SUPERGLOVES POWDERED NITRILE

K980966 · Supermax Sdn Bhd · LZA · Jul 22, 1998 · General Hospital

Device Facts

• Record ID: K980966
• Device Name: SUPERGLOVES POWDERED NITRILE
• Applicant: Supermax Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jul 22, 1998
• 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 nitrile examination glove; worn on hands of healthcare or similar personnel; acts as physical barrier to prevent cross-contamination between wearer and patient; used in clinical or similar settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powdered; examination glove form factor; Class I device; non-sterile (implied by examination glove classification).

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier to prevent cross-contamination between the wearer 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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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

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## JUL 22 1998

Mr. Stanley Thai Managing Director Supermax Glove Manufacturing Sdn. Bhd. Lot 42, Putra Industrial Park, Bukit Rahman Putra 47000 Sungai Buloh Selangor Darul Ehsan, MALAYSIA

Re : K980966 Powdered Nitrile Examination Gloveš Trade Name: Requlatory Class: I Product Code: LZA Dated: May 27, 1998 June 3, 1998 Received:

Dear Mr. Thai:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Thai

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutrow for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure ...

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Indications for Use Statement : Include the following or equivalent Indications for Use page. 3.0 The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

## INDICATIONS FOR USE

Supermax Glove Manufacturing Sdn Bhd Applicant :

Powdered Nitrile Examination Gloves

Indications For Use :

Device Name :

510(k) Number (if known) :

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.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter X

*

(Optional Format 1-2-96)

* For a new submission, do NOT fill in the 510(k) number blank,