POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)

K012786 · Shamrock Manufacturing Company · LZA · Oct 1, 2001 · General Hospital

Device Facts

• Record ID: K012786
• Device Name: POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
• Applicant: Shamrock Manufacturing Company
• Product Code: LZA · General Hospital
• Decision Date: Oct 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powderfree Nitrile Neoprene 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 neoprene examination gloves; worn on examiner's hands; intended to prevent cross-contamination between patient and examiner in medical settings. Device acts as a physical barrier. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing against ASTM D6319-00a standards.

Technological Characteristics

Material: Nitrile Neoprene. Form factor: Disposable examination gloves in sizes Small, Medium, Large, X-Large. Thickness: 0.05 mm (cuff, palm, finger tip). Tensile strength: 14 MPa (min). Ultimate elongation: 500% (min) before aging, 400% (min) after aging. Standards: ASTM D6319-00a. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination 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)

Submission Summary (Full Text)

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OCT - 1 2001

Image /page/0/Picture/1 description: The image shows a black and white logo or emblem. The logo is circular and features a four-leaf clover in the center. The letters "MC" are superimposed on the clover. The image appears to be a scan or photocopy, as the edges are slightly rough and there is some distortion.

## PT. SHAMROCK MANUFACTURING CORPORATION

#### Manufacturer of Latex & Nitrile Gloves

Tol: (62-61) 7030008 : Fax : [phone]

K012786

Page Numbers 1 of 2

"510 (K)" SUMMARY
K012786

(1) Name of applicant Address

: RUDY SALIM SHAMROCK Manufacturing Company J1. Raya Medan - Namorambe PS IV Kabupaten Deli Serdang - Indonesia Phone No. : 62-61-7030008 : 62-61-7030007 Fax No.

Contact person in U.S.A

: Emmy Tjoeng : 626-913-1498 Fax No.

(2) Device details Trade Name

: Powder free Nitrile Neoprene Examination Gloves

Classification Name

: Powder free Nitrile Neoprene Examination Gloves

- (3) Product Code : 80 LZA
- (4) Equivalent device legally : Class I Examination Gloves 80 LZA marketed mecting ASTM D6319-00a

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K012786

- : Powder free Nitrile Neoprene Examination Glove is a (5) Intended use 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 | | $80\pm10$ | $95\pm10$ | $111\pm10$ | $120\pm10$ |
| Thickness | | | | | |
| 1. Cuff mm (min) | | 0.05 | 0.05 | 0.05 | 0.05 |
| 2. Palm mm (min) | | 0.05 | 0.05 | 0.05 | 0.05 |
| 3. Finger Tip mm | | 0.05 | 0.05 | 0.05 | 0.05 |
| b. Physical Properties | | | | | |
| | | Before ageing | | | After ageing |
| | | | | | at 70°C 168 hrs. |
| Tensile Strength | | : 14 MPa (min) | | | 14 MPa (min) |
| Ultimate Elongation | | : 500 % (min.) | | | 400 % (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 ASTM D6319-00a Standard. Meets FDA pinhole requirement. Meets labeling claim.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT = 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shamrock Manufacturing Company C/O Ms. Emmy Tjoeng 889 Sotuh Azusa Avenue City Of Industry, California 91748

Re: K012786

Trade/Device Name: Powder Free Nitrile Neoprene Examination Gloves (Purple) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 16, 2001 Received: August 20, 2001

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.

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

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Page 2 - Ms. Tjoeng

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

K. Victoust

Timothy 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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Image /page/4/Picture/0 description: The image shows a logo with the letters "SME" in a stylized font. Above the letters, there is a graphic that resembles a cluster of leaves or a small tree. The entire logo is encircled by a dotted or textured border, giving it a stamp-like appearance. The image is in black and white.

# PT. SHAMROCK MANUFACTURING CORPORATION

#### Manufacturer of Latex & Nitrile Gloves

Ji. Raya Medan - Namorambe PS. IV Km. 9 Kab. Deli Serdang - Sumut - Indonesia Tel: [phone] ; Fax : [phone]

K012786

#### ANNEXURE II

### INDICATION FOR USE

Applicant Device Name Indication for use

: PT. SHAMROCK MANUFACTURING CORPORATION : Powderfree Nitrile Neoprene Examination Gloves

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

Salin

(signature)

RUDY SALIM
(Type Name)
Sept 14.01
(date)

Olin S. him

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