COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE

K993313 · Wrp Asia Pacific Sdn. Bhd. · LZA · Nov 23, 1999 · General Hospital

Device Facts

• Record ID: K993313
• Device Name: COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 23, 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

Disposable sterile nitrile patient examination glove; worn by healthcare personnel to prevent cross-contamination between examiner and patient/environment. Device acts as physical barrier; protects against fluids and waste. Used in clinical settings; operated by healthcare professionals. Provides protection during patient examinations; reduces risk of infection transmission.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D 3578-99 for tensile strength and FDA 1000 ml watertight test (G-I, AQL 2.5). Physical properties before aging: 25.01 MPa tensile strength, 674% elongation. After aging: 25.32 MPa tensile strength, 649% elongation. Residual powder content < 2mg/glove.

Technological Characteristics

Nitrile rubber material; powder-free; sterile. Dimensions: XS-L sizes (220-248mm length). Single wall thickness: 0.19mm (finger), 0.13mm (palm). Meets ASTM D 3578-99 standards for tensile strength and watertight integrity.

Indications for Use

Indicated for use as a disposable medical device 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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WRP Asia Pacific Sdn Bhd

K93313

NOV 2 3 1999

BER PRODUCTS (M) SON BHD

ATTACHMENT 3 (Revised)

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

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

CONTACT PERSON : Y. W. CHOW

# 510(k) SUMMARY

- 1. Trade Name COMFIT POWDER FREE BLUE NITRILE EXAMNATION : GLOVE, STERILE
- 2. Common Name Examination Gloves :
- Patient Examination Glove 3. Classification Name :

## 4. Substantial Equivalence :

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

# 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 D 3578-99 | COMFIT Powder Free Blue Nitrile Examination Glove, Sterile - refer to Attachment 8 of Device Test Report of Compliance |
|----------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | G-I, 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)<br>Size | XS min 220<br>S min 220<br>M min 230<br>L min 230<br>XL - | -<br>248<br>245<br>245<br>- |
| 3. Palm Width (mm)<br>Size | XS 70 ± 10<br>S 80 ± 10<br>M 95 ± 10<br>L 111 ± 10<br>XL - | -<br>84<br>94<br>106<br>- |
| 4. Single Wall Thickness<br>(mm)<br>Finger<br>Palm | min 0.08<br>min 0.08 | 0.19<br>0.13 |
| TEST | ASTM<br>D 3578-99 | COMFIT Powder Free Blue<br>Nitrile Examination Glove,<br>Sterile - refer to Attachment 8 of<br>Device Test Report of<br>Compliance |
| 1. Physical Properties | | |
| Before Aging : | | |

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5. Physica

Tensile Strength (MPa)

Ultimate Elongation (%)

Tensile Strength (MPa)

Ultimate Elongation (%)

After Aging :

6. Residual Powder

BRODUCTS (M) SDN BHD

25.01

674

25.32

649

Less than 2mg/glove

min 14.0

min 700

min 14.0

min 500

Less than

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# 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 requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test.

### 8. Conclusion

Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification 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 fro tensile strength.

Date Summary Prepared : September 22, 1999. (Amended on November 1, 1999)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1999

Mr. Yue Wah Chow Head of RA/QA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinqqi 43900 Sepanq Selangor Darul Ehsan, Malaysia

к993313 Re : Powder-Free Blue Nitrile Examination Glove, Trade Name: Sterile Requlatory Class: I Product Code: LZA Dated: September 29, 1999 Received: October 4, 1999

Dear Mr. Chow:

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 requlations 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Chow

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 leqally 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 requlation (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 regulation 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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy R. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## ATTACHMENT 2

# Applicant : WRP Asia Pacific Sdn Bhd

510(k) Number (if known) : 长993313

#### COMFIT POWDER FREE BLUE NITRILE EXAMINATION Device Name : GLOVE, STERILE

#### Indications For Use :

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

R **Over-The-Counter Use**

L. A. Cutath

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 . Onk) Number __