MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES

K040176 · Maxter Glove Manufacturing Sdn Bhd · LZA · Feb 24, 2004 · General Hospital

Device Facts

• Record ID: K040176
• Device Name: MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
• Applicant: Maxter Glove Manufacturing Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Feb 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Maxter Powder Free Nitrile Medical Examination Gloves are disposable, non-sterile gloves designed for use by healthcare and similar personnel. The device acts as a physical barrier to prevent cross-contamination between the wearer and the patient. Used in clinical and general healthcare settings, the gloves are donned by the operator to protect both parties during examinations or procedures. The device is a standard personal protective equipment (PPE) item; it does not involve electronic inputs, algorithms, or software. Benefit is derived from the nitrile material's barrier properties, providing protection against contaminants.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; disposable; non-sterile; form factor is a hand-worn glove; no electronic components or software.

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the user and the patient.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Mr. Stanley Thai Managing Director Maxter Glove Manufacturing Sdn Bhd Lot 6070, Jalan Haji Abdul Manan, 611 Miles Off Jalan Meru, 41050 Klang, Selangor MALAYSIA

Re: K040176

Trade/Device Name: Maxter Powder Free Nitrile Medical Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: January 9, 2004 Received: January 26, 2004

Dear Mr. Thai:

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 (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 12 ) 1 ) 1 ( 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 , 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. Thai

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,

Carls

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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## INDICATIONS FOR USE

| Applicant : | Maxter Glove Manufacturing Sdn. Bhd. - |
|-----------------------------|-------------------------------------------------------|
| 510 (k) Number (if known) : | K040176 |
| Device Name : | MAXTER Powder Free Nitrile Medical Examination Gloves |

Indications For Use :

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susanne F. Bassett

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

510(k) Number: K040176

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