TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

K013317 · Tekmedic (M) Sdn Bhd · LYY · Dec 17, 2001 · General Hospital

Device Facts

• Record ID: K013317
• Device Name: TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Tekmedic (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 17, 2001
• 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 healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Story

Device is a powder-free latex patient examination glove coated with aloe vera. Used by healthcare personnel to provide a protective barrier on the hands, preventing cross-contamination between the wearer and the patient. Features a protein labeling claim of 50 micrograms or less of total water-extractable protein per gram to reduce potential for latex protein sensitization. Device is a single-use, disposable physical barrier.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Latex. Features: Powder-free, aloe vera coating. Protein content: ≤ 50 micrograms/gram water-extractable protein. Form factor: Patient examination glove. Regulatory class: I. Product code: LYY.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between personnel and patients.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2001

Tekmedic (M) Sdn Bhd C/O Mr. Kok-Kee Hon Official Correspondent Kok-Kee Hon P.O. Box 11112 Alexandria, Virginia 22312-9998

## Re: K013317

Trade/Device Name: Tekmedic Powder-Free Aloe Care Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 2, 2001 Received: October 4, 2001

Dear Mr. Hon:

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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timoth Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image is a black and white logo for Tekmedic. The logo is a circle with horizontal lines at the top and a solid black section at the bottom. The word "tekmedic" is written in a sans-serif font in the middle of the circle.

## APPENDIX 2

## INDICATIONS FOR USE

Tekmedic (M) Sdn. Bhd. Applicant:

KO13317 510 (k) Number (If known):

Device Name:

Tekmedic Powder-Free Latex Patient Examination Gloves with Aloe Vera Coating and Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram

Indications For Use:

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

Concurrence of CDRH Office of Device Evaluation (ODE)

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| Prescription Use -------- | OR | Over-The-Counter |
|---------------------------|----|------------------|
| Per 21 CFR 801.109 | | |

Chin S. Lim
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
్ 10(k) Number