POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB

K030112 · Pt. Smartglove Indonesia · LYY · Feb 27, 2003 · General Hospital

Device Facts

• Record ID: K030112
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB
• Applicant: Pt. Smartglove Indonesia
• Product Code: LYY · General Hospital
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable latex examination gloves; worn on examiner's hands; function as physical barrier to prevent cross-contamination between patient and examiner; available in creamy white and blue colors; features protein labeling claim of 50 micrograms or less of total water extractable protein per gram of glove; intended for use in clinical or medical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex; Type: Powder-free examination glove; Colors: Creamy white and blue; Protein content: 50 micrograms or less of total water extractable protein per gram of glove; Regulation: 21 CFR 880.6250; Product Code: LYY.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

Mr. Foo Khon Pu Managing Director PT. Smart Glove Indonesia Jl. Pelita Raya No. 5-7 Kawasan Industri Medan Star Jl. Raya Medan-Lubuk Pakam Km. 19, Tg Morawa B- Tg. Marowa Deli Serdang, 20362 Sumatera Utara, INDONESIA

## Re: K030112

Trade/Device Name: Powder Free Latex Examination Gloves with Protein Labeling Claim of 50 Micrograms or Less of total Water Extractable Protein Per Gram of Gloves with Creamy White and Blue Colors Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 6, 2003 Received: January 13, 2003

Dear Mr. Khon Pu:

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 mav, 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. Khon Pu

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 (OS) 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 Runor

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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## GLOVE INDONESIA

Page 3 of 4€

## 3.0 Indication for Use Statement:

## INDICATION FOR USE

| Applicant: | PT.SMART GLOVE INDONESIA |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | Applied for K030112 |
| Device Name: | Powder Free Latex Examination Gloves with protein labeling claim less than of 50 microgram or less of total water extractable protein per gram of gloves. with creamy (white) and blue colors. |
| Indication For Use: | |

Indication For Use:

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Clis S. Lim

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K030112

Prescription Use Per 21 CFR 801.109 OR Over-The-Counter (Optional Format 1-2-96)

J1. Pelita Raya No. 5 -7 Kawasan Industri Medan Star J1. Raya Medan - Lubuk Pakam Km. 19, Tg Marowa B - Tg. Marowa Deli Serdang - 20362 Sumatera Utara - Indonesia. Tel : [phone] Fax : [phone]