AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE

K993080 · Medtexx Partners, Inc. · LYY · Oct 20, 1999 · General Hospital

Device Facts

• Record ID: K993080
• Device Name: AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
• Applicant: Medtexx Partners, Inc.
• Product Code: LYY · General Hospital
• Decision Date: Oct 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

AMBIDERM Powder Free Latex Examination Glove (coloured) 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 protective barriers worn on the hands of healthcare personnel. The gloves are manufactured from natural rubber compound and are available in violet, blue, green, or pink colors. They are used in clinical settings to prevent contamination between the wearer and the patient. The device functions as a physical barrier; it does not involve electronic inputs, algorithms, or software. The healthcare provider dons the gloves manually before patient interaction to reduce the risk of infection transmission.

Clinical Evidence

No clinical tests were conducted. Nonclinical evidence includes bench testing per ASTM D 3578-99 and 21 CFR 800.20, and animal studies (rabbit skin irritation, guinea pig sensitization) confirming biocompatibility. Starch presence was tested via USP iodine test with negative results.

Technological Characteristics

Material: Natural rubber compound. Form factor: Powder-free examination glove. Colors: Violet, Blue, Green, Pink. Standards: ASTM D 3578-99. Biocompatibility: Tested for skin irritation and sensitization. Protein content: 50 micrograms or less of total water extractable protein per gram.

Indications for Use

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

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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OCT 20 1999

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## 510(k) SUMMARY

Attachment 15

K993080

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## AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES

ないということです

| Submitter's Name : | MEDTEXX PARTNERS INC. |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address : | |
| Submitter's Phone Number | |
| Submitter 's Fax Number : | |
| Name of Contact Person : | |
| Date of Preparation : | July 9, 1999 |
| Name of Device : | |
| Trade Name : | AMBIDERM POWDER FREE LATEX<br>EXAMINATION GLOVES |
| Common Name | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which<br>Equivalency is Being Claimed : | Ambiderm Powder Free Latex Examination<br>Gloves as described in the 510(k) notification are<br>substantially equivalent to the Class 1 patient<br>examination glove 80LYY. It meets all the<br>current spec listed under the ASTM Specification<br>D 3578 - 99 Standard Specification for Rubber<br>Examination Gloves. |

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| Description of the Device : | Ambiderm Powder Free Latex Examination<br>Gloves meet the current specifications listed<br>under the ASTM Specification D 3578 - 99<br>Standard Specification for Rubber Examination<br>Gloves. They are either Violet, Blue, Green or<br>Pink colour. |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device: | Ambiderm Powder Free Latex Examination<br>Gloves are intended for single use for medical<br>purposes and are worn on the hand of health care<br>and similar personnel to prevent contamination<br>between the health care personnel and the<br>patients. |
| Summary of Technological<br>Characteristics Compared to the Predicate<br>Device : | There are no different technological<br>characteristics. Gloves are made from natural<br>rubber compound and the initial products are<br>powder free latex examination gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-99<br>and 21 CFR 800.20. Gloves meet all the current<br>specifications listed under the ASTM<br>Specification D 3578 - 99 Standard Specification<br>for Latex Examination Gloves.<br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the guinea<br>pig indicate no irritation or sensitization.<br>Final product is negative for the test for presence<br>of starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this<br>510(k). |
| Conclusions Drawn for the Nonclinical<br>and Clinical Tests : | Nonclinical laboratory and animal data indicate<br>that the pre - powdered natural product meets all<br>performance and biocompatability requirements. |

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| Other Information Deemed Necessary by FDA : | Not applicable |
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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1999

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

K993080 Re: AMBIDERM Latex Examination Gloves (Violet, Trade Name: Blue, Green, and Pink), containing 50 microgram or less of total water extractable protein per gram Class: I Product Code: LYY Dated: September 14, 1999 Received: September 14, 1999

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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

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Page 2 - Mr. Smith

the Federal Register. Please note: this response to your the reactal notification submission does not affect any obligation you might have under sections 531 through 542 of obilgation 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 premation 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

hy A. Ulatowski Timot 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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K993080

Page 1 of 1

510(k) Number (if known):

Device Name: AMBIDERM Powder Free Latex Examination Gloves (Contoured) Pink, Orolet , િરિય contains: 50 mig Water Extract able Profeit m Ci

Classification Panel: 80LYY

Indications for Use:

AMBIDERM Powder Free Latex Examination Glove (coloured) 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

Over-the-Counter Use or

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospițal D E 10(k) Number .

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