DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES

K971424 · Ansell Perry · LYY · Jun 4, 1997 · General Hospital

Device Facts

• Record ID: K971424
• Device Name: DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
• Applicant: Ansell Perry
• Product Code: LYY · General Hospital
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.

Device Story

Dermaclean X-AM™ is a powder-free latex patient examination glove. Device serves as a protective barrier worn on the examiner's hand during medical examinations to prevent contamination between the patient and the examiner. It is intended for use in clinical settings by healthcare professionals. The device is a disposable, single-use product.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Latex. Form factor: Powder-free examination glove. Single-use, disposable.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner.

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

JUN - 4 1997

Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Incorporated _ 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-9987

K971424 Re : Dermaclean X-AM™ Powder-Free Latex, Trade Name: Examination Gloves with Protein Labeling Claim Requlatory Class: T Product Code: LYY Dated: April 16, 1997 Received: April 18, 1997

Dear Mr. Chatterton:

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. ಕಿ 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Chatterton

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 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 (800) 63 -2041 or at [phone].

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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## INDICATIONS FOR USE

| Applicant: | Ansell Perry Inc. |
|---------------------------|-----------------------------------------------------------------|
| 510(K) Number (if known): | K971424 * |
| Device Name: | Patient Examination Glove, Powder Free with Protein Label Claim |

Indications For Use:

A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

| | <i>S. Lin</i> |
|---------------------------------------------------------------------|---------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971424 |

| Prescription Use 1 CFR 801.109 | |
|--------------------------------|--|
|--------------------------------|--|

OR

| Over-The-Counter | X |
|------------------|---|
|------------------|---|

(Optional Format 1-2-96)

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