NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE

K042378 · Shijiazhuang Tillotson Rubber Products Co., Ltd. · LZA · Sep 20, 2004 · General Hospital

Device Facts

• Record ID: K042378
• Device Name: NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
• Applicant: Shijiazhuang Tillotson Rubber Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 20, 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 blue nitrile patient examination glove; worn by healthcare examiners on hands or fingers. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical or medical settings. Provides protection during examinations; no specific diagnostic or therapeutic output. Benefits patient and examiner by reducing risk of infection transmission.

Clinical Evidence

No clinical data. Bench testing only: physical and dimensions testing (ASTM D6319-00aE3), 1000 ml water fill test for pinholes, and biocompatibility testing (primary skin irritation and sensitization). Residual powder testing per ASTM D6124-01 confirmed powder-free status.

Technological Characteristics

Material: Nitrile rubber. Standards: ASTM D6319-00aE3, ASTM D6124-01. Form factor: Disposable patient examination glove. Powder-free (≤ 2 mg powder per glove). Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

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

• True Advantage Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove (K013016)

Submission Summary (Full Text)

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## SEP 2 0 2004

# 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: _ k_042378

## 1. Submitter's Identification:

Mr. Yang Ying Shijiazhuang Tillotson Rubber Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China

Date Summary Prepared: August 30, 2004

## 2. Name of the Device:

Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove

### 3. Predicate Device Information:

Tillotson Healthcare Corp.

True Advantage Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove (K013016)

### 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:

Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder Free Blue Nitrile Patient Examination Glove is substantially equivalent in safety and effectiveness to the Tillotson Healthcare Corp. True Advantage Non-Sterile Powder Free Blue Nitrile Patient Examination Glove.

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

The standards used for Shijiazhuang Tillotson Rubber Products Co., Ltd. glove production are based on ASTM-D-6319-00aE3. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 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:

Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder Free Blue Nitrile Patient Examination Glove 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Tillotson Rubber Products Compamy Limited Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821

Re: K042378

R042378
Trade/Device Name: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 1, 2004 Received: September 1, 2004

Dear Mr. Chu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rottewou your was 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to ac nove that metic Act (Act) that do not require approval of a premarket the rederal 1 004, Drag, and Sommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providions of the sistration, 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 If your device is classified (500 as 1011). Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the becas nouncements 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 Please oc auvisor that I DT 3 issuainse on that your device complies with other requirements Incall that I DX mas made a actes and regulations administered by other Federal agencies. of the Act of any I oderal blance tax sequirements, including, but not limited to: registration 1 ou must conting (21 CFR Part 801); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 et revers), systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in at a 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) Fins feter will and in Jose Finding of substantial equivalence of your device to a premitset notification. - The Pire 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 desite specific at 12 mpliance 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 vours,

Clus

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

k 042378 510(k) NUMBER (IF KNOWN) : Shijiazhuang Tillotson Rubber Products Co., Ltd. APPLICANT: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove DEVICE NAME:

INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical purposes 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 X (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)

Kein Muly

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042378