POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM

K030325 · Pt.Shamrock Manufacturing Corp. · LYY · Mar 28, 2003 · General Hospital

Device Facts

• Record ID: K030325
• Device Name: POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
• Applicant: Pt.Shamrock Manufacturing Corp.
• Product Code: LYY · General Hospital
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Powder free Latex Examination Gloves with bubblegum aroma 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; scented with bubblegum aroma; worn on examiner's hands; intended to provide barrier protection against cross-contamination between patient and clinician. Used in clinical settings; operated by healthcare professionals. Device functions as a physical barrier; manufactured to meet ASTM D 3578-01ae2 standards for tensile strength, elongation, and pinhole requirements. Provides protection for both patient and examiner during medical examinations.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing confirming compliance with ASTM D 3578-01ae2 standards for physical properties and FDA pinhole requirements.

Technological Characteristics

Material: Latex. Dimensions: Length 220-230mm; Palm width 80-120mm; Thickness 0.08mm (cuff, palm, finger). Physical properties: Tensile strength 18 MPa (before aging), 14 MPa (after aging); Ultimate elongation 650% (min). Standards: ASTM D 3578-01ae2. Form factor: Disposable examination glove. Scent: Bubblegum aroma.

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

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image is a black and white logo of SMC inside of a four leaf clover. The clover is inside of a circle. The letters SMC are in a sans-serif font and are stacked on top of each other.

# PT. Shamrock nufacturine

Image /page/0/Picture/2 description: The image shows four different certification logos. The first logo is a triangle with the text "TUV Rheinland Product Safety" underneath. The second logo is a stylized "GM" with text underneath. The third logo is a "TUV CERT" logo with the text "DIN EN ISO 9002 Certificate 0: 100 000071" underneath. The fourth logo is a "CE" mark.

MAR 2 8 2003

K030325

Page Numbers 1 of 2

## K030325

# "510 (K)" SUMMARY

| (1) Name of applicant<br>Address | : DR. SUPENO SURYA, MBA PhD<br>: PT. SHAMROCK Manufacturing Corp.<br>Jl. Pemuda No. 11<br>Medan 20151 - Indonesia<br>Phone No. : 62-61-455-8888<br>Fax No. : 62-61-452-0588 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person in U.S.A | : Emmy Tjoeng<br>Fax No. : 909-591-8878 |
| (2) Device details<br>Trade Name | : Powder free Latex Examination Gloves with Bubblegum Aroma |
| Classification Name | : Powder free Latex Examination Gloves with Bubblegum<br>Aroma |
| (3) Product Code | : 80 LYY |
| (4) Equivalent device legally<br>marketed | : Class I Examination Gloves 80 LYY<br>meeting ASTM D 3578-01ae2 |

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

{1}------------------------------------------------

Image /page/1/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.

Image /page/1/Picture/2 description: The image shows four different certification logos. The first logo has a triangle with the text "TUV Rheinland Product Safety" underneath. The second logo has the letters "GM" in a stylized font. The third logo has the text "TUV CERT DIN EN ISO 9002 Certificate 01 153 000671". The fourth logo has the letters "CE".

500 % (min.)

Page Numbers 2 of 2

(5) Intended use : Powder free Latex Examination Gloves with bubblegum aroma is a 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<br>Sizes | Small | Medium | Large | X-Large |
|------------------------|-----------|----------------|------------|----------------------------------|
| Length mm (min.) | 220 | 230 | 230 | 230 |
| Palm Width mm | $80\pm10$ | $95\pm10$ | $110\pm10$ | $120 \pm10$ |
| 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) |

: 650 % (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

Ultimate Elongation

We certify that our gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

### OFFICE :

Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone [phone] (Hunting) - 452 0688 - 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]

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

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

Re: K030325

Trade/Device Name: Powder Free Latex Examination Gloves with Bubblegum Aroma with 50 Micrograms or Less Protein Per Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 10, 2003 Received: January 31, 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.

{3}------------------------------------------------

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 (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 [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 Runner

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

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the logo for PT. Shamrock Manufacturing Corporation. The logo consists of a four-leaf clover with the letters SMC inside of it. To the right of the clover is the text "PT. Shamrock Manufacturing Corporation" in a bold, sans-serif font.

Image /page/4/Picture/3 description: The image shows four different certification logos. The first logo is a triangle with the text "TUV Rheinland Product Safety" below it. The second logo is a black and white logo with the letters "GM" in it. The third logo is a "TUV CERT" logo with the text "DIN EN ISO 9002 Certificate 01 100 006971" below it. The fourth logo is a white logo with a black "C" in it.

#### ANNEXURE II

# INDICATION FOR USE

Applicant Device Name Indication for use

: PT. SHAMROCK Manufacturing Corp.
: Powder free Latex Examination Gloves with Bubblegum Aroma
:
with 50 mcg/gm or less protein per glove

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

(signature)

DR.SUPENO SURYA, MBA PhD

(Type Name) 24. 03 MARCH (date)

Chin S. Lin

(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Dental Devic

510(k) Number:

#### OFFICE :

Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone [phone] (Hunting) - 452 0688 - 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]