HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES

K981893 · M.R.G. Industries Sdn. Bhd. · LYY · Jun 22, 1998 · General Hospital

Device Facts

• Record ID: K981893
• Device Name: HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
• Applicant: M.R.G. Industries Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

HEALTH + AID® PREMIUM Pre-powdered Latex 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.

Device Story

Single-use latex examination glove; worn on hands of healthcare personnel; acts as physical barrier to prevent cross-contamination between clinician and patient; manufactured from natural rubber compound; pre-powdered; intended for clinical/medical settings.

Clinical Evidence

No clinical tests were conducted. Nonclinical laboratory and animal data provided. Biocompatibility testing included primary skin irritation in rabbits and delayed contact sensitization in guinea pigs, showing no irritation or sensitization. Bench testing confirmed compliance with ASTM D 3578-95 specifications.

Technological Characteristics

Natural rubber latex compound; pre-powdered; single-use; dimensions and physical properties conform to ASTM D 3578-95; protein content limited to 100mcg/gm or less.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use protective barrier to prevent cross-contamination between personnel and patients. Product features a protein label claim of 100mcg/gm or less total water extractable protein per gram.

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 Pre-powdered Latex Examination Gloves (Class 1 patient examination glove 80LYY)

Submission Summary (Full Text)

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## 510(k) SUMMARY

## HEALTH + AID® PREMIUM PRE-POWDERED FRÉE LATEX 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 5555 |
| Submitter 's Fax Number : | 605 891 2688 |
| Name of Contact Person : | Goh, See Khek |
| Date of Preparation : | May 23, 1998 |
| Name of Device : | |
| Trade Name : | HEALTH + AID® PREMIUM PRE-POWDERED<br>LATEX EXAMINATION GLOVES |
| Common Name : | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which<br>Equivalency is Being Claimed : | HEALTH + AID® PREMIUM Pre-powdered<br>Latex Examination Gloves as described in the<br>510(k) notification are substantially equivalent to<br>the Class 1 patient examination glove 80LYY. It<br>meets all the current specifications listed under<br>the ASTM Specification D 3578 - 95, Standard<br>Specification for Rubber Examination Gloves. |
| Description of the Device : | HEALTH + AID® PREMIUM Pre-powdered<br>Latex Examination Gloves meet the current<br>specifications listed under the ASTM<br>Specification D 3578 - 95, Standard Specification<br>for Rubber Examination Gloves. They are |
| Intended Use of the Device: | HEALTH + AID® PREMIUM Pre-powdered<br>Latex Examination Gloves are intended for single<br>use for medical purposes and are worn on the<br>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 are no different technological<br>characteristics. Gloves are made from natural<br>rubber compound and the initial products are<br>powdered natural latex examination gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95<br>and 21 CFR 800.20. Gloves meet all the current<br>specifications listed under the ASTM<br>Specification D 3578 - 95, Standard Specification<br>for Rubber Examination Gloves.<br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the guinea<br>pig indicate no irritation or sensitization. |
| 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. |
| Other Information Deemed Necessary by<br>FDA : | Not applicable |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 22 1998

Mr. See Khek Goh ·M.R.G. Industries Sdn. Bhd. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA

Re : K981893 Health + Aid® Pre-Powdered Latex Trade Name: Examination Gloves with 100 mcgm or Less Total Water Extractable Protein Regulatory Class: I Product Code: LYY Dated: May 29, 1998 Received: May 29, 1998

Dear Mr. See Khek Goh:

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) 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 addition, FDA may publish further announcements concerning your device in 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

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Page 2 - Mr. See Khek Goh

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 described in your sie in promalence of your device to a legally marketed predicate device results in a classification for your marketed predicate actros 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.fday.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 Radioloqical Health

Enclosure

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Attachment 2

## INDICATIONS FOR USE

| Applicant | : | M.R.G. INDUSTRIES SDN. BHD.<br>PT 4004, Kamunting Industrial Estate<br>P.O. Box 9<br>34600 Taiping Perak<br>MALAYSIA |
|-----------------------------|---|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number<br>(if known) | : | K981893 * |
| Device Name | : | HEALTH + AID® PREMIUM PRE-POWDERED LATEX<br>EXAMINATION GLOVE (PROTEIN LABEL CLAIM) |
| Indications For Use | : | 100mcg/gm or less total water extractable<br>protein per gram |
| | | HEALTH + AID® PREMIUM Pre-powdered Latex 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)

Chris S.
(Division Sign-Off)

( Division of Dental, Infection Control,
and General Hospital, Infection Control, and General Hospital, Infection -510(k) Number

Over-The-Counter OR

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