LATEX EXAMINATION GLOVES- POWDER FREE, BLUE

K011712 · Pt.Shamrock Manufacturing Corp. · LYY · Jul 17, 2001 · General Hospital

Device Facts

• Record ID: K011712
• Device Name: LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
• Applicant: Pt.Shamrock Manufacturing Corp.
• Product Code: LYY · General Hospital
• Decision Date: Jul 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free examination glove is a 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 glove; disposable; worn on examiner's hand. Function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical/medical settings. No complex electronics or software.

Clinical Evidence

No clinical data. Bench testing only; device meets or exceeds ASTM D 3578-99 standards and FDA pinhole requirements.

Technological Characteristics

Latex material; powder-free. Dimensions: 280mm length; palm width 80-110mm; thickness 0.20mm. Physical properties: Tensile strength 21 MPa (before aging), 18 MPa (after aging); Ultimate elongation 750% (before aging), 700% (after aging). Complies with ASTM D 3578-99.

Indications for Use

Indicated for use as a disposable medical 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.

Submission Summary (Full Text)

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JUL 1: 7 2001

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## PT. SHAMROCK MANUFACTURING CORPORATION

# Manufacturer of Latesx & Nitrillo Glovos.
Ji. Roya Bodas Namoramie PS, IV Kin 9

Jl. Roqa Média, Mapiripana P5, IV, Km. 2

Kab. Dell Seydang - Burnut - Indonesia
Tol: (62-01) 7030008 : Fax : [phone]

Tel: [phone] Fax : [phone]

DR. SUPENO SURYA, MBA, PAD

SHAMROCK Manufacturing Company

: 626-913-1498

: Powder Free - Latex Examination Gloves

: Powder Free - Latex Examination Gloves

J1. Raya Medan - Namorambe PS IV 31. Kaya Mosed
Kabupatén Deli Serdang - Indonesia
Phone No.

Fax No. : : 62-61-703-007

: Emmy Tjoeng

Fax No.

: 80 L Y Y

Page Numbers I of 2

**"510 (K)" SUMMARY**

K Olll.

( 1 ) Name of applicant Address

Contact person in U.S.A.

(2) Device details Trade Name

Classification Name

(3) Product Code

marketed

(4) Equivalent device legally

#### : : Class I Examination Gloves 80 L YY meeting ASTM D 3578-99

રક

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# PT. SHAMROCK MANUFACTURING CORPORATION

### Manufacturer of Latex & Nitrile Gloves

JI. Raya Medan - Namorambe PS. IV Km. 9 Kab. Deli Sordang - Sumut - Indonesia Tel: {62-61} 7030008 ; Fax : [phone]

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(5) Intended use

: A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ー …… '

#### (6) Technological characteristic of the gloves.

#### Dimensions a

| Dimensions<br>Sizes | Samll | Medium | Large | X-Large |
|----------------------------------------------------------------------|----------------------|----------------------|----------------------|----------------------|
| Length mm (min.)<br>PalmWidth mm | 280<br>80±10 | 280<br>95±10 | 280<br>111±10 | 280<br>≥ 110 |
| Thickness<br>1. Cuff mm (min)<br>2. Palm mm(min)<br>3. Finger Tip mm | 0.20<br>0.20<br>0.20 | 0.20<br>0.20<br>0.20 | 0.20<br>0.20<br>0.20 | 0.20<br>0.20<br>0.20 |
| b. Physical Properties | | | | |

| | Before ageing | After ageing<br>at 70°C 168 hrs. |
|---------------------|----------------|----------------------------------|
| Tensile Strength | : 21 Mpa (min) | 18 Mpa (min) |
| Ultimate Elongation | : 750 % (min.) | 700 % (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

Gloves meet or exceed the ASTM D 3578-99 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JUL 1 7 2001

PT. Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Official Correspondent Shamrock Manufacturing Incorporated 889 South Azusa Avenue City of Industry, California 91748

Re : K011712 Latex Examination Gloves- Powder Trade/Device Name: Free, Blue 880.6250 Regulation Number: Regulatory Class: I Product Code: LYY Dated: May 25, 2001 June 4, 2001 Received:

Dear Ms. Tjoeng:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Tjoeng

In addition, FDA may publish further announcements action. action. In addrerer, In the Federal Register. Please note: concerning your device in anket notification submission does this response to your premaint have under sections 531 not arrect any obrigation for devices under the Electronic Chrough 542 of the Act 101 xeviews, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your 510(x) premaince of your device to a legally Linding of Subscancial Cquiralits in a classification for your marketed predicate device robates in the to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulacion (21 crk Fare 301 and se contact the Office of Villo draghostic deviced// promosonally, for questions on Compliance at (501) devertising of your device, please contact the Dromocron and advertibility of Journal (1301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . Other general premation on your responsibilities under the Act may be Information on your responsof Small Manufacturers Assistance oblained from the biributes [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas Wlodarski

Timo thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### PT. SHAMROCK MANUFACTURING CORPORATION

#### Manufacturer of Latex & Nitrile Gloves

11 Rays Medan - Namorambo PS Kah, Dali Sordaina - Sumart - In Tel: [phone] ; Fax : (62-61) 70

#### ANNEXURE II

#### INDICATION FOR USE

Applicant Device Name Indication for use : Supeno Surya : Powder Free - Latex Examination Glov

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

(signature)

DR. Supeno Surya, MBA, PhD
(Type Name)

July 06, 2001
(date)

Oline S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .