POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

K062955 · Pt. Haloni Jane · LYY · Nov 9, 2006 · General Hospital

Device Facts

• Record ID: K062955
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
• Applicant: Pt. Haloni Jane
• Product Code: LYY · General Hospital
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder free Latex Examination gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable latex examination gloves; worn on examiner's hands; intended to prevent cross-contamination between patient and examiner during medical procedures. Device serves as a physical barrier. Used in clinical settings by healthcare professionals. Benefits include reduction of infection transmission risk.

Clinical Evidence

No clinical data. Bench testing only; device meets ASTM D 3578-05ae2 standards for tensile strength, elongation, and FDA pinhole requirements.

Technological Characteristics

Material: Latex. Dimensions: 240mm length (min), 0.1mm thickness (min) at cuff, palm, and finger. Physical properties: 14 MPa tensile strength (min), 500% ultimate elongation (min) before aging. Meets ASTM D 3578-05ae2.

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

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

Submission Summary (Full Text)

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# PT. Haloni Jane

10,2

Jalan Raya Serang Km. 13,8 Cikupa – Tangerang Indonesia Ph. ([phone] Fax [phone] Email [e-mail]

### "510 (K)" SUMMARY

| (1) Name of applicant<br>Address | : ANDY TANAKA<br>: PT. Haloni Jane<br>Jl. Raya Serang Km. 13.8<br>Cikupa - Tangerang<br>Indonesia<br>Phone No. : 62-61-5962435<br>Fax No. : 62-61-5962436 | NOV - 9 2006 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact person in U.S.A | : Emmy Tjoeng<br>Phone No. : 909-591-8855<br>Fax No. : 909-628-6283 | |
| (2) Device details<br>Trade Name<br>Classification Name | : Powder free Latex Examination Gloves<br>: Powder free Latex Examination Gloves | |
| (3) Product Code | : 80 LYY | |
| (4) Equivalent device legally<br>marketed | : Class I Examination Gloves 80 LYY, Powder Free<br>meeting ASTM D 3578-05ae2 | |
| (5) Intended use | : Powder free Latex Examination gloves is a disposable device<br>intended for medical purpose that is worn on examiner's hand to<br>prevent contamination between patient and examiner. | |

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## PT. Haloni Jane

KOG2955

222

Jalan Raya Serang Km. 13,8 Cikupa – Tangerang Indonesia Ph. ([phone] Fax [phone] Email [e-mail]

| (6) Technological characteristic of the gloves. | | | | |
|-------------------------------------------------|-------|----------------|-------|----------------------------------|
| a. Dimensions<br>Sizes | Small | Medium | Large | X-Large |
| Length mm (min.) | 240 | 240 | 240 | 240 $\pm$ 5 |
| Palm Width mm | 80 | 95 | 105 | 110 $\pm$ 10 |
| Thickness | | | | |
| 1. Cuff mm (min) | 0.1 | 0.1 | 0.1 | 0.1 |
| 2. Palm mm(min) | 0.1 | 0.1 | 0.1 | 0.1 |
| 3. Finger Tip mm | 0.1 | 0.1 | 0.1 | 0.1 |
| b. Physical Properties | | | | |
| | | Before ageing | | After ageing<br>at 70°C 168 hrs. |
| Tensile Strength | | : 14 Mpa (min) | | 14 Mpa (min) |
| Ultimate Elongation | | : 500 % (min.) | | 400 % (min.) |

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

(8) Clinical data is not needed for gloves or for most devices cleared by the 510 (K) process.

#### (9) Non-clinical data

We certify that our final finished powder free latex examination 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

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV ~ 9 2006

PT. Haloni Jane C/O Ms. Emmy Tjoeng Marketing Director Shamrock Marketing Company, Incorporated 5445 Daniels Street Chino, California 91710

Re: K062955

Trade/Device Name: Powder Free Latex Examination Gloves, Small, Medium, Large Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 26, 2006 Received: October 31, 2006

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 vour 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,

Auy Sullom bor
Ching-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

Enclosure

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#### ANNEXURE II

## INDICATION FOR USE

| Applicant | : PT. Haloni Jane |
|--------------------------|----------------------------------------|
| 510(k) Number (if known) | : K062955 |
| Device Name | : Powder Free Latex Examination Gloves |
| Indication for use | : |

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR 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 A. Mighley 12

f Anesthesiology, General Hospital,
ion Control, Dental Devices

Number K062953