DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE

K021396 · Wrp Specialty Products Sdn. Bhd. · LZA · May 16, 2002 · General Hospital

Device Facts

• Record ID: K021396
• Device Name: DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The 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.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; worn by healthcare examiners on hands or fingers. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Provides protection for both patient and clinician during medical examinations.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including dimensions, physical properties, freedom from pinholes, powder-free residue levels, and biocompatibility (primary skin irritation and dermal sensitization).

Technological Characteristics

Nitrile material; powder-free (< 2 mg/glove). Meets ASTM D 6319-00a (dimensions, physical properties, pinholes) and ASTM D 6124-01 (powder residue). Biocompatible (non-irritant, non-sensitizer). Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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.

Submission Summary (Full Text)

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MAY 1 6 2002

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'KQ21396'. The characters are written in a cursive style, with some connections between them. The overall impression is that of a handwritten code or identifier.

## 510(k) Summary

#### 1.0 Submitter:

| Name: | WRP Specialty Products Sdn Bhd. |
|------------|--------------------------------------------------------------------------------------------------------------|
| Address: | Lot 11, Jalan 2, Kawasan Perushaan Bandar Baru Salak<br>Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 30 APR 2002

### 2.0 Contact Person:

| Name: | V. Nadarajan |
|------------|-----------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

## 3.0 Name of the device:

| Proprietary or Trade Name: | 1) Dermagrip, and |
|----------------------------|------------------------------------------------------------|
| | 2) Multiple or Customer's Trade Name |
| Classification Name : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name : | Powder Free Purple Nitrile Examination Gloves, Non-Sterile |

## Identification of The Legally Marketed Device: 4.0

Class I patient examination gloves, 80LZA, powder free, that meets all the
requirements of ASTM standard D 6319 - 00a" and FDA 21 CFR 800.20.

#### Description of The Device: 5.0

The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.

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#### Intended Use of the Device: 6.0

The patient examination glove is a disposable device intended for medical purposes The pation on the examiner's hand or finger to prevent contamination between patient and examiner.

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

The Powder Free Purple Nitrile Examination Gloves, Non Sterile is summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standards | Device Performance |
|-----------------------|------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dimensions | ASTM D 6319 – 00aEI | Meets |
| Physical Properties | ASTM D 6319 – 00dEI | Meets |
| Freedom from pinholes | ASTM D 6319 – 00dEI<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 – 01 | < 2 mg/glove |
| Biocompatability | Primary Skin Irritation in Rabbits<br>Dermal Sensitization | Passes<br>(Not a primary skin irritant)<br>Passes<br>(Not a contact sensitizer) |

## 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 Purple Nitrile Examination Gloves, Non Sterile will perform according to the glove performance standards referenced 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 6 2002

Mr. V. Nadarajan Manager, QA/RA Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA

Re: K021396

Trade/Device Name: Dermagrip and Multiple Powder Free Purple Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 30, 2002 Received: May 2, 2002

Dear Mr. V. Nadarajan:

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 (1 mr 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 modifine and read a aves a detes and regulations administered by other Federal agencies. of the For all) - Posterall the Act's requirements, including, but not limited to: registration 1 od into compry That and 1 years 801); good manufacturing practice and fiscing (21 OF rear of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in one of 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 This letter will and in yours begine 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 and additionally in the 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 the revents) existance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runney

f

Timothy A. 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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# INDICATIONS FOR USE

Applicant:

WRP Specialty Products Sdn Bhd

510(k) Number (if known):

K021396

Device Name:

FREE PURPLE NITRILE POWDER EXAMINATION GLOVES, NON STERILE

Indications For Use:

A 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Olen

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KO21396 510(k) Number ________________________________________________________________________________________________________________________________________________________________

OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter

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