HYCARE LATEX EXAMINATION GLOVE, POWDER FREE

K020042 · Hycare Intl. Co., Ltd. · LYY · Jul 30, 2002 · General Hospital

Device Facts

• Record ID: K020042
• Device Name: HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
• Applicant: Hycare Intl. Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable powder-free latex examination glove; worn on hand or finger by healthcare professionals in clinical settings (hospitals, clinics, labs, dental offices). Acts as physical barrier to prevent cross-contamination between patient and examiner. Reduces protein content to 50 ug/g or less.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 5712-95 (protein content), ASTM D 3578-01 (physical requirements), ASTM D 6124-97 (residual powder), ASTM D 5151-00 (leakage), and ISO 2859 (sampling). Biocompatibility testing included cytotoxicity (Agar Diffusion), dermal sensitization, and primary skin irritation.

Technological Characteristics

Material: Latex. Powder-free. Protein content: ≤ 50 ug/g. Standards: ASTM D 5712-95, ASTM D 3578-01, ASTM D 6124-97, ASTM D 5151-00, ISO 2859. Biocompatibility: Cytotoxicity, dermal sensitization, and primary skin irritation testing performed.

Indications for Use

Indicated for use by healthcare professionals in dentist and doctor offices, laboratories, clinics, and hospitals as a 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.

Predicate Devices

• SGMP Co., Ltd. (K000391)
• Supergrade Healthcare, SDN BHD (K014134)

Submission Summary (Full Text)

{0}------------------------------------------------

(JUL 3 0 2002

K020042

510(k) SUMMARY

| Submitted For: | HYCARE INTERNATIONAL CO., LTD.<br>457/2 Moo 3, Airport Road, Hat-Yai<br>Songkhla, 90110, Thailand |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for Hycare International Co., Ltd.<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone:<br>775-342-2612<br>Fax:<br>775-342-2613<br>E-Mail:<br>[e-mail] |
| Date of Submission: | 08 July 2002 |
| Device Name: | POWDER-FREE LATEX EXAM GLOVES,<br>WITH PROTEIN LABELING (50 ug/g or less)<br>Class I Device, 80LYY |
| Proprietary Name: | (Multiple Labels) Powder-Free Latex Exam Gloves,<br>With Protein Labeling (50 ug/g or less) |
| Labels/Labeling: | This device will be marketed to healthcare professionals at<br>Dentist and Doctor Offices, Laboratories, Clinics and<br>Hospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand<br>or finger to prevent contamination between patient and<br>examiner. |
| Substantial Equivalence: | Both in its intended use and/or physical<br>characteristics, this device is equivalent to devices<br>currently marketed by U.S. companies. It is substantially<br>Equivalent to the devices manufactured by SGMP Co.,<br>Ltd. K000391, and Supergrade Healthcare, SDN BHD<br>K0114134. |

Atch 7 (Revised 7-12-02)
Page 7-1

{1}------------------------------------------------

510k) Summary page 2.

Test Results (Means and/or Successful Results:

This device has met or exceeded the following standards and/or tests:

ASTM D 5712-95 ASTM D 3578-01 ASTM D 6124-97 ASTM D 5151-00 ISO 2859

Cytotoxicity (Agar Diffusion)

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

This device is substantially equivalent to the devices approved as K000391 and K014134.

Atch 7
Page 7-2

{2}------------------------------------------------

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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a similar feature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 3 0 2002

Hycare International Company Limited C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D' Emerald Sparks. Nevada 89434-9550

Re: K020042

Trade/Device Name: Hycare Latex Examination Glove, Powder Free, with Protein Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 1, 2002 Received: July 5, 2002

Dear Ms. Tucker:

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.

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.

{3}------------------------------------------------

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.qoy/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE

| APPLICANT: | HYCARE INTERNATIONAL, CO., LTD |
|----------------|------------------------------------------------------------------------------|
| 510(k) NUMBER: | K020042 |
| DEVICE NAME: | POWDER-FREE LATEX EXAM<br>GLOVES, WITH PROTEIN LABELING<br>(50 ug/g or less) |

A 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.

(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__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Chiu S. Lin

(Division Sign-Off) Consion of Dental, Infection Control, Seneral Hospital Devices : " ivember ____________________________________________________________________________________________________________________________________________________________________

Atch 1
1 July 02