ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR

K040503 · Wrp Asia Pacific Sdn. Bhd. · KGO · Mar 16, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040503
• Device Name: ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are made of synthetic rubber lates intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, powder-free, polymer-coated polyisoprene surgical gloves; available in natural or turquoise (blue/green) colors; coated with Aloe Vera. Used by surgeons and operating room personnel to provide a protective barrier for surgical wounds against contamination. Device functions as a physical barrier; no electronic or mechanical components. Manufactured to meet ASTM D 3577-01aE2 and FDA 21 CFR 800.20 standards.

Clinical Evidence

Bench testing only. Testing included dimensions, physical properties, freedom from pinholes (ASTM D 3577-01aE2, FDA 21 CFR 800.20), powder residual (ASTM D 6124-01 < 2 mg/glove), and biocompatibility (primary skin irritation and dermal sensitization in rabbits).

Technological Characteristics

Material: Synthetic polyisoprene rubber. Coating: Polymer and Aloe Vera. Standards: ASTM D 3577-01aE2 (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder residual). Biocompatibility: Passed primary skin irritation and dermal sensitization tests. Sterilization: Sterile.

Indications for Use

Indicated for use by surgeons and operating room personnel to protect surgical wounds from contamination. No specific age or gender restrictions.

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.

Predicate Devices

• Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile (K032942)

Submission Summary (Full Text)

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

Image /page/0/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, with the "W" and "R" overlapping. The text "WRP Asia Pacific Sdn Bhd" is written in a smaller, sans-serif font to the right of the logo. The text is black and the background is white.

1 4 7 8 1 7 V

X040503

MAR 1 6 2004

# SPECIAL 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] |

25 FEB 2004 Date of Summary Prepared:

### 2.0 Contact Person:

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

## Modified Device Identification: 3.0

| Trade Name: | 1) Aloetouch, and<br>2) Multiple or Customers' Trade Name |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free, Polymer Coated Polyisoprene Surgical Gloves,<br>Sterile, Coated with Aloe Vera, Natural colour or Turquoise<br>(Blue/Green) colour |
| 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 Class Fromuer Free Dynanete D 3577 - 01a22 Type 2 and FDA 21 CFR 800.20.

.

### Description of Device Modification: 5.0

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour is equivalent to the exiting model, i.e. Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K032942.

# Vour Dartnar In Dentertinn"

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

Image /page/1/Picture/1 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font, enclosed in a rounded, black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a smaller, black font. The text is aligned horizontally with the logo.

The differences in this submission are

- With Aloe Vera coated on surgical gloves, a )
- Without colour additive, i.e. natural colour or ())
- With colour additive, i.e. turquoise (blue/green) colour ( )
- Colour additive is added for Turquoise (Blue/Green) Surgical Gloves and . will be subjected to design controls process whereby, risk assessment will be conducted to identify the hazards and estimate the risks of colour changed (Refer to Section 5 - Design Control Activities for the modified Device)

The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour meets all the requirements of ASTM standard D 3577 - 01a6 and FDA 21 CFR 800 20

#### Intended Use of the Device: 6.0

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are made of synthetic rubber lates intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination

### Summary of Technological Characteristics for the Modified Device: 7.0

The Powder Free, Polymer Coated Polysoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are summarized with the following technological characteristics compared to ASTM or equivalent standards

Page 2 of 3

# Your Partner In Protection"

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

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 bold, sans-serif font, with the letters arranged in a slightly overlapping fashion. To the right of the letters is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817V".

| CHARACTERISTICS | STANDARDS | DEVICE 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 Residual | 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 Conclusion:

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour or Turquoise (Blue/Green) colour will perform with Abov verla, Ravalance standards referenced in section 7 above and according to the glove portomansequirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

# Vour Partner In Protection"

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

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 stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

MAR 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terence Lim Manager, QA/RA WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang. Selangor Darul Ehsan, MALAYSIA

Re: K040503

Trade/Device Name: Aloetouch Powder Free Polymer Coated Polyisoprene Surgical Gloves, Sterile Coated with Aloe Vera (Blue/Green) Color Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 25, 2004 Received: February 27, 2004

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.

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

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,

Susa Runor

V 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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font, with the text "WRP Asia Pacific Sdn Bhd" to the right of the logo. Below the company name is the number sequence "1 4 : 8 1 7 V".

# INDICATIONS FOR USE

| Applicant: | WRP Asia Pacific Sdn Bhd |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K040503 |
| Device Name: | POWDER FREE, POLYMER COATED<br>POLYISOPRENE SURGICAL GLOVES,<br>STERILE, COATED WITH ALOE VERA,<br>NATURAL COLOUR OR TURQUOISE<br>(BLUE/GREEN) COLOUR |

Indications For Use:

The surgeon's glove is a device made of synthetic rubber latex intended to be I he surgeon's glove is a device made of sersonnel to protect a surgical wound from contamination.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Martha O'Love
Interim Branch Chief/NCB

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

Page 1 of of