SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL

K103770 · Syntex Healthcare Products Co., Ltd. · LZA · Apr 21, 2011 · General Hospital

Device Facts

• Record ID: K103770
• Device Name: SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
• Applicant: Syntex Healthcare Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable, non-sterile nitrile examination glove; worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings; operated by healthcare professionals. Benefits patient and examiner by reducing risk of contamination.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against ASTM D6319-00a (2005)e1 for dimensions, physical properties, and freedom from holes. Biocompatibility confirmed via ISO 10993 Part 10, 16CFR 1500.41, and 16CFR 1500.3.

Technological Characteristics

Nitrile rubber examination glove; powder-free. Meets ASTM D6319-00a (2005)e1 and ASTM D6124-06 standards. Biocompatible per ISO 10993 Part 10. Non-sterile.

Indications for Use

Indicated for use as a disposable, non-sterile patient examination glove worn on the examiner's hand or finger to prevent 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

• Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue (K070861)

Submission Summary (Full Text)

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EXHIBIT #1 Page 1 of 3

# APR 2 1 2011

## 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: K103770

#### 1. Owner's Identification:

Mr. Shen Xiaolin Syntex Healthcare Products Co., Ltd. No 1 Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, China 052360 Tel: [phone]

Submitter: Kathy Liu Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone] Date Summary Prepared: February 19, 2011

#### 2. Name of the Device:

Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink Common Name: Exam Gloves

## 3. Predicate Device Information:

Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue (K070861)

## 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

## 5. Intended Use of the Device:

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

#### 6. Comparison to Predicate Devices:

Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Examination Glove, Pink is substantially equivalent in safety and effectiveness to the Hong Xin Rubber Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue.

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# K103770

## EXHIBIT #1 Page 2 of 3

| Technological Characteristics | Comparison Result |
|---------------------------------------------------------|----------------------------|
| Intended use | Identical |
| Indications for use | Identical |
| Target population | Identical |
| Anatomical sites | Identical |
| Where used (hospital, home,<br>ambulance, etc) | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Human factors | Identical |
| Design | Similar |
| Performance | Identical |
| Standards met | Identical |
| Materials | Similar |
| Biocompatibility | Identical |
| Compatibility with the environment<br>and other devices | Identical |
| Sterility | Identical (Not applicable) |
| Electrical safety | Identical (Not applicable) |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Thermal safety | Identical (Not applicable) |
| Radiation safety | Identical (Not applicable) |

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

| Characteristics | Applicable FDA- Recognized<br>Standards | Performance Results |
|---------------------------------------------------|----------------------------------------------------|---------------------|
| Dimensions | ASTM D 6319-00a (2005)e1 | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Meets |
| Freedom from holes | ASTM D 6319-00a (2005)e1 | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1<br>ASTM D6124-06 | Meets |
| Primary Skin Irritation<br>and Skin Sensitization | ISO 10993 Part 10<br>16CFR 1500.41<br>16CFR 1500.3 | Meets |

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K103770

## EXHIBIT #1 Page 3 of 3

## 8. Labeling:

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

## 9. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

## 10. Conclusions:

Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Examination Glove, Pink conform fully to ASTM D6319-00a (2005)e1standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe and effective as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Syntex Healthcare Products Company, Limited C/O Ms. Kathy Liu Project Manager Surprotect, Incorporated 3973 Schaefer Avenue Chino, California 91710

APR 2 1 2011

Re: K103770

Trade/Device Name: Powder-Free Nitrile Examination Glove, Pink Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 3, 2011 Received: March 14, 2011

Dear Ms. Liu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Liu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm l 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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

## INDICATION FOR USE

510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:

103770 Syntex I-lealthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink

INDICATIONS FOR USE:

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

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AND/ OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter-Use _ イ (21CFR 801Subpart C)

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

| | Elizabeth H. F. Clamis William |
|---------------------|--------------------------------|
| (Division Sign-Off) | |

(Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103770