POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)

K020019 · Wrp Asia Pacific Sdn. Bhd. · KGO · Jan 23, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020019
• Device Name: POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jan 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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

Sterile, powder-free, polymer-coated natural rubber latex surgical gloves; intended for use by surgeons and operating room personnel to prevent cross-contamination between healthcare staff and patients. Device acts as a physical barrier against body fluids, waste, and environmental contaminants. Performance verified against ASTM D 3577-01E1 standards for dimensions, physical properties, and freedom from pinholes. Protein content is labeled at 50 micrograms or less per gram, tested per ASTM D 5712-99. Biocompatibility confirmed via primary skin irritation and dermal sensitization testing. Used in clinical and surgical settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical properties, dimensions, freedom from pinholes (ASTM D 3577-01E1), powder-free residue (ASTM D 6124-01), protein content (ASTM D 5712-99), and biocompatibility (primary skin irritation and dermal sensitization).

Technological Characteristics

Natural rubber latex surgical gloves; polymer-coated; powder-free (< 2 mg/glove). Meets ASTM D 3577-01E1 (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder residue), and ASTM D 5712-99 (protein level < 50 µg/g). Biocompatible (non-irritant, non-sensitizer). Sterile.

Indications for Use

Indicated for use by surgeons and operating room personnel to protect surgical wounds from contamination. Device is made of natural rubber latex.

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

• Class I Powder Free natural rubber latex Surgeon's gloves (79KGO)

Submission Summary (Full Text)

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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 white on a black rounded rectangle. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in black. Below the text is the number "147817 V".

Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

### JAN 2 3 2002

# 510(k) SUMMARY

### TEL [phone] FAX [phone] EML [e-mail] URL www.wrpworld.com

#### 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] |

28 DEC 2001 Date of Summary Prepared:

#### Contact Person: 2.0

| Name: | Mr. Yue Wah, CHOW |
|------------|-------------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of the device:

| Trade Name: | 1. Profeel and<br>2. Multiple or Customer's Trade Name |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Polymer Coated Latex Surgical Gloves, Sterile<br>(Protein Labeling Claim) (50 microgram or Loss) |
| 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 - 0111 Type 1 and FDA 21 CFR 800.20.

#### 5.0 Description of The Device:

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 0151 and FDA 21 CFR 800.20.

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WRP Asia Pacific Sdn Bhd

#### Intended Use of the Device: 6.0

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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 The Technological Characteristics of The Device: 7.0

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dimensions | ASTM D 3577 - 01E1 | Meets |
| Physical Properties | ASTM D 3577 - 01E1 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01E1<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets<br>< 2 mg/glove |
| Protein Level | ASTM D 5712 – 99 | < 50 $\mu$ g/g |
| Biocompatability | Primary Skin Irritation in<br>Rabbits<br>Dermal Sensitization | Passes<br>(Not a primary skin irritant)<br>Passes<br>(Not a contact sensitizer) |

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

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

#### 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 Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 3 2002

Mr. Yue W. Chow Head of Department, QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K020019

Trade/Device Name: Powder-Free Polymer Coated Latex Surgical Gloves, Sterile with Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4470 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: December 28, 2001 Received: January 3, 2002

Dear Mr. Chow:

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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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 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,

Timot . Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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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 inside of a black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a bold, sans-serif font. Below the text is the number "147817V".

### INDICATIONS FOR USE

| Applicant: | WRP Asia Pacific Sdn Bhd |
|---------------------------|------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K020019 |
| Device Name: | POWDER FREE POLYMER COATED LATEX<br>SURGICAL GLOVES, STERILE (PROTEIN<br>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)

OR

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

Olu S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 0

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