DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS

K014288 · Wrp Specialty Products Sdn. Bhd. · KGO · Feb 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014288
• Device Name: DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) are disposable devices intended for medical purposes that is worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable sterile latex surgical glove; polymer-coated; powder-free. Used by surgeons and operating room personnel to provide protective barrier for surgical wounds. Prevents contamination between patient and clinician. Manufactured to meet ASTM D 3577-00 standards for physical properties and pinhole resistance. Protein content labeled at 50 micrograms or less to reduce potential for latex sensitivity. Device is single-use.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including physical property testing, pinhole leak testing per FDA 21 CFR 800.20, powder-free residue testing (ASTM D 6124-97), protein level testing (ASTM D 5712-95), and biocompatibility testing (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Natural rubber latex. Coating: Polymer. Powder-free (< 2 mg/glove). Protein content: < 50 μg/g. Standards: ASTM D 3577-00 (dimensions, physical properties, pinholes), ASTM D 6124-97 (powder), ASTM D 5712-95 (protein). Biocompatibility: Passes primary skin irritation and dermal sensitization tests. Sterilization: Sterile.

Indications for Use

Indicated for use by surgeons and operating room personnel as a protective barrier to prevent surgical wound contamination. No specific age or gender restrictions; contraindications not specified.

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.

Submission Summary (Full Text)

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### 510(k) Summary

K014288

### Submitter: 1.0

# FEB 1 3 2002

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

Date of Summary Prepared : 1st August, 2001

#### 2.0 Contact Person:

| Name: | Mr. Mohd Haizan Hussein |
|-------------|-------------------------|
| Phone No .: | [phone] |
| Fax No .: | [phone] |

#### 3.0 Name of the device:

| Trade Name | : Powder Free Polymer Coated Latex Surgical Glove,<br>Sterile with Protein Content Labeling (50 micrograms or<br>less) |
|---------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Surgeon's Gloves |
| Classification Name | : Surgeon's Gloves |

#### Identification of The Legally Marketed Device: 4.0

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.

#### 5.0 Description of The Device:

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.

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#### 6.0 Intended Use of the Device:

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) are disposable devices intended for medical purposes that is worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

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

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standards | Device Performance |
|-----------------------|---------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 00 | Meets |
| Physical Properties | ASTM D 3577 - 00 | Meets |
| Freedom from pinholes | ASTM D 3577 - 00<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 97 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 95 | < 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) |

#### 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 Dermagrip Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (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 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 features a stylized depiction of an eagle or bird with three horizontal lines extending from its body, suggesting wings or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 3 2002

Mr. Mohd H. Hussein Manager WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor, Darul Ehsan, MALAYSIA

## Re: K014288

Trade/Device Name: Dermagrip Powder Free Polymer Coated Latex Surgeon's Gloves, Sterile with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: December 13, 2001 Received: December 28, 2001

### Dear Ms. Hussein:

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 vour 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,

Timoth 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): | | | | |
| Device Name: | | POWDER FREE POLYMER COATED LATE | | |

## POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE, STERILE WITH PROTEIN CONTENT LABELING (50 MICROGRAMS OR LESS)

Indications For Use:

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) is a disposable device intended for medical purposes that is worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter

Elin S. lin

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