POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)

K022530 · Hycare Intl. Co., Ltd. · LYY · Aug 26, 2002 · General Hospital

Device Facts

• Record ID: K022530
• Device Name: POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
• Applicant: Hycare Intl. Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Aug 26, 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 powdered latex examination glove; worn on examiner's hand or finger; serves as protective barrier; prevents cross-contamination between patient and healthcare professional; used in clinical settings including hospitals, clinics, and dental offices; manufactured with protein labeling (200 ug/g or less).

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 5712-99, ASTM D 3578-01, ASTM D 6124-99, ASTM D 5151-99, and ISO 2859 standards. Biocompatibility testing included dermal sensitization and primary skin irritation.

Technological Characteristics

Powdered latex examination glove. Protein content labeled at 200 ug/g or less. Standards: ASTM D 5712-99 (protein), ASTM D 3578-01 (physical properties), ASTM D 6124-99 (residual powder), ASTM D 5151-99 (leak test), ISO 2859 (sampling).

Indications for Use

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

• Premier Pathway (K001327)
• SGMP Company Ltd. (K000390)

Submission Summary (Full Text)

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AUG 2 6 2002

K022530

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: | 29 July 2002 |
| Device Name: | POWDERED LATEX EXAM GLOVES,<br>WITH PROTEIN LABELING (200 ug/g or less)<br>Class I Device, 80LYY |
| Proprietary Name: | (Multiple Labels) Powdered Latex Exam Gloves,<br>With Protein Labeling (200 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 Premier<br>Pathway K001327, and SGMP Company Ltd. K000390. |

EXHIBIT K
Page 39 of 40

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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 5712-99 ASTM D 3578-01 ASTM D 6124-99 ASTM D 5151-99 ISO 2859

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

This device is substantially equivalent to the devices approved as K001327 and K000390.

EXHIBIT K
Page 40 of 40

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 26 2002

Hycare International Company, Limited C/O Ms. Janna P. Tucker Official Correspondent for Hycare International Company, Limited Tucker and Associates 198 Avenue De La D' emerald Sparks. Nevada 89434-9550

Re: K022530

> Trade/Device Name: Powdered Latex Exam Gloves with Protein Labeling 200 Microgram or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 29, 2002 Received: July 31, 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.

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## Page 2 - Ms. Tucker

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,

Timothy A. Ulatowski

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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## INDICATIONS FOR USE

| APPLICANT: | HYCARE INTERNATIONAL, CO., LTD |
|----------------|---------------------------------------------------------------------------------------------------------------------|
| 510(k) NUMBER: | K022530 |
| DEVICE NAME: | POWDERED LATEX EXAM GLOVES,<br>WITH PROTEIN LABELING (200 ug/g or less) of Total Water Extractable Protein per gram |

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)

EXHIBIT B
Page 2 of 40

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Olin S. Lim

(Division Sign-Off) on Sion Sign-Olf)
Division of Anesthesiology, General He Infection of Anesthesiology
Infection Control, Dental L

510(k) Number: 2