ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA

K032647 · Wrp Asia Pacific Sdn. Bhd. · KGO · Nov 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032647
• Device Name: ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Powder-free, sterile, turquoise-colored neoprene surgical glove coated with Aloe Vera. Designed for use by surgeons and operating room personnel to provide a protective barrier between the wearer and the patient's body, fluids, waste, or environment. Device functions as a physical barrier to prevent cross-contamination. No electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Synthetic rubber latex (neoprene). Coating: Aloe Vera. Form factor: Sterile, powder-free surgical glove. Standards: ASTM D 3577-01aE2 (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder-free), FDA 21 CFR 800.20. Biocompatibility: Primary skin irritation and dermal sensitization testing passed.

Indications for Use

Indicated for use by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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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K032647

NOV - 7 2003

## 510(k) SUMMARY

#### 1.0 Submitter:

| Name: | WRP Asia Pacific Sdn Bhd |
|------------|-------------------------------------------------------------------------------------------------------------|
| Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 25 AUG 2003

#### 2.0 Contact Person:

| Name: | Mr. Terence Lim |
|------------|-----------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of the device:

| Trade Name: | 1. Aloetouch, and<br>2. Multiple or Customer's Trade Name |
|----------------------|-------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera. |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |

#### Identification of The Legally Marketed Device: 4.0

Class I Powder Free Synthetic rubber latex Surgeon's gloves, 79KGO, that meets all
the requirements of ASTM standard D 3577 – 01a22 Type 2 and FDA 21 CFR 800.20.

#### 5.0 Description of The Device:

The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.

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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed in a black oval shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817 V".

#### 6.0 Intended Use of the Device:

The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

#### Summary of The Technological Characteristics of The Device: 7.0

The Powder Free Neoprene Surgical Gloves, Sterile, Turquoise Colour and coated with Aloe Vera are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets<br>< 2 mg/glove |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(Not a primary skin irritant) |
| | Dermal Sensitization | Passes<br>(Not a contact sensitizer) |

#### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a black oval shape, followed by the text "WRP Asia Pacific Sdn Bhd" in a bold, sans-serif font. Below the company name is the number "147817 V".

#### Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### 10.0 Conclusion

It can be concluded that the Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV - 7 2003

Mr. Terence Lin Associate Manager, Quality Assurance Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan MALAYSIA

Re: K032647

Trade/Device Name: Aloetouch Powder Free Neoprene Surgical Gloves, Sterile, Turquoise Color Coated with Aloe Vera Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 25, 2003 Received: August 27, 2003

Dear Mr. Lim:

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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Page 2 - Mr. Lim

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,

Susakunos
fr. Shih-Li Liu, Ph.D.

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

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Image /page/5/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a more standard font. Below the company name is the number 147817V.

### INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

510(k) Number (if known):

\$\k_{0.32647}\$

Device Name:

FREE NEOPRENE POWDER SURGICAL STERILE, GLOVES. TURQUOISE COLOUR AND COATED WITH ALOE VERA

Indications For Use:

The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Pat By Lales Board Chy 18/6/03

510(k) Number:

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter _____________________________________________________________________________________________________________________________________________________________