POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE

K030560 · Pt.Shamrock Manufacturing Corp. · LYY · Mar 21, 2003 · General Hospital

Device Facts

• Record ID: K030560
• Device Name: POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
• Applicant: Pt.Shamrock Manufacturing Corp.
• Product Code: LYY · General Hospital
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Powder-free latex examination gloves; disposable; worn on examiner's hands. Function: barrier protection to prevent cross-contamination between patient and examiner in medical settings. Device features grape aroma and low protein content (50 micrograms or less of total water extractable protein per gram). Manufactured to meet ASTM D 3578-01ae2 standards for physical properties including tensile strength and elongation. Used by healthcare professionals during patient examinations.

Clinical Evidence

No clinical data. Bench testing only. Device certified to meet or exceed ASTM D 3578-01ae2 standards for physical properties (tensile strength, ultimate elongation) and FDA pinhole requirements.

Technological Characteristics

Latex material; powder-free; grape aroma; low protein (≤50 µg/g). Dimensions: 220-230mm length, 80-120mm palm width, 0.08mm minimum thickness. Physical properties: ≥18 MPa tensile strength (before aging), ≥650% ultimate elongation (before aging). Meets ASTM D 3578-01ae2 standards.

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.

Predicate Devices

• Class I Examination Gloves 80 LYY (meeting ASTM D 3578-01ae2)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with a four-leaf clover in the background. The letters 'SMC' are written across the clover. The logo is circular and has a black and white color scheme. The image appears to be a scan of a printed document.

K030560

PT. Shamrock
Manufacturing
Corpor

Image /page/0/Picture/2 description: The image contains two logos. The logo on the left has a triangle with the words "Tov Rheinland Product Safety" underneath. The logo on the right has the letters "GM" with a medical symbol in the middle of the letters.

Image /page/0/Picture/3 description: The image shows a close-up of a logo or emblem, possibly related to a certification or quality standard. The logo includes the letters "TUV" in a stylized font, along with the text "EN ISO 9002". The text is small and somewhat difficult to read, but it appears to be part of a certification mark.

Image /page/0/Picture/4 description: The image contains a CE marking, which consists of the letters 'C' and 'E' in a specific form. The CE marking is a symbol indicating that a product meets the health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The marking is often found on a wide range of products, including electronics, toys, and machinery, to demonstrate compliance with EU regulations.

Page Numbers 1 of 2

### "510 (K)" SUMMARY

MAR 2 1 2003

(1) Name of applicant Address

: DR. SUPENO SURYA, MBA PhD : PT. SHAMROCK Manufacturing Corp. Jl. Pemuda No. 11 Medan 20151 - Indonesia Phone No. : 62-61-4558888 Fax No. : 62-61-4520588

Contact person in U.S.A

: Emmy Tjoeng Fax No. : 909-591-8878

- (2) Device details Trade Name
: Powder free Latex Examination Gloves with Grape Centains souncym or less of total syfracts

Classification Name

: Powder free Latex Examination Gloves with Grape

- (3) Product Code
: 80 LYY

- (4) Equivalent device legally marketed
: Class I Examination Gloves 80 LYY meeting ASTM D 3578-01ae2

OFFICE :

Jl. 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 a four-leaf clover in a circle. The letters "MC" are written across the clover. The logo is black and white and has a vintage look.

r. Shamrock Manufacturing

Image /page/1/Picture/2 description: The image contains two logos side by side. The logo on the left has a triangle with two curved lines inside, along with the text "TUV Rheinland Product Safety". The logo on the right has the letters "GM" in a stylized font, with additional text below and to the right of the letters. The text below the letters appears to be "Guarantee Mark Corporation" and "Approved medical system".

Image /page/1/Picture/3 description: The image shows a logo with the text "TUV CERT" in a stylized font. Below the logo, the text "DIN EN ISO 9002" is printed. The text "Certificate 01 100 00074" is printed below that. The logo and text are enclosed in a rectangular border.

Image /page/1/Picture/4 description: The image shows a white square with rounded corners. Inside the square are the letters 'CE' in bold, black font. The letters are stacked horizontally, with the 'C' on the left and the 'E' on the right. This is the CE marking, a symbol indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.

Page Numbers 2 of 2

#### K030560

F

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

(6) Technological characteristic of the gloves.

#### a. Dimensions

| 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 |
| | | | | 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 our gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pinhole requirement. Meets labeling claim.

44

#### OFFICE :

Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone [phone] (Hunting) - 452 0688 - 452 6688 - 4520631 Fax. [phone] E-mail : [e-mail]

#### FACTORY : .

JI. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone [phone] Fax. [phone] 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

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

Re: K030560

Trade/Device Name: Powderfree Latex Examination Gloves with Grape Aroma 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 18, 2003 Received: February 21, 2003

Dear Ms. Emmy 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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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 (301) 594-46__ 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 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

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Image /page/4/Picture/0 description: The image shows a black and white logo with the letters "SMC" in a stylized font superimposed over a four-leaf clover. The clover and letters are contained within a circle. The logo has a slightly distressed or vintage appearance, with some areas of the image appearing faded or worn.

Image /page/4/Picture/1 description: The image shows the text "PT. Shamrock Manufacturing Corpora". The text is in a bold, sans-serif font. The words are stacked on top of each other, with "PT. Shamrock" on the top line, "Manufacturing" on the second line, and "Corpora" on the third line. The text is black and the background is white.

Image /page/4/Picture/2 description: The image shows four different certification logos. The first logo is the "TUV Rheinland Product Safety" certification mark, which features a triangle above the text. The second logo is a medical device certification mark. The third logo is the "TUV CERT DIN EN ISO 9002" certification mark, with the certificate number 01 100 006971. The fourth logo is the CE marking, which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.

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## ANNEXURE II

# INDICATION FOR USE

Applicant Device Name Indication for use

: PT. SHAMROCK Manufacturing Corp. : Powderfree Latex Examination Gloves with Grape. Four : Contains so migm ac less of fotal Water Extrac

favor Powderfree Latex Examination Gloves with Grape is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination betyeen patient and examiner.

(signature)

DR.SUPENO SURYA, MBA PhD

(Type Name) Feb 18, 2003

(date)

Olin S. Lim

(Division Sign-Off) (Division Sign of Anesthesiology) (Division of Anestal Division Control, Dent

510(k) Number: K03052

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