LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING

K973664 · Evergrade Healthcare Products Sdn Bhd · LYY · Mar 13, 1998 · General Hospital

Device Facts

• Record ID: K973664
• Device Name: LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
• Applicant: Evergrade Healthcare Products Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Mar 13, 1998
• 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 latex examination glove; powder-free; features protein and hypoallergenic labeling. Used by healthcare professionals (dentists, doctors, laboratory staff) in clinical and hospital settings. Acts as a physical barrier on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Benefits include reduced risk of contamination and potential reduction in allergic response due to protein labeling.

Clinical Evidence

Bench testing only. Device met ASTM D 3578-95 (Rubber Exam Gloves) and ASTM D 5712 (RRIM Modified Lowry Microassay for protein content: 11 +/- 4 mg/g internal, 12 +/- 4 mg/g external). Passed FDA water leak test (AQL 4.0). Biocompatibility demonstrated via primary skin irritation and a 200-subject repeated insult patch test for dermal sensitization.

Technological Characteristics

Latex material; powder-free. Complies with ASTM D 3578-95 (Standard Specification for Rubber Exam Gloves) and ASTM D 5712 (Protein Content). Biocompatibility verified via dermal sensitization and irritation testing. No electronic or software components.

Indications for Use

Indicated for use by healthcare professionals in dentists' and doctors' offices, laboratories, clinics, and hospitals as a disposable protective barrier worn on the examiner's hand or finger 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

• Latex Exam Gloves, powder-free, with Protein Labeling and Hypoallergenic Claims (K955918)

Submission Summary (Full Text)

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MAR 1 3 1998

## JANNA TUCKER & ASSOCIATES

973664 510(K) SUMMARY

19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: [phone] Fax: [phone]

Janna Tucker & Associates Submitted By: 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: [phone]

Contact Person:

Date of Submission: August 19, 1997

Latex Exam Glove, Powder Free with Device Name: Protein and Hypoallergenic Labeling

Classification Name: Latex Exam Glove, 80LYY

(Various Labels) Latex Exam Glove, Powder Free, with Protein and Proprietary Name: Hypoallergenic Labeling

Janna P. Tucker, Official Correspondent of Evergrade

This device will be marketed to healthcare professionals at dentists Labels/Labeling: and doctor's offices, laboratories, clinics and hospitals through its intended use.

Healthcare Products SDN. BHD.

A patient examination glove is a disposable device intended for Intended Use: medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Substantial Equivalence:

The above device is equivalent to those in commercial distribution. These latex gloves are to be worn as a protective device on the examiners hand or finger.

Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is Substantially Equivalent to the device manufactured by Sinochem Ningbo, K955918, Latex Exam Gloves, powder-free, with Protein Labeling and Hypoallergenic Claims.

EXHIBIT H
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Test Results (Means

and/or Results):

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

ASTM D 3578-95, Standard Specification for Rubber Exam Gloves ASTM D 5712, RRIM Modified Lowry Microassay: Protein Content, mg/g (against BSA): Internal Surface: 11 +/- 4; External Surface: 12 +/- 4 FDA Water Leak Test AQL 4.0 Primary Skin Irritation Test Dermal Sensitization Study Biocompatibility [Repeated Insult Patch (200 Subjects)]

Conclusions:

This device is substantially equivalent to the Sinochem Ningbo device approved under 510(k) K955918.

EXHIBIT M
Page 46 of 46

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

Evergrade Healthcare Products Sdn Bhd C/O Janna Tucker & Associates 19001 S. Richfield #185 85614 Green Valley, Arizona

Re : K973664 Latex Examination Glove, Powder-Free, Trade Name: ade Name: (50 Micro grams or less) Requlatory Class: I Product Code: LYY February 4, 1998 Dated: February 10, 1998 Received:

Dear Ms. Tucker:

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 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 Requiations, Title 21, Parts-800-to-895. A- ---------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Ms. Tucker

concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any 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 requlations.

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 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

Timoth Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## INDICATIONS FOR USE

| Applicant: | EVERGRADE HEALTHCARE PRODUCTS, SDN. BHD. |
|---------------------------|---------------------------------------------|
| 510(k) Number (if known): | K973664 |
| Device Name: | Latex Exam Glove, Powder Free, with Protein |

Indications For Use:

n and Hypoallergenic Labeling

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)

Qiin S. him

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter X

(Optional Format 1-2-96)

EXHIBIT B

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