HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

K991304 · M.R.G. Industries Sdn. Bhd. · LZA · Jun 23, 1999 · General Hospital

Device Facts

• Record ID: K991304
• Device Name: HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
• Applicant: M.R.G. Industries Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

HEALTH AID ® PREMIUM Powder Free Nitrile Examination Gloves are intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.

Device Story

Nitrile examination gloves; single-use; worn by healthcare personnel. Function as protective barrier to prevent cross-contamination between clinician and patient. Manufactured from nitrile rubber compound; processed via washing and surface chlorination to achieve powder-free state. Available in blue or natural white. Used in clinical settings; non-sterile. Provides physical barrier protection.

Clinical Evidence

No clinical tests conducted. Non-clinical evidence includes bench testing per ASTM D 3578-95 and 21 CFR 800.20. Biocompatibility testing (primary skin irritation in rabbits and delayed contact sensitization in guinea pigs) showed no irritation or sensitization. USP iodine test confirmed absence of starch.

Technological Characteristics

Material: Nitrile rubber compound. Form: Powder-free examination glove. Processing: Washing and surface chlorination. Standards: ASTM D 3578-95. Biocompatibility: Tested for skin irritation and sensitization.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use protective barrier worn on the hands to prevent cross-contamination between personnel and patients.

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

• HEALTH + AID® PREMIUM Powder Free Nitrile Examination Gloves (K991304)

Submission Summary (Full Text)

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## 510(k) SUMMARY

JUN 2:3 1999

## HEALTH + AID® PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES

| Submitter's Name : | M.R.G.Industries Sdn. Bhd. |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address : | PT 4004, Kamunting Industrial Estate<br>34600 Taiping Perak<br>Malaysia |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number : | 605 891 1088 |
| Name of Contact Person : | Lim, Chong Eng |
| Date of Preparation : | May 15,1999 |
| Name of Device : | |
| Trade Name : | HEALTH + AID® PREMIUM POWDER FREE<br>NITRILE EXAMINATION GLOVES |
| Common Name : | Nitrile examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which<br>Equivalency is Being Claimed : | HEALTH + AID® PREMIUM Powder Free<br>Nitrile Examination Gloves as described in the<br>510(k) notification are substantially equivalent to<br>the Class 1 patient examination glove (Nitrile)<br>80LZA, that meets all the current specifications<br>listed under the ASTM Specification D 3578 -<br>95, Standard Specification for Rubber<br>Examination Gloves, EXCEPT for ultimate<br>elongation before ageing.. |
| Description of the Device : | HEALTH + AID® PREMIUM Powder Free<br>Nitrile Examination Gloves meet all the current<br>specification listed under the ASTM Specification |
| | Examination Gloves, EXCEPT for ultimate<br>elongation before ageing. They are blue or<br>natural white in colour and are powder free. |
| Intended Use of the Device: | HEALTH AID ® PREMIUM Powder Free<br>Nitrile Examination Gloves are intended for<br>single use for medical purposes that is worn on<br>the hand of health care and similar personnel to<br>prevent contamination between the health care<br>personnel and the patients. |
| Summary of Technological<br>Characteristics Compared to the Predicate<br>Device : | There is no different technological characteristics.<br>Gloves are made from nitrile rubber compound<br>and the initial products are powdered nitrile<br>rubber gloves. These gloves are then further<br>processed into powder free gloves using the<br>existing technology, i.e. washing and then<br>chlorinating the surfaces of the gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95<br>and 21 CFR 800.20. Gloves meet the current<br>ASTM D 3578 - 95 Standard Specification for<br>Rubber Examination Gloves, EXCEPT for<br>ultimate elongation before ageing.<br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the guinea<br>pig indicate no irritation or sensitization.<br>Final product is negative for the presence of<br>starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this<br>510(k). |
| Conclusions Drawn for the Nonclinical<br>and Clinical Tests : | Nonclinical laboratory and animal data indicate<br>that the powder free product meets all<br>performance and biocompatability requirements. |

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| Other Information Deemed Necessary by FDA : | Not applicable |
|---------------------------------------------|----------------|
|---------------------------------------------|----------------|

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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 stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 23 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chong Eng Lim General Manager M.R.G. Industries Sdn. Bhd. PT4004, Kamunting Industrial Estate P.O. Box 9, 34600 Kamuntinq Taiping, Perak MALAYSIA

Re: K991304 Health + Aid® Premium Powder Free Blue Trade Name: Nitrile Examination Gloves Requlatory Class: 】 Product Code: LZA Dated: April 3, 1999 Received: April 16, 1999

Dear Mr. Chonq Eng Lim:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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

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Page 2 - Mr. Chong Eng Lim

this response to your premarket notification Please note: 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 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.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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## INDICATIONS FOR USE

Applicant

:

:

M.R.G. INDUSTRIES SDN. BHD. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA

K991304 *

510(k) Number (if known)

Device Name

HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

Indications For Use

HEALTH + AID PREMIUM Powderfree Nitrike Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

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Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use<br>Per 21 CFR 801.109 | |
|------------------------------------------------------------------------|-----------------------|
| OR | Over-The-Counter<br>X |
| (Division Sign-Off) | |
| Division of Dental, Infection Control,<br>and General Hospital Devices | |