SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES

K992156 · Ansell Perry · LYZ · Oct 27, 1999 · General Hospital

Device Facts

• Record ID: K992156
• Device Name: SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
• Applicant: Ansell Perry
• Product Code: LYZ · General Hospital
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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

Device Story

SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves are sterile, disposable gloves worn by healthcare examiners. The device acts as a physical barrier to prevent contamination between the patient and the examiner. The gloves are manufactured from polyvinyl chloride and are designed to meet established physical and biocompatibility standards. They are intended for use in clinical or medical settings where sterile examination conditions are required.

Clinical Evidence

No clinical data. Bench testing only, including physical properties, dimensions, freedom from holes (ASTM D 5151), and biocompatibility (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Material: Polyvinyl Chloride. Standards: ASTM D 5250 (dimensions, physical properties), ASTM D 5151 (freedom from holes), ASTM D 6124 (powder-free residue < 2 mg). Biocompatibility: Passes primary skin irritation and guinea pig sensitization tests. Form factor: Sterile, powder-free, disposable examination glove.

Indications for Use

Indicated for use by medical examiners as a sterile, disposable barrier 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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OCT 2 7 1999

SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax:

Checklist Section 21.0

| [1] | 510 (k) Summary |
|-----|-----------------|
|-----|-----------------|

- (2) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: [phone] Fax: [phone]

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

June 23, 1999

[3]

| Trade Name: | SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Sterile Examination Gloves |
| Classification Name: | Patient Examination Glove, Sterile |

- [4] SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves, meet all of the requirements of ASTM D 5250, Poly (Vinyl Chloride) Gloves for Medical Application.
- [ર] SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves meet all the current specifications for ASTM D 5250, Poly (Vinyl Chloride) Gloves for Medical Application.
- (୧) SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are sterile disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

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SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax: [phone]

| Characteristics | Standard |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Dimensions | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 |
| Freedom from holes | Meets ASTM D 5250<br>Meets ASTM D 5151 |
| Powder-Free<br>Meets described test in Attachment VI | Not more than 2 mg residue by mass.<br>Meets ASTM D 6124 and ASTM D 5250 |
| Biocompatability<br>Primary Skin Irritation in Rabbits<br>Guinea Pig Sensitization | Passes<br>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. [9]
- [10] It is concluded that SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:

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

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0CT 2 7 1999

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

Re : K992156

> Trade Name: SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 17, 1999 Received: September 20, 1999

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 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 (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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Chatterton

the Federal Register. Please note: this response to your che rederal neground submission does not affect any remarket notificacion babliable sections 531 through 542 of obligation you might have under becomic Product Radiation
the Act for devices under the Elections or regulations the Act for devices ander one Economics or regulations.

This letter will allow you to begin marketing your device as Inis recei will area your fromarket notification. The FDA described in your 510(x) prematice of your device to a legally
finding of substantial equivalence of your device for your finding of substancial equivalition in a classification for your marketed predicate device rebares in a sem-one of the market.

If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 cm Fare oss are oss artact the Office of
vitro diagnostic devices), please contact the for quocti vitro diagnostic devices), preabscetionally, for questions on Compliance at [phone]. "Addresses ontact
the promotion and advertising of your device, please contact the promotion and advercibing or jean-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entitled, "Misbranding »7 other general premarked notification - (2) circles under the Act may be information on your responsible mall Manufacturers Assistance obtained Trom the Division of Billing (801) or (301) 443-65597 or at at its toil-free number (000) obliga gov/cdrh/dsmamain.html".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

K99256 510(K) Number (if known): __

Vinyl Patient Examination Glove, Sterile, Powder Free Device Name:

Indications For Use:

A sterile 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)

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Prescription Use P -- 21 CFR 801.109

OR

(Division Sign-Off)

and General Hospital D 510(k) Numbar

Division of Dental, Infection Control

Over-The-Counter
(Optional Form)

-The-Counter

(Optional Format 1-2-96)

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