DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE

K990752 · Wrp Specialty Products Sdn. Bhd. · LZA · Oct 18, 1999 · General Hospital

Device Facts

• Record ID: K990752
• Device Name: DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Dermagrip Powder Free Nitrile Examination Glove is a non-sterile, disposable nitrile latex glove. Used by healthcare personnel to provide a barrier against contamination between the examiner and the patient's body, fluids, waste, or environment. Device functions as a physical barrier; performance verified via watertight testing and physical property assessment (tensile strength, elongation).

Clinical Evidence

Bench testing only. Performance data includes 1000ml watertight testing (passing G-I, AQL 2.5 and G-II, AQL 4.0), tensile strength (29.50 MPa before aging, 27.45 MPa after aging), ultimate elongation (670% before aging, 583% after aging), and residual powder levels (<2mg/glove).

Technological Characteristics

Nitrile latex material; powder-free; non-sterile. Dimensions and physical properties comply with ASTM D 3578-99 standards. Physical barrier sensing/actuation principle. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent 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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WRP Specialty Products Sdn Bhd

OCT 18 1999

#### ATTACHMENT 3 (Revised)

Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan,

EL [phone] [phone] URL www.wrpworld.com

MALAYSIA

CONTACT PERSON : C. H. KHOO

ID=[phone]

K990752

#### 510(k) SUMMAR

- DERMAGRIP FREE NITRILE POWDER 1. Trade Name EXAMINATION GLOVE, NON STERILE
- Examination Gloves 2. Common Name :
- 3. Classification Name : Patient Examination Glove
- 4. Substantial Equivalence :

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.

#### 5. Intended Use of Device :

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

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Gloves For All Reasons™

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# 6. Summary of Performance Data

Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test.

| TEST | ASTM<br>D 3578-99 | DERMAGRIP Powder Free<br>Nitrile Examination Glove, Non<br>Sterile - refer to Attachment 8<br>of Device Test Report of<br>Compliance | |
|-------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 1. Watertight (1000 ml) | G-1, AQL 2.5 | Pass based on<br>1) Single Sampling Plan, G-I,<br>AQL 2.5,<br>2) Multiple Sampling Plan, G-II,<br>AQL 4.0 | |
| 2. Length (mm) | | | |
| Size | XS<br>S<br>M<br>L<br>XL | min 220<br>min 220<br>min 230<br>min 230<br>- | -<br>260<br>245<br>248<br>- |
| 3. Palm Width (mm) | | | |
| Size | XS<br>S<br>M<br>L<br>XL | $70 \pm 10$<br>$80 \pm 10$<br>$95 \pm 10$<br>$111 \pm 10$<br>- | -<br>84<br>95<br>104<br>- |
| 4. Single Wall Thickness (mm) | | | |
| Finger | | min 0.08 | 0.21 |
| Palm | | min 0.08 | 0.14 |

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Gloves For All Reasons™

A member of the WRP Group of Companies

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| TEST | ASTM<br>D 3578-99 | DERMAGRIP Powder Free<br>Nitrile Examination Glove,<br>Non Sterile - refer to<br>Attachment 8 of Device Test<br>Report of Compliance |
|-------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 14.0 | 29.50 |
| Ultimate Elongation (%) | min 700 | 670 |
| After Aging : | | |
| Tensile Strength (MPa) | min 14.0 | 27.45 |
| Ultimate Elongation (%) | min 500 | 583 |
| 6. Residual Powder | Less than<br>4mg/glove | Less than 2mg/glove |

#### 7. Substantial Equivalence based on Assessment of Non-Clinical Performance Data

The performance test data of device as shown above indicate that these nitrile gloves meet ASTM D'3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation.

#### 8. Conclusion

Based on the test results, these nitrile gloves meet the requirement of FDA's 1000ml Watertight Test and ASTM D 3578-99 requirement for tensile strength. Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement for tensile strength,

Date Summary Prepared : March 25, 1999 (First amendment on May 24, 1999) (Second amendment on July 20, 1999) (Third amendment on October 7, 1999)

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## Gloves For All Reasons™

of the WRP Broup of Componie

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Public Health Service

OCT 18 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chenq Hean Khoo Sr. Manager, Regulatory/Environmental Management WRP Specialty Products Sdn Bhd Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selanqor Darul Ehsan, Malaysia

Re : K990752 Dermagrip Powder Free Blue Nitrile Trade Name: Examination Glove, Non Sterile Regulatory Class: I Product Code: LZA July 20, 1999 Dated: Received: July 28, 1999

Dear Mr. Khoo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Khoo

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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### ATTACHMENT 2

Applicant : WRP Specialty Products Sdn. Bhd.

K990752 510(k) Number (if known) : : __

DERMAGRIP POWDER FREE NITRILE EXAMINATION Device Name : GLOVE, NON STERILE ( Blue

Indications For Use :

- The patient examination glove is a disposable device intended for 1. 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 Use

Qiin S. him

(Division Sign-Off) Division of Dental, Infection and General Hospita 510(k) Number