LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE

K030134 · Pt.Shamrock Manufacturing Corp. · LYY · Mar 25, 2003 · General Hospital

Device Facts

• Record ID: K030134
• Device Name: LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE
• Applicant: Pt.Shamrock Manufacturing Corp.
• Product Code: LYY · General Hospital
• Decision Date: Mar 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Latex Examination Gloves Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Device Story

Latex examination gloves with neoprene lining; disposable; worn on examiner's hands. Function as physical barrier to prevent contamination between patient and examiner. Used in clinical settings by healthcare professionals. Device provides protection during examinations; reduces risk of cross-contamination.

Clinical Evidence

No clinical data. Bench testing only; device meets or exceeds ASTM D 3578-01ae2 standards for physical properties (tensile strength, elongation) and FDA pinhole requirements.

Technological Characteristics

Latex examination gloves with neoprene lining; powder-free. Dimensions (length 220-230mm; thickness 0.08mm min). Physical properties: Tensile strength 18 MPa (before aging), 14 MPa (after aging); Ultimate elongation 650% (before aging), 500% (after aging). Meets ASTM D 3578-01ae2. Contains 50 micrograms or less of total water extractable protein per gram.

Indications for Use

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letters "SMC" superimposed over a four-leaf clover. The clover is positioned inside a circle. The letters "SMC" are horizontally aligned across the center of the clover. The logo appears to be a vintage or retro design, with a slightly distressed or aged look.

K030134

Address

Image /page/0/Picture/1 description: The image shows the text "Ft. Shamrock Manufacturing Corpora" in a bold, distressed font. The text is arranged in three lines, with "Ft. Shamrock" on the top line, "Manufacturing" on the second line, and "Corpora" on the third line. The font style gives the text a rough, textured appearance.

Image /page/0/Picture/2 description: The image contains two logos side by side. The logo on the left has a triangle with two horizontal lines inside of it, and below the triangle is the text "TUV Rheinland Product Safety". The logo on the right has a stylized "GN" with a caduceus symbol on top of the letters. Below the letters is the text "Global-Tec Hygiene Approved Medical Device".

Image /page/0/Picture/3 description: The image contains two logos. The logo on the left is a square with rounded corners and contains the letters "UV" in a bold, sans-serif font. Below the letters, the text "ISO 9002" is visible, followed by some smaller text. The logo on the right is a square with rounded corners and contains the letter "C" in a bold, sans-serif font.

K030134

MAR 2 5 2003

## : DR. SUPENO SURYA, MBA PhD (1) Name of applicant : PT. SHAMROCK Manufacturing Corp. Jl. Pemuda No. 11 Medan 20151 - Indonesia Phone No. : 62-61-4558888 : 62-61-4520588 Fax No. : Emmy Tjoeng Contact person in U.S.A : 909-591-8878 Fax No. (2) Device details Trade Name : Latex Examination Gloves Powder Free With Lined. C on thin as from a : Latex Examination Gloves Powder Free with Neoprene Classification Name Lined. (3) Product Code : 80 LYY

"510 (K)" SUMMARY

(4) Equivalent device legally marketed

: Class I Examination Gloves 80 LYY meeting ASTM D 3578-01ae2

- (5) Intended use
: Latex Examination Gloves Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

#### OFFICE :

JI. Pemuda No. 11 Medan - 20151 - Indonesia Phone [phone] (Hunting) - 452 0688 - 452 6688 - 4520638 Fax. [phone] E-mail : [e-mail]

FACTORY :

Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone [phone] Fax. [phone] E-mail : [e-mail].

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Image /page/1/Picture/0 description: The image shows a logo with the letters "SMC" in a bold, sans-serif font, superimposed over a four-leaf clover. The clover and letters are contained within a circle, which has a thick, dark outline. The image appears to be a black-and-white scan or photocopy, as there is some noise and imperfections throughout the image.

**PT. Shamrock**
**Manufacturing**
**Corpora**

Image /page/1/Picture/2 description: The image contains two logos side by side. The logo on the left has a triangle with the letters "TUV" above the words "Rheinland Product Safety". The logo on the right has the letters "GM" with a medical symbol in the middle. There is text below the letters "GM", but it is too small to read.

Image /page/1/Picture/3 description: The image contains two cropped images of signs. The sign on the left has a white background with a black border. There is a black drawing of a planet with rings on the sign. The sign on the right has a white background with a black border. The sign has a large, bold, black letter C on it.

#### K030134

(6) Technological characteristic of the gloves.

| a. Dimensions<br>Sizes | Small | Medium | Large | X-Large |
|------------------------|-----------|----------------|------------|----------------------------------|
| Length mm (min.) | 220 | 230 | 230 | 230 |
| Palm Width mm | $80\pm10$ | $95\pm10$ | $111\pm10$ | $120\pm10$ |
| Thickness | | | | |
| 1. Cuff mm (min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 2. Palm mm(min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 3. Finger Tip mm | 0.08 | 0.08 | 0.08 | 0.08 |
| 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 the gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

#### OFFICE :

OFFICE: 0151 - indonesia Phono (62-61) : [e-mail]

## FACTORY : ·

Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Seriang Phone [phone] Fax. [phone]
Partis (62-61) 703 000 Bernet Bernikel (Giograch(Giograsat pel id E-mail : [e-mail].

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Image /page/2/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 eagle with three lines forming its body and head. The words "HUMAN SERVICES • USA" and "DEPARTMENT OF" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2003

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

Re: K030134

Trade/Device Name: Latex Examination Gloves Powder Free with Neoprene Lined, Green Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: February 4, 2003 Received: March 3, 2003

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 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/dsma/dsmamain.html

Sincerely yours.

Susan Rurrer

Susan Runner, DDS, MA Interim 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 is a black and white logo. The logo is a circle with a four-leaf clover inside. The letters "SMC" are written in white across the clover. The clover is black, and the circle is outlined in black.

# PT. Shamrock Manufacturing

Image /page/4/Picture/2 description: The image shows four different certification logos. The first logo has a triangle above the text "TUV Rheinland Product Safety". The second logo has a medical symbol above the text "Approved medical device". The third logo has the text "TUV CERT DIN EN ISO 9002 Certificate 01 100 000971". The fourth logo has the letters "CE".

## ANNEXURE II

K030134

## INDICATION FOR USE

Applicant Device Name Indication for use : PT. SHAMROCK Manufacturing Corp. : Latex Examination Gloves Powder Free with Neoprene lined : Contains so migm or less of fotal water Extractatore Professo per gram

Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

(signature)

(signature)

DR.SUPENO SURYA, MBA PhD

(Type Name)

JAN 03. 2003

(date)

Qum S. Lin

Division Sign-Off) ivision of Anesthesiology, General H Infection Control. Dental Dental

510(k) Number: K030134