MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL

K023153 · Ansell Healthcare Products, Inc. · LYY · Nov 13, 2002 · General Hospital

Device Facts

• Record ID: K023153
• Device Name: MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL
• Applicant: Ansell Healthcare Products, Inc.
• Product Code: LYY · General Hospital
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Device Story

Non-sterile, disposable, powder-free medical examination gloves; coated with aloe and glycerol; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner; used in clinical settings; no electronic or mechanical components.

Clinical Evidence

Bench testing only. Device meets ASTM D 3578-01a requirements for physical properties, dimensions, and freedom from holes (ASTM D 5151-99). Biocompatibility testing (primary skin irritation and guinea pig sensitization) passed.

Technological Characteristics

Latex examination glove; powder-free (residue < 2 mg/glove); contains aloe and glycerol; meets ASTM D 3578-01a and ASTM D 5151-99 standards; non-sterile.

Indications for Use

Indicated for use as a patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner in a medical setting.

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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K023153

Image /page/0/Picture/1 description: The image shows the logo for Ansell Professional Healthcare. The word "Ansell" is in large, bold, black letters, with a curved line underneath. Below that, the words "PROFESSIONAL HEALTHCARE" are in smaller, black letters.

## NOV 1 3 2002

1875 Harsh Ave. S.E. • P.O. Box 550 Massillon, OH 44648-0550 U.S.A. 330.833.2811 / 800.321.9752 U.S.A. 330.833.5991 Fax ansellhealthcare.com

Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax: [phone]

- [1] Summary
- Ansell Healthcare Products Inc. [2] 1875 Harsh Avenue SE Massillon, Ohio 44646

James R. Chatterton Contact: Telephone: [phone] Fax: [phone]

September 18, 2002

- Trade Name: Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and [3] Glycerol Common Name: Examination Gloves Classification Name: Glove, Patient Examination, Latex
- Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol [4] meet all of the requirements of ASTM D 3578-01a22.
- [રી Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol meet all the current specifications for ASTM D 3578-01a €2 Rubber Examination Gloves.
- [[]] Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|---------------------|-----------------------------------------------------------------------------|
| Dimensions | Meets ASTM D 3578-01a€2 |
| Physical Properties | Meets ASTM D 3578-01a€2 |
| Freedom from holes | Meets ASTM D 3578-01a€2<br>Meets ASTM D 5151-99 |
| Powder-Free | Meets ASTM D 3578-01a€2<br>Not more than 2 mg residue by mass per<br>glove. |

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K023153

Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax:

Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization

Passes Passes

- (8) The performance test data of the non clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. ləl
- [10] It is concluded that the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Modified) are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:

ASTM listed standards, FDA hole requirements, and labeling claims for the product.

- [11] This summary will include any other information reasonably deemed necessary by the FDA.

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Image /page/2/Picture/0 description: The image shows a partial view of a document or logo. On the left, there's a stylized graphic that appears to be a series of curved lines or shapes, possibly representing waves or a stylized symbol. To the right of this graphic, the word "DEPART" is visible, suggesting that the document or logo is related to a department or organization with a name starting with these letters. The overall image is cropped, so the full context and meaning are not immediately clear.

NOV 13 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James R. Chatterton Vice President Regulatory Ansell Healthcare Products, Incorporated 1875 Harsh Avenue, S.E. · Massillon, Ohio 44646-7199

Re: K023153

Trade/Device Name: Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYY Dated: October 25, 2002 Received: October 28, 2002

Dear Mr. Chatterton:

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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Page 2 -- Mr. Chatterton

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.

for Susan Penner
Timothy A. Ullatowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Number (if known)

KC 23153

Device Name

Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Green)

Indications for Use

Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes 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)

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter Use

Clins. Ps

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K023153