POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

K081488 · Pt. Maja Agung Latexindo · LYY · Aug 28, 2008 · General Hospital

Device Facts

• Record ID: K081488
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
• Applicant: Pt. Maja Agung Latexindo
• Product Code: LYY · General Hospital
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A powder-free 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.

Device Story

Powder-free latex examination gloves; disposable; worn on examiner's hand or finger. Used in clinical settings to provide a barrier preventing contamination between patient and examiner. Manufactured from latex; meets ASTM D 3578-05ae2 standards for physical properties and pinhole requirements. No electronic or software components.

Clinical Evidence

No clinical data.

Technological Characteristics

Latex material; powder-free. Dimensions: 240mm length; palm width 80-110mm; thickness 0.08-0.10mm. Physical properties: Tensile strength 18 MPa (min) before aging, 14 MPa (min) after aging; ultimate elongation 650% (min) before aging, 500% (min) after aging. Meets ASTM D 3578-05ae2 standards.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

• Class I Examination Gloves 80 LYY (meeting ASTM D 3578-05ae2)

Submission Summary (Full Text)

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JUFACTURE OF LATEX GLOVES

Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

AUG 2 8 2008

Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

Page Numbers 1 of 2

"510 (K)" SUMMARY

K081488

| (1) Name of applicant | |
|-----------------------|--|
| Address | |

: SIVA PRAKASH, General Manager : PT. Maja Agung Latexindo J1. Utama No. 08, Puji Mulio, Sunggal 20352 North Sumatera - Indonesia Phone No. : 62-61-8459170 Fax No. : 62-61-8459180

Contact person in U.S.A

: Emmy Tjoeng : 909-591-8855 Phone No. : 909-628-6283 Fax No. : [e-mail] Email

| (2) Device details | |
|---------------------|---------------------------------------|
| Trade Name | : Powderfree Latex Examination Gloves |
| Classification Name | : Powderfree Latex Examination Gloves |

: 80 LYY (3) Product Code

- (4) Equivalent device legally : Class I Examination Gloves 80 LYY marketed meeting ASTM D 3578-05ae2
: A powder-free patient examination glove is a disposable device (5) Intended use intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG Sumatera Utara - Indonesia

Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

Page Numbers 2 of 2

# (6) Technological characteristic of the gloves.

| a. Dimensions<br>Sizes | Small | Medium | Large | X-Large | |
|------------------------|-------|----------------|-------|----------------------------------|------|
| Length mm (min.) | 240 | 240 | 240 | 240 | ± 5 |
| PalmWidth mm | 80 | 95 | 105 | 110 | ± 10 |
| Thickness (min) | | | | | |
| 1. Cuff mm | 0.08 | 0.08 | 0.08 | 0.08 | |
| 2. Palm mm | 0.10 | 0.10 | 0.10 | 0.10 | |
| 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.10 | |
| b. Physical Properties | | | | | |
| | | Before ageing | | After ageing<br>at 70°C 168 hrs. | |
| Tensile Strength | | : 18 Mpa (min) | | 14 Mpa (min) | |
| Ultimate Elongation | | : 650 % (min.) | | 500 % (min.) | |

(7) Performance data is the same as mentioned immediately above.

- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (9) Non-clinical data We certify that our gloves meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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### Public Health Service

# AUG 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PT. Maja Agung Latexindo C/O Ms. Emmy Tjoeng Marketing Director Shamrock Manufacturing Company Incorporated 5445 Daniels Street Chino, California 91710

Re: K081488

Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 15, 2008 Received: August 22, 2008

Dear Ms. Tjoeng:

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. Tjoeng

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Chien-Lung, 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

Enclosure

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# PT. MAJA AGUNG LATEXINDO

MANUFACTURING OF LATEX GLOVES

Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

- . «

## ANNEXURE II

# INDICATION FOR USE

| Applicant | : PT. Maja Agung Latexindo |
|--------------------------|----------------------------------------|
| 510(k) Number (if known) | : |
| Device Name | : Powder Free Latex Examination Gloves |
| Indication for use | : |

A powder-free 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.

Prescription Use (Part 21 CFR 801 Subpart D)

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)<br>(Division Sign-Off) | |
|-----------------------------------------------------------------------------------|---------|
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K081488 |