POWDER FREE LATEX EXAMINATION GLOVES, BLACK

K062709 · Pt. Maja Agung Latexindo · LYY · Dec 6, 2006 · General Hospital

Device Facts

• Record ID: K062709
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, BLACK
• Applicant: Pt. Maja Agung Latexindo
• Product Code: LYY · General Hospital
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder free Latex Examination gloves, Black, 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 glove; black color; worn on examiner's hand. Functions as physical barrier to prevent cross-contamination between patient and healthcare provider. Used in clinical settings. Device provides protection during medical examinations. No electronic or mechanical components.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing confirming compliance with ASTM D 3578-05ae2 standards for physical properties and pinhole requirements.

Technological Characteristics

Material: Latex. Dimensions: Length 240mm; Palm width 80-110mm; Thickness 0.08-0.13mm. Physical properties: Tensile strength 18 MPa (before aging), 14 MPa (after aging). Standards: ASTM D 3578-05ae2. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand 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.

Predicate Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letters "Ma" in a stylized, handwritten font. The letters are overlapping and appear to be in black. The background consists of horizontal lines, also in black, which create a striped effect. The letter "L" is on the left side of the image.

## PT. MAJA AGUNG LATEXINDO

Manufacturer of Latex Gloves Jl. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang Sumatera Utara - Indonesia
Phone : +62-61 - 8459170 (Hunting) Fax : +62-61 - 8459180 E-mail : [e-mail]

Image /page/0/Picture/3 description: The image is a black and white logo for TUV CERT. The logo is inside of a rectangle with rounded corners. The text "DIN EN ISO 9002 : 1994 Certificate 01 100 009148" is at the bottom of the logo.

JEC - 6 2006

### "510 (K)" SUMMARY K062709

| (1) Name of applicant | : SUPINAH |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | : PT. Maja Agung Latexindo<br>Jl. Utama No. 98, Puji Mulyo<br>Sunggal 20352<br>North Sumatra - Indonesia |
| Phone No. | : 62-61-8459170 |
| Fax No. | : 62-61-8459180 |
| Contact person in U.S.A | : Emmy Tjoeng |
| Phone No. | : 909-591-8855 |
| Fax No. | : 909-628-6283 |
| (2) Device details | |
| Trade Name | : Powder free Latex Examination Gloves, BLACK |
| Classification Name | : Powder free Latex Examination Gloves, BLACK |
| (3) Product Code | : 80 LYY |
| (4) Equivalent device legally marketed | : Class I Examination Gloves 80 LYY, Powder Free meeting ASTM D 3578-05ae2 |
| (5) Intended use | : Powder free Latex Examination gloves, Black, is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. |

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Image /page/1/Picture/0 description: The image shows a black and white graphic with a handwritten-style "Ma" in bold black ink. The background consists of horizontal lines, also in black, that run across the image behind the letters. The left side of the image has a thick black vertical bar, creating a framed effect around the letters and lines.

# FUNG LA

Sunggal 20352 Deli Serdang nting) Fax : +62-61 - 8459180

Image /page/1/Picture/3 description: The image is a logo for "TUV CERT" with the text "DIN EN ISO 9002: 1994 Certificate 01 100 009145" below it. The logo is enclosed in a rectangular border with rounded corners. The "TUV CERT" text is arranged in a stacked format, with "TUV" on top and "CERT" below it. There are two curved lines above and below the "TUV CERT" text.

500 % (min.)

- (6) Technological characteristic of the gloves.

| a. | Dimensions<br>Sizes | Small | Medium | Large | X-Large | |
|----|------------------------|-------|---------------|-------|----------------------------------|------|
| | Length mm (min.) | 240 | 240 | 240 | 240 | ± 5 |
| | Palm Width mm | 80 | 95 | 105 | 110 | ± 10 |
| | Thickness | | | | | |
| | 1. Cuff mm (min) | 0.08 | 0.08 | 0.08 | 0.08 | |
| | 2. Palm mm(min) | 0.10 | 0.10 | 0.10 | 0.10 | |
| | 3. Finger Tip mm | 0.13 | 0.13 | 0.13 | 0.13 | |
| | b. Physical Properties | | | | | |
| | | | Before ageing | | After ageing<br>at 70°C 168 hrs. | |
| | Tensile Strength | | 18 Mpa (min) | | 14 Mpa (min) | |

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

Ultimate Elongation

(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, black, meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using black ink on a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2006

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

Re: K062709

Trade/Device Name: Powder Free Latex Examination Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 8, 2006 Received: November 13, 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 cither 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 mount that I Drimal statutes and regulations administered by other Federal agencies. or the For of any / vith 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 alle fishing (21 cm rail 001), and 0017, systems (QS) regulation (21 CFR Part 820); and if requirements as 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) rms reter 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), 11 you dontact the Office of Compliance at [phone]. Also, please note the regulation i 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,

Suigte Y. Michael MD,

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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Image /page/4/Picture/0 description: The image shows a logo with the letters "Ma" in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background behind the letters consists of horizontal lines, creating a striped effect. The entire logo is contained within a square, with the bottom left corner of the square being solid black.

# A AGUNG LATEX

## rer of Latex Gloves

. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang Sumatera Litara - Indonesia +62-61 - 8459170 (Hunting) Fax : +62-61 - 8459180 E-mail : [e-mail]

Image /page/4/Picture/4 description: The image is a logo for "TUV CERT" with the text "DIN EN ISO 9002 : 1994 Certificate 01 100 009146" below it. The logo is contained within a square with rounded corners. The text is in black and the background is white.

### ANNEXURE II

## INDICATION FOR USE

Applicant

: PT. Maja Agung Latexindo

KO 6270

510(k) Number (if known)

: Powder Free Latex Examination Gloves, Black

Indication for use

Device Name

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 (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)

Shila f. Mayhing 180

General Hospital

Devices

K 062709