← Product Code [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA) · K032549

# MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES (K032549)

_Matang Mfg. Sdn. Bhd. · LZA · Sep 8, 2003 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K032549

## Device Facts

- **Applicant:** Matang Mfg. Sdn. Bhd.
- **Product Code:** [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA.md)
- **Decision Date:** Sep 8, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

## Device Story

Powder-free polychloroprene patient examination glove; worn on hands of healthcare personnel; acts as physical barrier to prevent cross-contamination between patient and clinician; used in clinical settings; disposable.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Material: Polychloroprene; Type: Powder-free patient examination glove; Class I device.

## Regulatory 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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Public Health Service

ood and Drug Administration Corporate Boulevard ckville MD 20850

SEP - 8 2003

Matang Manufacturing Sdn Bhd C/O Mr. KoK-Kee Hon Official Correspondent & US Agent KoK-Kee Hon 6324 Meeting House Way Alexandria, Virginia 22312-1718

Re: K032549

Trade/Device Name: Powder-Free Polychloroprene Patient Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 15, 2003 Received: August 18, 2003

Dear Mr. Hon:

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. Hon

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Paluxa Cuenitiffex
Susan Brewer, DDS, MA

Susan Runner, DDS, MA Interim 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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## APPENDIX 2

## INDICATIONS FOR USE

## MATANG MANUFACTURING SDN. BHD. Applicant:

K032549 510 (k) Number (If known) :

Powder-Free Polychloroprene Patient Examination Gloves Device Name:

Indications For Use:

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

-----------------------------------------------------------------------------Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ----------------Per 21 CFR 801.109

OR

Over-The-Counter

Clint S. Lis

of Anesthesiology, General Hospital,

510(k) Number. K032569

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