SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES

K994248 · Shinemound Enterprise, Inc. · LYZ · Jan 28, 2000 · General Hospital

Device Facts

• Record ID: K994248
• Device Name: SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
• Applicant: Shinemound Enterprise, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination gloves 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

Disposable synthetic vinyl patient examination gloves; beige pigment added. Worn by healthcare examiners on hands or fingers. Primary function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical or medical settings. Single-use, non-sterile device.

Clinical Evidence

No clinical data provided; device is a standard patient examination glove.

Technological Characteristics

Synthetic vinyl material; beige pigment additive; disposable; non-sterile; form factor: hand-shaped glove.

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. Suitable for general patient examination 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 2 8 2000

Mr. Huan-Chunq Li Vice President Shinemound Enterprise, Incorporated 17A Sterling Road North Billerica, Massachusetts 01862

Re: K994248 Disposable Pre-powdered Synthetic Vinyl Trade Name: Patient Examination Gloves With Beige Pigment Additives (Brand Name: Sensi-Pro) Requlatory Class: I Product Code: LYZ Dated: December 14, 1999 Received: December 16, 1999

Dear Mr. Li:

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 Regulations, Title 21, Parts 800 to 895. ಡಿ 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) rill 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 not affect any

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Paqe 2 - Mr. Li

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 findinq 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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 G

## INDICATION FOR USE

Huan-Chung Li, Shinemound Enterprise, Inc. -----------------------------------------Applicant: * Kgq4248 510K Number(if known): Device Name: Prepowdered Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro) Indication For Use:

A patient examination gloves 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.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96) OR

Over-The-Counter Use X

* For a new submission, do NOT fill in the 510(K) number blank

Qhin S. Lim

(Division Sign-Off) Division of Dental, Infection and General Hospița 510(k) Number