POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM

K030157 · Wrp Asia Pacific Sdn. Bhd. · LYY · Feb 19, 2003 · General Hospital

Device Facts

• Record ID: K030157
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim 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.

Device Story

Disposable sterile latex examination glove; worn by clinicians to prevent cross-contamination between patient and examiner. Device design identical to predicate; modification limited to addition of protein content labeling claim (≤ 50 micrograms/gram). Used in clinical settings; operated by healthcare professionals. Provides barrier protection; reduces risk of patient-to-examiner contamination. Benefits include standardized protein content labeling for awareness regarding latex sensitivity.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D 3578-01aE2 for dimensions, physical properties, and freedom from pinholes. Powder residual tested per ASTM D 6124-01 (< 2 mg/glove). Protein levels verified per ASTM D 5712-95 (< 50 µg/g).

Technological Characteristics

Material: Latex. Standards: ASTM D 3578-01aE2 (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder residual), ASTM D 5712-95 (protein level). Sterile. Powder-free. Form factor: Hand-worn examination glove.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. No specific age or gender restrictions. Contraindicated for individuals with latex sensitivity, as safe use has not been established.

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

• Comfit Sterile Latex Examination Gloves (Powder Free) (K944141)

Submission Summary (Full Text)

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WRP WRP Asia Pacific Sdn Bhd

K030i57

FEB 1 9 2003

# 510(k) SUMMARY

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## 1.0 Submitter:

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

1 4 JAN 2003 Date of Summary Prepared:

### 2.0 Contact Person:

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

### 3.0 Device Identification:

| Trade Name: | 1) Comfit, and<br>2) Multiple or Customers' Trade Name |
|----------------------|--------------------------------------------------------------------------------------|
| Device Name: | Powder Free Latex Examination Gloves, Sterile with Protein<br>Content Labeling Claim |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |

### 4.0 Identification of the Legally Marketed Device:

Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a52 and FDA 21 CFR 800.20.

### 5.0 Description of the Device:

The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141.

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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 white inside of a black oval. To the right of the logo is the company name in black text. Below the company name is the number sequence "1 4 7 8 1 7 V".

The difference in this submission is:

- To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been
established".

The device remains no change in product design and the additional claim 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 Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 21 CFR 800.20.

## 6.0 Intended Use of the Device:

The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim 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.

# 7.0 Summary of Technological Characteristics for the Modified Device:

The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2<br>FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets<br>< 2 mg/glove |
| Protein Level | ASTM D 5712-95 | < 50 µg/g |

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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 white inside of a black oval. To the right of the logo is the company name in black text. Below the company name is the number 147817V.

# 8.0 Conclusion:

The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim 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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

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

Re: K030157

Trade/Device Name: Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 14, 2003 Received: January 16, 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 vour 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 vours.

Susan Dunne

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 letters "WRP" in white against a black oval background. The letters are large and bold, taking up most of the space within the oval. The font appears to be sans-serif. The overall design is simple and high-contrast.

WRP Asia Pacific Sdn Bhd

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# INDICATIONS FOR USE

Applicant:

510(k) Number (if known):

Device Name:

WRP Asia Pacific Sdn Bhd

K030157

FREE POWDER EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAM ORLESS

Indications For Use:

The Powder Free Latex Examination Gloves, Sterile 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(301.105)

OR Over-The-Counter

St.B. for Clin

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number 110-3015

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