POWDER-FREE PATIENT EXAMINATION GLOVES

K971949 · Tekmedic (M) Sdn Bhd · LYY · Jul 28, 1997 · General Hospital

Device Facts

• Record ID: K971949
• Device Name: POWDER-FREE PATIENT EXAMINATION GLOVES
• Applicant: Tekmedic (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Device is a powder-free latex patient examination glove. Worn on hands by healthcare or similar personnel. Acts as a physical barrier to prevent cross-contamination between the wearer and the patient. Used in clinical or similar settings to maintain hygiene and infection control. No complex processing or electronic components involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Latex. Form factor: Examination glove. Powder-free. Class I device.

Indications for Use

Indicated for use by healthcare 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2002

Tekmedic (M) Sdn Bhd C/O Mr. Kok-Kee Hon 6324 Meeting House Way Alexandria, Virginia 22312-1718

Re: K971949 Trade Name: Powder-Free Latex Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 27, 1997 Received: May 28, 1997

Dear Mr. Hon:

This letter corrects our substantially equivalent letter of July 28, 1997 regarding Mr. Ulatowski's Signature.

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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Page 2 - Mr. Hon

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,

Tim 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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07/23/87 WED 12:17 FAX [phone]Z FDA/ODE/DDIGD

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-----------------------------------------------|
| 510(k) Number (if known): | K971949 |
| Device Name: | Tekmedic Powder-Free LATEX Examination Gloves |
| Indications For Use: | |

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

(Division Sign-Off)

Firston of Dental, Infection C and General Hospita 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)