BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

K062527 · Multisafe Sdn. Bhd. · LYY · Feb 20, 2007 · General Hospital

Device Facts

• Record ID: K062527
• Device Name: BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
• Applicant: Multisafe Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.

Device Story

Blue Powder Free Latex Examination Glove is a non-sterile, disposable medical device; manufactured from natural rubber latex compound. Worn on hands by healthcare personnel; serves as a protective barrier against infectious materials, bodily fluids, waste, and environmental contaminants. Device provides physical separation between clinician and patient; reduces risk of cross-contamination. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only. Device meets ASTM D 3578-01 standards and FDA requirements. Biocompatibility testing included primary dermal irritation and dermal sensitization studies, which the device passed.

Technological Characteristics

Material: Natural rubber latex compound. Form factor: Disposable examination glove. Standards: ASTM D 3578-01, ISO 11193, EN 455 (Parts 1, 2, 3). Non-sterile. No energy source, connectivity, or software.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable barrier against infectious materials and contamination. No specific age or gender restrictions.

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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### 17.0 SMDA 510(K) SUMMARY

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K062527

# FEB 2 0 2007

| 1. Applicant | MULTISAFE SDN. BHD<br>Lot 764, Bidor Industrial Estates,<br>35500 Bidor,<br>Perak Darul Ridzuan,<br>Malaysia. |
|--------------------------|---------------------------------------------------------------------------------------------------------------|
| Tel No. | 605-4348269 |
| Fax No | 605-4348266 |
| Name of Contact Person | 1. Mr. Abd Hadi bin Husin<br>2. Ms. Rosnani Binti Hassan Besari |
| Date of Summary Prepared | 10th August 2006 |
| 2. Name of Device | |
| Trade Name | Blue Powder Free Latex Examination<br>Glove, Non-Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class 1 in<br>US and European markets, Class IIa in<br>Canadian Market) |

## 3. Identification Of the Legally Marketed Devices

Latex Patient Examination Gloves LYY, Powder Free that meets all the requirements of FDA, ASTM D 3578, ISO 11193, EN 455 : Part 1, Part 2 and Part 3, CMDR, MDR and CGSB.

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### Description Of the Devices 4.

K062527

Latex Patient Examination Gloves, LYY, Powder Free

### 5. The Intended Use of Glove

A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.

- The Quality performance of the glove are shown in the table above 6. meets ASTM D 3578-01 Standard and FDA's requirement
- 7. The Biocompatibility Test consists of Primary Dermal Irritation Study And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.

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# Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2007

Mr. Abd Hadi Bin Husin Plant Manager MultiSafe Sdn. Bhd. Lot 764, Bidor Industrial Estate, 35500 Bidor, Perak MALAYSIA

Re: K062527

Trade/Device Name: Blue Powder Free Latex Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 15, 2007 Received: January 26, 2007

Dear Mr. Husin:

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 your 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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Page 2 - Mr. Husin

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Ching-Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

# Enclosure

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Applicant :

MULTISAFE SDN. BHD Lot 764, Bidor Industrial Estate, 35500 Bidor, Perak, Malaysia.

Tel No : 605-4348269 Fax No : 605-4348266

510(k) Number (if known) :

KOG2527

Device Name : Blue Powder Free Latex Examination Gloves, Non-Sterile

Indication for Use :

Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.

Prescription Use (Part 21 CFR 801 Subpart D)

# AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 -

Elaine S. Mayhall for S. Murphy

062527