POWDER-FREE EXAM GLOVES

K970773 · Pt. Sarana Indoprotex · LYY · Dec 4, 1997 · General Hospital

Device Facts

• Record ID: K970773
• Device Name: POWDER-FREE EXAM GLOVES
• Applicant: Pt. Sarana Indoprotex
• Product Code: LYY · General Hospital
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Patient examination gloves are “disposable medical devices intended for medical purposes that are worn on the examiner’s hand to help prevent contamination between patient and examiner”.

Device Story

Disposable latex patient examination gloves; powder-free; worn on examiner's hands; intended to provide barrier protection against contamination between patient and examiner; used in clinical or medical settings; non-sterile; single-use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Latex material; powder-free; disposable; non-sterile; form-fitting glove design.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand to prevent cross-contamination between patient and examiner in medical settings.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC - 4 1997

MD Yusof Bin Ibrahim
PT. Sarana Indoprotex
JL. IR. Sutami KM. 07
P.O. Box 214 TNK, Bandar
Lampung 35001
Indonesia

Re: K970773
Trade Name: Powder-Free, Latex Patient Examination Gloves
Regulatory Class: I
Product Code: LYY
Dated: November 21, 1997
Received: November 21, 1997

Dear Mr. Ibrahim:

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 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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Page 2 - Mr. Ibrahim

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
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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510(k) Number (if known): K970773

Device Name: Latex Patient examination gloves, Powder Free

Indications For Use: Patient examination gloves are “disposable medical devices intended for medical purposes that are worn on the examiner’s hand to help prevent contamination between patient and examiner”.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K970773

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)