SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY

K042226 · Syntex Healthcare Products Co., Ltd. · LZA · Sep 30, 2004 · General Hospital

Device Facts

• Record ID: K042226
• Device Name: SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
• Applicant: Syntex Healthcare Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 30, 2004
• 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 nitrile examination glove; worn by clinicians to prevent cross-contamination between patient and examiner. Device provides barrier protection during medical examinations and handling of chemotherapy drugs. Manufactured from nitrile material; tested for physical dimensions, pinhole resistance, and biocompatibility. Used in clinical settings; operated by healthcare professionals. Output is a physical barrier; protects examiner from patient contaminants and patient from examiner contaminants.

Clinical Evidence

No clinical data. Bench testing only: physical and dimensions testing (ASTM D6319-00aE3, Inspection Level S-2, AQL 4.0), FDA 1000 ml water fill test (AQL 2.5, Inspection Level G-1), primary skin irritation, skin sensitization, and residual powder testing (ASTM D6124-01).

Technological Characteristics

Nitrile examination glove; powder-free (max 2 mg powder/glove). Complies with ASTM D6319-00aE3. Tested for chemotherapy drug use. Biocompatible (no primary skin irritation or sensitization).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Suitable for use with chemotherapy drugs.

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

• Syntex Powder-Free Nitrile Examination Glove (K020493)

Submission Summary (Full Text)

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## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _KO4 2226

## 1. Submitter's Identification:

Mr. Hao Jun Jie Syntex Healthcare Products Co., Ltd. No. 1 Fangjiazhuang Industrial Zone Xinji, Hebei Province P.R. China

Date Summary Prepared: July 01, 2004

## 2. Name of the Device:

Syntex Healthcare Products Co., Ltd.

Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy

## 3. Predicate Device Information:

Syntex Healthcare Products Co., Ltd.

Syntex Powder-Free Nitrile Examination Glove (K020493)

## 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.

#### 5. 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.

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#### 6. Comparison to Predicate Devices:

Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy is substantially equivalent in safety and effectiveness to the Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove.

## 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Syntex Healthcare Products Co., Ltd. glove production are based on ASTM-D-6319-00a€3. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove).

#### 8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

#### 9. Conclusions:

Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy conform fully to ASTM-D-6319-00a€3 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements. biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three parallel lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

SEP 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Syntex Healthcare Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821

Re: K042226

Trade/Device Name: Syntex Powder-Free Nitrile Examination Glove, Tested for Use With Chemotherapy Drugs-Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 13, 2004 Received: August 17, 2004

Dear Mr. Chu:

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 - Mr. Chu

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of advisod that 122 a determination that your device complies with other requirements Incall that I Dri has made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal based a requirements, including, but not limited to: registration 1 ou intiles compry wart 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 807), as ality 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) I mis letter will anow yourse of substantial equivalence of your device to a premarketed 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), If you desire specific af Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn 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 yours,

Chiao Liu, Ph.D.

Chiu Lin, Ph.D. 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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#### Attachment A

# INDICATIONS FOR USE

510(k) NUMBER' (IF KNOWN) : APPLICANT: DEVICE NAME:

K042226 Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove, Tested for USE WHO Chemotherapy DRUGS - BLUE

INDICATIONS FOR USE:

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrent of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K042226 |