POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2

K013443 · Maxter Glove Manufacturing Sdn Bhd · LYY · Nov 29, 2001 · General Hospital

Device Facts

• Record ID: K013443
• Device Name: POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
• Applicant: Maxter Glove Manufacturing Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Nov 29, 2001
• 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

Powdered latex medical examination glove; worn on hand by healthcare personnel; acts as protective barrier to prevent cross-contamination between clinician and patient; intended for use in clinical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Powdered latex material; contains 150 micrograms or less of total water-extractable protein per gram of glove; Class I medical device.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier on the hand 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 2 9 2001

Mr. Stanley Thai Managing Director Maxter Glove Manufacturing Sdn Bhd Lot 607, Jalan Haji Abdul Manan 41050 Klang, Selangor, MALAYSIA

Re: K013443

Trade/Device Name: Powdered Latex Medical Examination Gloves with 150 Microgram Or Less of Total Water Extractable Protein per Gram of Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 15, 2001 Received: October 17, 2001

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 (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. Thai

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA \$ Issuance of a substitions with other requirements
mean that FDA has made a determination that your device with other Federal agencies. mean that FDA nas made a decemination that your administered by other Federal agencies.
of the Act or any Federal statutes and regulations abut not limited to: registration of the Act or any Federal statues and registered to the limited to: registration
You must comply with all the Act step of any and each annoufacturing practice You must comply with an the Act 3 requirements, interesting of the manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practi and listing (21 CFR Part 807), labeling (21 CFR (21 corrision (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Parts) requirements as set forth in the quality systems (Sections (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 This letter will allow you to begin marketing your substantial equivalence of your device and thus 510(k) premarket notification. The I DA Intining or documents of your device and thus,
a legally marketed predicate device results in a classification for your device and thu a legarry and device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801
plaase controller in the contraction and answere devices), please contact the If you desire specific advice for your device in vitro diagnostic devices), please contact the and additionally 21 CPR Fall 809.10 Ion in the onalism on the promotion and
Office of Compliance at [phone]. Additionally, for questions of [phone]. Office of Compliance at [phone]: Truditions of Compliance at [phone].
advertising of your device, please contact the Office of Compliance to premarket advertising of your do regulation entitled, "Misbranding by reference to premarket Also, please note the regulation only concernal information on your responsibilities under
notification" (21CFR Part 807.97). Other general informational and notification" (21CFK Part 807.97). Other general Manufacturers, International and the Act may be obtained from the Driviner of the 638-2041 or [phone] or at its
Consumer Assistance at its toll-free number [phone] or (800) Consumer Assistance at its ton-nece hamor (000) es as main html.

Sincerely yours

Alalaturk

Timot Director Division of Dental, Infection Control and General Hospital 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) :________________________________________________________________________________________________________________________________________________ K 013443

Powdered Latex Medical Examination Gloves with 150 Micrograms or Less Device Name : Powdered Latex Modioal Extractable Protein per Gram of Glove.

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.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109) OR

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

Clim Slim

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control
Division of Dental, Infection Devices Division or all Hospital Devic 510(k) Number

(Optional Formal 1-2-96)