CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE

K031021 · Perusahaan Getah Asas Sdn. Bhd. · LYY · Jun 13, 2003 · General Hospital

Device Facts

• Record ID: K031021
• Device Name: CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 13, 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Polymer-coated, powder-free latex patient examination glove; designed for use by healthcare professionals during patient examinations; acts as a physical barrier to prevent cross-contamination between examiner and patient; contains 50 micrograms or less of total water extractable protein per gram to reduce potential for latex protein sensitization; disposable; single-use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex; polymer-coated; powder-free; protein content ≤ 50 micrograms/gram; Class I device; Regulation 880.6250; Product Code LYY.

Indications for Use

Indicated for use as a disposable medical glove 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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three parallel lines forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

JUN 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Perusahaan Getah Asas Sdn Bhd C/O Mr. James F. Logan Director General Medical Reports Exchange, Incorporated 1301 Defence Highway Gambrills, Maryland 21034

Re: K031021

Trade/Device Name: Polymer Coated, Powder-Free Latex Examination Gloves (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: March 28, 2003 Received: March 31, 2003

Dear Mr. Logan:

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. Logan

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 Runos

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 3, Rev 2

Page 1 of 1

510 (K) Number (if known) : K 031021

Device Name

: Polymer-Coated, Powder-free, Latcx Patient Examination Glove with Protein Labelling Claim (contain 50 microgram or less of total water extractable protein per gram)

Indications For Use

A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Pcr 21 CFR 801.109) | |

OR

Over-The-Counter Use

( Optional Formal 1-2-96 )

Qim S. Lim

(Division Sign-Off) n of Anesthesiology, General Hospital, n Control, Dent

510(k) Number: K031002