POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)

K974183 · Sri Johani Sdn. Bhd. · LZA · Dec 18, 1997 · General Hospital

Device Facts

• Record ID: K974183
• Device Name: POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
• Applicant: Sri Johani Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 18, 1997
• 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Powder-free blue nitrile examination glove; polymer coated. Disposable device worn on examiner's hand or finger. Used in clinical settings to provide a protective barrier against contamination between patient and examiner. Operates as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile material; powder-free; polymer coated. Disposable form factor. Class I device. No energy source or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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

DEC 18 1997

Mr. Lim Lee Aik Managing Director SRI Johani Sdn. Bhd. Lot PT 7178, Balakong N/V, 43300 Seri Kembangan Selangor Darul Malaysia

Re : K974183 Powderfree Blue Nitrile Examination Gloves Trade Name: (Polymer Coated) Requlatory Class: I Product Code: LZA Dated: October 17, 1997 Received: November 6, 1997

Dear Mr. Lee Aik:

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 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). 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 (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. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Paqe 2 - Mr. Lee Aik

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 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 leqally 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.fdp.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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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Attachment 7

## 510(k) number(if known): _K_974183

Device Name: Pouderfree Blue Nitrile Examination Gloves Polymer Coated

Indications For Use:

A Patient Examination Glove is a disposable device intended
finger, to Cornedical purpose that is worn on the examiner's hand or
finger to prevent contamination between and finger contamination examiner. between patient and

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Clun 3. Lin

(Division Sign Off) Division of Dental, Infection Control and General Hospital 510(k) Number

Prescription Use er 21 CFR 801-109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)