POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

K052382 · Pt.Shamrock Manufacturing Corp. · LZA · Sep 15, 2005 · General Hospital

Device Facts

• Record ID: K052382
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
• Applicant: Pt.Shamrock Manufacturing Corp.
• Product Code: LZA · General Hospital
• Decision Date: Sep 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Disposable nitrile examination glove; worn on examiner's hand; provides barrier protection to prevent cross-contamination between patient and examiner in clinical settings. Device is non-sterile, powder-free, and blue-colored. Manufactured to meet ASTM D 6319-00ae2 standards for physical properties and dimensions. Used by healthcare professionals during patient examinations.

Clinical Evidence

No clinical data. Bench testing only, demonstrating compliance with ASTM D 6319-00ae2 standards for physical properties, dimensions, and pinhole requirements.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable, powder-free, blue examination glove. Dimensions: 220-230mm length, 80-120mm palm width, 0.08mm minimum thickness. Physical properties: 14 MPa min tensile strength, 500% min ultimate elongation (before aging). Standards: ASTM D 6319-00ae2. Non-sterile.

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 LZA (meeting ASTM D 6319-00ae2)

Submission Summary (Full Text)

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

SEP 1 5 2005 .

## PT. Shamrock Manufacturing Corpora

Jalan Pemuda No. 11, Medan-20151, N. Sumatra – Indonesia Ph. ([phone] Fax. [phone] Email. smç@shamrock-id.com ==============================================================================================================================================================================

## K052382 "510 (K)" SUMMARY

| (1) Name of applicant | : RUDI SALIM |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | : PT. SHAMROCK Manufacturing Corp.<br>Jl. Pemuda No. 11<br>Medan 20151 - Indonesia<br>Phone No. : 62-61-4558888 ,- 4558629, - 4520675<br>Fax No. : 62-61-4520588 |
| 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 Nitrile Examination Gloves, Blue |
| Classification Name | : Powder Free Nitrile Examination Gloves, Blue |
| (3) Product Code | : 80 LZA |
| (4) Equivalent device legally marketed | : Class I Examination Gloves 80 LZA<br>meeting ASTM D 6319-00ae2 |
| (5) Intended use | : Powder free Nitrile Examination Glove is a disposable<br>device intended for medical purpose that is worn on<br>examiner's hand to prevent contamination between patient<br>and examiner. |

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

| Technological characteristic of the gloves.) | | | | |
|----------------------------------------------|--------------------------------------|-----------|----------------------------------|--------------|
| a. Dimension | Small | Medium | Large | X-Large |
| Length mm (min.) | 220 | 230 | 230 | 230 |
| Palm Width mm | $80\pm10$ | $95\pm10$ | $110\pm10$ | $120\pm10$ |
| Thickness<br>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 | : 14 Mpa (min) | | | 14 Mpa (min) |
| Ultimate Elongation | : 500 % (min.) | | | 400 % (min.) |
| c. Performance Requirement | | | | |
| Characteristic | Related Defects | | Inspection<br>Level | AQL |
| Freedom from holes | Holes | | I | 2.5 |
| Dimensions | Width Length<br>& Thickness | | S-2 | 4 |
| Physical Properties | Before and<br>after ageing | | S-2 | 4 |
| Powder-free Residue | Exceeds maximum limit | | N=5 | N/A |
| Powder Amount | Exceeds recommended<br>maximum limit | | N=2 | N/A |

- (6) T
- (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 our finished powder free nitrile examination gloves meet or exceed the ASTM D 6319-00ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines above and below them.

## Public Health Service

SEP 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052382

Trade/Device Name: Powder Free Nitrile Examination Glove, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 19, 2005 Received: September 1, 2005

Dear Ms. Tjoeng:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars than and the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have occh reclassince in asses approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The r ou may, ulercrore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs neements 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 I loase be advised that I browner that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally Federal statutes and registanents, including, but not limited to: registration and listing (21 Comply with an the For 81 cFR Part 801); good manufacturing practice requirements as set CFR Part 607); adomig (Dr CFR Part 820); and if applicable, the electronic forth in the quant) by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herems (2005) - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 10 This letter will and will and with gof substantial equivalence of your device to a legally promaticated predicated. The Pro Massification 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 If you desire specific acriveliance at [phone]. Also, please note the regulation entitled, eonidor the office of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational 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,

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

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

## INDICATION FOR USE

| Applicant | : PT. Shamrock Manufacturing Corpora |
|---------------------------|------------------------------------------------|
| 510(k) Number (if known): | K062382 |
| Device Name | : Powder Free Nitrile Examination Gloves, Blue |
| Indication for use | : |

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) AND/OR Over-The-Counter Use (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)

Shade A. Murphy, KG 9/15/05

ion Sign-Off) (Divis (Division of Anesthosiology, General Hospital, Infection Control. Dental

510(k) Number: `K052382