ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50

K032464 · Wrp Asia Pacific Sdn. Bhd. · KGO · Aug 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032464
• Device Name: ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) are made of natural 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

Natural rubber latex surgical gloves; sterile; coated with Aloe Vera; powder-free. Designed for use by surgeons and operating room personnel to prevent cross-contamination between personnel and patients/environment. Modification from predicate involves removal of color additive. Device provides physical barrier protection. Performance verified against ASTM D 3577-01aE2 standards for dimensions, physical properties, and pinhole resistance. Protein content labeled at 50 micrograms or less per gram. Biocompatibility confirmed via primary skin irritation and dermal sensitization testing.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D 3577-01aE2 (dimensions, physical properties, pinhole resistance), ASTM D 6124-01 (powder residual < 2 mg/glove), and ASTM D 5712-99 (protein level < 50 µg/g). Biocompatibility testing (primary skin irritation and dermal sensitization) passed.

Technological Characteristics

Natural rubber latex surgical gloves; powder-free; coated with Aloe Vera. Meets ASTM D 3577-01aE2 for dimensions and physical properties. Protein content < 50 µg/g (ASTM D 5712-99). Powder residual < 2 mg/glove (ASTM D 6124-01). Biocompatible (non-irritant, non-sensitizer). Sterile.

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.

Predicate Devices

• Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) (K022442)

Submission Summary (Full Text)

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

K032464

WRP Asia Pacific Sdn Bhd 1 コフ良さアレ

AUG 2 2 2003

## 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] |

Date of Summary Prepared: 0 7 AUG 2003

#### 2.0 Contact Person:

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

#### 3.0 Modified Device Identification:

| Trade Name: | 1) Aloetouch, and<br>2) Multiple or Customers' Trade Name |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) |
| 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 natural rubber latex surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 01a22 Type 1 and FDA 21 CFR 800.20.

#### Description of Device Modification: 5.0

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.

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## Your Partner In Protection"

ATTACHMENT 1

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K032464

WRP Asia Pacific Sdn Bhd '

The difference in this submission is:

1 4 7 8 1 7 V

- No colour additive is added. a)
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 Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.

#### Intended Use of the Device: 6.0

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) are made of natural 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 Technological Characteristics for the Modified Device: 7.0

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) 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 Residual | ASTM D 6124 - 01 | Meets<br>< 2 mg/glove |
| Protein Level | ASTM D 5712 – 99 | < 50 µg/g |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(Not a primary skin irritant) |
| | Dermal Sensitization | Passes<br>(Not a contact sensitizer) |

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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 bold, sans-serif font, with the "WRP" on the right in a smaller font. Below the logo is the number "147817 V".

# K032464

#### 8.0 Conclusion:

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 2 2003

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

### Re: K032464

Trade/Device Name: Powder Free Latex Surgical Glove Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 Micrograms or less) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 7, 2003 Received: August 11, 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 (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), 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 Ruoser

Susan Runner, DDS, MA Interim 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 bold, stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a smaller, but still prominent font. Below the company name is the number "147817 V".

## INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

510(k) Number (if known): KC32464

Device Name:

| POWDER FREE LATEX SURGICAL GLOVES, |
|-------------------------------------|
| STERILE, COATED WITH ALOE VERA AND |
| WITH PROTEIN CONTENT LABELING CLAIM |
| (50 MICROGRAMS OR LESS) |

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qian S. Lin

ion of Anesthesiology, General Hospital, on Control, Dental I

510(k) Number. K032464

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter | |
|------------------|--|
|------------------|--|

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## Voire