AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)

K994131 · Medtaxx Partners · LYY · Feb 7, 2000 · General Hospital

Device Facts

• Record ID: K994131
• Device Name: AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)
• Applicant: Medtaxx Partners
• Product Code: LYY · General Hospital
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Device Story

Ambiderm Powder Free Latex Examination Gloves are single-use, black-colored, polymer-coated natural rubber latex gloves. Worn by healthcare and similar personnel, they serve as a protective barrier to prevent cross-contamination between the wearer and the patient. The device is used in clinical or medical settings. It provides protection through its physical material properties, meeting ASTM D 3578-99 standards for latex examination gloves. The device is non-sterile and intended for manual application.

Clinical Evidence

No clinical tests were conducted. Non-clinical evidence includes biocompatibility testing (primary skin irritation in rabbits and delayed contact sensitization in guinea pigs) and physical performance testing per ASTM D 3578-99 and 21 CFR 800.20. The product is negative for starch presence via USP iodine test.

Technological Characteristics

Material: Natural rubber latex compound. Form factor: Ambidextrous, black-colored, polymer-coated examination glove. Standards: ASTM D 3578-99. Protein content: Claimed 50 micrograms or less per gram. Sterilization: Not specified (non-sterile). Connectivity: None.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use protective barrier to prevent cross-contamination between the wearer and the patient.

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.

Predicate Devices

• Ambiderm Powder Free Latex Examination Gloves (80LYY)

Submission Summary (Full Text)

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# 510(K) SUMMARY

## AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS

### Submitter's Name:

### MEDTEXX PARTNERS INC.

### Submitter's Address:

Name of Contact Person:

Date of Preparation:

Name of Device:

Trade Name:

Common Name: Classification Name:

Legally Marketed Device to Which Equivalency is Being Claimed:

December 6, 1999

AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAM

Latex Examination Gloves Patient Examination Gloves

Ambiderm Powder Free Latex Examination Gloves as described in the 510(k) notification are substantially equivalent to the class I patient examination glove 80LYY. It meets all the current spec listed under the ASTM specification D 3578-99 standard specification for rubber examination gloves.

Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are black in color.

Description of the Device:

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## Intended Use of the Device:

Summary of Technological Characteristics Compared to the Predicate Device:

Brief Discussion of Nonclinical Tests:

Brief Discussion of Clinical Tests:

Conclusions Drawn for the Nonclinical and Clinical Tests:

Other information Deemed Necessary by FDA:

Ambiderm Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

There are no different technological characteristics. Gloves are made from natural rubber compound and the initial products are powder free latex examination gloves.

Testing is performed as per ASTM D 3578-99 and 21 CFR 800.20. Gloves meet all the current specifications listed under the ASTM specifications D 3578-99 standard specification for latex examination gloves.

Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization.

Final product is negative for the test for presence of starch using the USP iodine test.

No new clinical test were conducted under this 510(K)

Nonclinical laboratory and animal data indicate that the prepowdered natural product meets all performance and biocompatibility requirements.

Not Applicable

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Medtexx Partners, Incorporated c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114

K994131 Re : AMBIDERM Powder Free Latex Examination Trade Name: Gloves (Black Colored), with Protein Claims of 50 Micrograms or Less Per Gram Requlatory Class: I Product Code: LYY November 30, 1999 Dated: December 7, 1999 Received:

Dear Mr. Smith:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. प्र 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 - Mr. Smith

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 debting 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 ene regulacion chorolor (112FR 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

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):

Device Name: AMBIDERM Powder Free Latex Examination Gloves (Black Colored), with Protein Claims of 50 Micrograms or Less Per Gram.

Classification Panel: 80LYY

Indications for Use:

AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use

Clim Silim

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