VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR

K031944 · Arista Latindo Industrial Ltd. P.T · LZA · Sep 23, 2003 · General Hospital

Device Facts

• Record ID: K031944
• Device Name: VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
• Applicant: Arista Latindo Industrial Ltd. P.T
• Product Code: LZA · General Hospital
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Vinyl examination gloves; disposable; worn by healthcare providers during patient examinations; function as protective barrier to prevent cross-contamination between examiner and patient; pink color; powder-free; intended for medical use.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Vinyl material; powder-free; pink color; disposable; Class I patient examination glove; Regulation 880.6250; Product Code LZA.

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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Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linga Sumarta Arista Latindo Industrial, Limited P.T. JL: K.H.MOH Mansyur No 128 Jakarta 11210 INDONESIA

Re: K031944

Trade/Device Name: Vinyl Examination Gloves Powder Free Pink Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 23, 2003 Received: August 28, 2003

Dear Ms. Sumarta:

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 -Ms. Sumarta

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/dsma/dsmamain.html

Sincerely vours.

Susan Runner

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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## Section No. 3.

## ATTACHMENT #2

## INDICATIONS FOR USE STATEMENT

| Applicant: | PT. ARISTA LATINDO IND. LTD. |
|---------------------------|---------------------------------------------------|
| 510(k) Number (if known): | K031944 * |
| Device Name: | Vinyl Examination Gloves, Powder Free, Pink Color |
| Indications For Use: | |

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031944

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Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use. Per 21 CFR 801.109 OR

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

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