DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI

K040645 · Wrp Asia Pacific Sdn. Bhd. · LYY · Apr 28, 2004 · General Hospital

Device Facts

• Record ID: K040645
• Device Name: DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Apr 28, 2004
• 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 hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Device Story

Disposable latex examination glove; green color; coated with Aloe Vera. Worn by healthcare professionals on hands or fingers during patient examinations. Acts as a protective barrier to prevent cross-contamination between patient and examiner. Intended for single use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Latex. Features: Aloe Vera coating, green color. Protein content: 50 micrograms or less water extractable protein. Form factor: Disposable glove. Regulatory class: I. Product code: LYY.

Indications for Use

Indicated for use as a disposable patient examination glove to prevent contamination between patient and examiner. Suitable for general medical use.

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

## APR 2 8 2004

Mr. Terence Lim Associate Manager, Quality Assurance Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan MALAYSIA

Re: K040645

Trade/Device Name: Dermagrip-G and Multiple Customers Trade name Green Color, Aloe Vera Coated Latex Examination Gloves With Proteen Content Labeling Claim (50 Micrograms or Less Water Extractable Protein) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 9, 2004 Received: March 11, 2004

Dear Mr. Lim:

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. Lim

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 yours,

Chia-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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WRP Asia Pacific Sdn Bhd

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## Indications for Use

310(k) Number (if known).

Devise Name - DERMAGRIP-G AND MULTIPLE CUSTOMER TRADE NAME GREEN COLOR, ALOE VERA COATED, LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (\$0 MICROGRAMS OR LESS WATER EXTRACTABLE PROTEIN)

traications For Use

A patient examination glove is a disposable device intended for mediest proposes that is worn ut The examiner's hands or firstar to prevent continuition beliveren patient and exadion. (21CFR 880 6250)

Preseription Use (Pro 21 CFR 80) Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subgari (8).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANUTHER PAGE IP NEEDED

Concertifica of CDRH, Office of Device Evidention (ODE)

2. And 11:10:00 PM IST 11:00 PM IS 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM IST 11:00 PM

Kevin Mulvey

(Division Sign-Off) Division of Anesthesiology, General Hosp tion Control, Dental Devices

510(k) Number: K040645

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