ASTM D6319-00a83 standards. Biocompatibility testing (primary dermal irritation and Guinea Pig Sensitization) was performed.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile. Dimensions: 240mm minimum length; palm width 73-107mm depending on size. Thickness: min 0.15mm (finger), 0.12mm (palm). Physical properties: Tensile strength 25-30 MPa, elongation 670-800%. Meets ASTM D6319-00a83 and FDA 1000ml watertight test requirements.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent 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.

Submission Summary (Full Text)

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INDUSTRY (MANJUNG) SDN. BHD.

ompany No : 380830-P) ot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia.
Ot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Lot 1422-1424, Bata 10 Lokii, Cel 6792443 & 6792445 - Fax : [phone]

| NOV | 1 8 2005 |
|-----|----------|
|-----|----------|

APPENDIX-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 |
| Official Correspondence | 2. MS. JANNA TUCKER |
| Date of Summary Prepared | July 20, 2005 |

#### 3.0 Name of Device

Trade Name: NON-STERILE, ON-LINE POWDER-FREE, NITRILE BLUE & WHITE COLOR, EXAMINATION GLOVES

| Common Name | Exam Glove |
|-------------|------------|
|-------------|------------|

Classification Name Patient Examination Glove

## 4.0 Identification of The Legally Marketed Devices

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a63 and FDA requirements.

## 5.0 Description of The Device

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 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, ware or environment.

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## Summary of Performance Data: 7.0

Performance data of gloves based on ASTM D6319-00a8 and FDA 1000ML watertight test.

| TEST | ASTM D6319-00a3 | ON-LINE POWDER FREE<br>NITRILE EXAM. GLOVES | |
|-------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------|----------------------|
| 1. Watertight (1000ml) | Multiple Normal<br>GI <span style="float:right">AQL = 2.5</span> | Pass GI | 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 | |
| 4. Thickness (mm)<br>(Single Layer) | | | |
| Finger<br>Palm | Min 0.05<br>Min 0.05 | Min 0.15<br>Min 0.12 | |
| 5. Physical Properties | | | |
| Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 500 | | 27 - 30<br>780 - 800 |
| After Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 400 | | 25 - 27<br>670 - 730 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |

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- 8.0 The performance data of the glove as shown above meet the ASTM D6319-00a83 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion

We concluded that the Multiple Private Labeled Non-Sterile, On-Line Powder Free Nitrile Blue & White Color Examination Gloves meets:

- ASTM D6319-00a63Standard -
- FDA pinhole requirements -
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a83

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# Appendix J 510(k) Summary Sheet

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| Description and Intended Use of the Gloves........................ | Appendix J, Page 1 |
|---------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product Comparison Chart against ASTM D6319-<br>00aε3 and FDA 1000ML Watertight test<br>Standards........................ | Appendix J, Page 2 |

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2005

YTY Industry (Manjung) SDN.BHD. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550

Re: K052502

Trade/Device Name: Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 10, 2005 Received: November 14, 2005

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.

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Page 2 - Ms. Tucker

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]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Auey Suleom for
Chin-Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATIONS FOR USE

**APPLICANT:** YTY INDUSTRY (MANJUNG)
SDN. BHD.

**510(k) NUMBER:** R052502

**DEVICE NAME:** NON-STERILE, POWDER-FREE NITRILE
BLUE & WHITE EXAMINATION GLOVES

## Indications For Use:

The Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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.

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

AND/OR

Over-The-Counter Use ... ... ... .......... (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy, KS

on Sign-On)
of Anesthesiology, General Hospital, on Control, Dental Devices

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