NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES

K061553 · Yty Industry (Manjung) Sdn Bhd · LZA · Jul 17, 2006 · General Hospital

Device Facts

• Record ID: K061553
• Device Name: NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jul 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This Non-Sterile, Powder-Free, Black Nitrile 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.

Device Story

Disposable black nitrile examination glove; worn on hands/fingers by healthcare providers during patient examinations. Acts as physical barrier to prevent cross-contamination between patient and examiner. Manufactured from nitrile rubber; powder-free. Tested for watertight integrity, tensile strength, and elongation per ASTM D6319-00a standards. Biocompatibility confirmed via primary dermal irritation and sensitization testing. Used in clinical settings; non-sterile.

Clinical Evidence

Bench testing only. Performance data includes watertight (1000ml) testing (AQL 2.5), physical dimensions, tensile strength (15-21 MPa before aging), ultimate elongation (550-630% before aging), and residual powder content (<2 mg/glove). Biocompatibility testing included primary dermal irritation and Guinea Pig sensitization (Buehler) tests. All results met ASTM D6319-00a and FDA requirements.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable, powder-free, black examination glove. Standards: ASTM D6319-00a. Physical properties: Min 0.08mm thickness (finger/palm). Biocompatibility: Passed primary dermal irritation and sensitization tests. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical examiners to prevent cross-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.

Predicate Devices

• KOST 50Z

Submission Summary (Full Text)

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K061553

and the comments of the comments of the comments of

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:

JUL 1 7 2006

### Appendix J 510(k) Summary Sheet

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:

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| Description and Intended Use of the Gloves........................ | Appendix J, Page 1 |
|-----------------------------------------------------------------------------------------------------------------------|--------------------|
| Product Comparison Chart against ASTM D6319-00ae3<br>and FDA 1000ML Watertight test Standards........................ | Appendix J, Page 2 |

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Image /page/1/Picture/0 description: The image shows a black and white drawing of a symbol. The symbol is composed of a horizontal curved line at the top, resembling a crescent. Below the curved line, there are two vertical rectangular shapes, with smaller horizontal rectangular shapes on either side of the top rectangular shape. The symbol appears to be abstract and stylized.

# 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 & 6792445 Fax : [phone]

### 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 | May 2, 2006 | |
| 3.0 | Name of Device | | |
| | Trade Name: | Non-Sterile, Powder-Free, Black Nitrile Examination Gloves. | |
| | Common Name: | Synthetic Rubber Examination Gloves | |

Classification Name: Patient Examination Glove, Powder Free

#### 4.0 Identification of The Legally Marketed Devices

Black Colour Powder Free Nitirle Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880,6250). It meets all the current specifications listed under the ASTM Specification D6319-00at Standard Specification for Nitrile Gloves for Medical Application.
EQui VALENT TO KOST 50Z EXCEPT FOR COLOR.

#### 5.0 Description of The Device

.

Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.

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#### 6.0 The Intended Use of Glove

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

#### 7.0 Summary of Performance Data:

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

| TEST | ASTM D6319-00a $⁳$ | POWDER FREE NITRILE EXAMINATION GLOVES |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------|
| 1. Watertight (1000ml) | Multiple Normal<br>GII<br>AQL = 2.5 | Pass GII<br>AQL = 2.5 |
| 2. Length (mm)<br>Size 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 XS<br>S<br>M<br>L<br>XL | $70 \pm 10$<br>$80 \pm 10$<br>$95 \pm 10$<br>$111 \pm 10$<br>- | 73 - 78<br>83 - 88<br>93 - 98<br>103 - 107 |
| 4. Thickness (mm)<br>(Single Layer)<br><br>Finger<br>Palm | Min 0.05<br>Min 0.05 | Min 0.08<br>Min 0.08 |
| 5. Physical Properties<br><br>Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%)<br><br>After Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 500<br><br>Min 14<br>Min 400 | 15 - 21<br>550 - 630<br><br>14 - 22<br>520 - 610 |
| 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 D6319-00a E-3 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- 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 conclude that the Multiple Private Labeled Non-Sterile Black Colour Powder Free Nitirle Examination Gloves meets:

- -ASTM D6319-00a Standard
- -FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00aE3

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, representing the department's focus on health and well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2006

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: K061553

Trade/Device Name: Non-Sterile, Powder-Free, Black Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 1, 2006 Received: June 7, 2006

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 (OS) 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,

Sutta Y. Michaud

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

Enclosure

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# INDICATIONS FOR USE

| APPLICANT: | YTY INDUSTRY (MANJUNG) SDN.<br>BHD. |
|----------------|--------------------------------------------------------------|
| 510(k) NUMBER: | |
| DEVICE NAME: | NON-STERILE, POWDER-FREE, BLACK NITRILE<br>EXAMINATION GLOVE |

## Indications For Use:

This Non-Sterile, Powder-Free, Black Nitrile 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.

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

AND/OR

Over-The-Counter Use ... X .......... (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 K. Mupadhyay, M.D. 2/14/04

n of Anesthesiology, General Hospital, on Control, Dental Devices

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