SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES

K993258 · Supermax Sdn Bhd · LZA · Oct 27, 1999 · General Hospital

Device Facts

• Record ID: K993258
• Device Name: SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
• Applicant: Supermax Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

Device Story

Device is a disposable, powder-free nitrile examination glove. Used by healthcare personnel in clinical settings to provide a protective barrier against infectious materials and contaminants. Functions as a physical barrier worn on hands or fingers. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Nitrile (synthetic rubber). Form factor: Disposable examination glove. Powder-free. Non-sterile. No energy source or software.

Indications for Use

Indicated for use as a disposable, synthetic, powder-free patient examination glove worn on the hand or fingers by healthcare personnel to provide a barrier against infectious materials and contaminants.

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

OCT 2 7 1999

Mr. Stanley Thai Managing Director Managing Director
Supermax Glove Manufacturing Sdn. Bhd. Lot 42, Pultra Industrial Park Bukit Rahman Putra 47000 Sungai Buloh 47666 Bangar Darul Ehsan, Malaysia

Re: K993258

> Powder Free Nitrile Examination Gloves Trade Name: Regulatory Class: I Product Code: LZA Dated: September 25, 1999 Received: September 29, 1999

Dear Mr. Thai:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceion becamed we have determined the market the nevice fereiched above (for the indications for device is substancially cquivated (is success marketed in interstate use stated in the encrosure, co te enactment date of the commerce prior co nay be, or to devices that have been Medical Device Amendices, with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, Food, Drug, and Cosmetic nee (1.00, .
market the device, subject to the general controls provisions market the device, Babject to says of the Act of the Act. The general onnual registration, listing of Include requiremufacturing practice, labeling, and devices, good manabass misbranding and adulteration.

If your device is classified (see above) into cither class II II your device Is childred (bod we market Approval), it may (Special Controls) or Stilling Controls. Existing major be subject to sach address device can be found in the Code of regulations arrecting forms 21, Parts 800 to 895. A Rederal Regulations, frere try ination assumes compliance with substancially equivalent actice for Medical Devices: General the Good Manufacturing Praoch 820) and that, through periodic (GMP) Legulation (2) erk Fard Drug Administration (FDA) will GMF Inspections) choons. Failure to comply with the GMP vertify such abbumpelons. regulatory action. In addition, FDA regulation may resure in the ments concerning your device in

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Page 2 - Mr. Thai

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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## 510 (k) NUMBER (if KNOWN) : K 993258

## DEVICE NAME : POWDER FREE NITRILE EXAMINATION GLOVES

INDICATIONS FOR USE :

A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use , (per 21 CFR 801.109)

Over-The-Counter- Use ાર (Optional Format 1-2-96)

Elaine Silin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number .