GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE

K993793 · Guthrie Medicare Products (Melaka) Sdn Bhd · LYY · Jan 12, 2000 · General Hospital

Device Facts

• Record ID: K993793
• Device Name: GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
• Applicant: Guthrie Medicare Products (Melaka) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.

Device Story

Disposable pre-powdered latex patient examination glove; worn by healthcare examiners on hands or fingers. Primary function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical settings; not for surgical procedures. Device provides physical barrier; no active components or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Disposable glove. Pre-powdered. Non-sterile (implied by examination glove classification).

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. Not indicated for surgical use.

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

JAN 1 2 2000

Guthrie Medicare Products (NS) SDN BHD c/o Susan D. Goldstein-Falk Official Correspondent for Guthrie Medicare Products (NS) SDN BHD MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re : K993793 Pre-powdered latex patient examination glove Trade Name: Regulatory Class: I Product Code: LYY Dated: November 5, 1999 Received: November 9, 1999

Dear Ms. Goldstein-Falk:

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 The general controls provisions of the Act 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. ਨੂੰ 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 requlation 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 not affect any

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Page 2 - Ms. Goldstein-Falk

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 asbeins 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 requlation (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

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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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. 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

GUTHRIE MEDICARE PRODUCTS (NS) SDN BHD Applicant: __ 510(k) Number (if, known) Devici: Name of Pationt Latex Examination Glove Indications For Use:

> Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ______________________________________________________________________________________________________________________________________________________________________________ Per 21 CFR 801.109 (Optional Formal 1-2-96) **

Over-The-Counter

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

Qhin S. Lim

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

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