DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR

K111240 · Xuzhou Full Sun Medical Products , Ltd. · LYZ · Jul 14, 2011 · General Hospital

Device Facts

• Record ID: K111240
• Device Name: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
• Applicant: Xuzhou Full Sun Medical Products , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 14, 2011
• Decision: SESE
• Submission Type: Abbreviated
• 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, non-sterile, powder-free vinyl synthetic examination glove; blue color. Worn on examiner's hand or fingers during medical examinations. Acts as a physical barrier to prevent contamination between patient and examiner. Single-use device. Available in sizes XS, S, M, L, XL.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D5250-06 (dimensions, physical properties), ASTM D5151-06 (pinholes), 21 CFR 800.20 (pinholes), and ASTM D6124-06 (powder residue). Biocompatibility confirmed via ISO 10993-10 testing for primary skin irritation and dermal sensitization.

Technological Characteristics

Material: Polyvinyl Chloride (PVC). Form factor: Disposable glove with separate finger/thumb sheaths. Sizes: XS-XL. Standards: ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or fingers 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

• PT Synthetic Medical Vinyl Patient Examination Gloves, Powder Free (K963751)

Submission Summary (Full Text)

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# XUZHOU FULL SUN MEDICAL PRODUCTS LT

Bihe Industry Area, Yitang Town, Pizhou County

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Tel: [phone] Fax: [phone]

#### 510K Summary:

Date of Summary: June 23, 2011

This summary of 510k safety and effectiveness information is being submitted in accordance with requirements of 21CFR 807.92

#### Submitter & Foreign Manufacture Identification

Xuzhou Full Sun Medical products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu 221316 China TEL: [phone] FAX: [phone] Ms. Hsun-Hui Huang E-mail:[e-mail]

US Agent and Contact Person Elizabeth Deng 5748 Eaglewood Place, Rancho Cucamonga, Ca 91739 TEL: [phone] E-Mail: [e-mail]

Device Name: Disposable Powder Free Vinyl Synthetic Examination Glove, Blue Color Proprietary name: Powder Free Vinyl Patient Examination Gloves (or other clients private labeling) Common Name: Patient examination glove Classification Name: Patient examination glove Device Classification: I Regulation Number: 21CFR880.6250 Product Code: LYZ

#### Predicate Device Information:

K963751 "PT Synthetic Medical Vinyl Patient Examination Gloves, Powder Free" manufactured by "Shanghai PT Plastics Enterprise Company Ltd.

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## Device description:

ﺗﺮ

Powder free vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06----------------------------------------------------------------------------------------------------------------------------------------------------------

#### 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.

#### Comparison to Predicate Devices:

Powder free vinyl patient examination gloves, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications and performance.

K963751 "PT Synthetic Medical Vinyl Patient Examination Gloves, Powder Free" manufactured by "Shanghai PT Plastics Enterprise Company Ltd.

# The following table shows similarities and differences of use, design, and material between our device and the predicate devices:

| Description | Our Device | Predicate Device (K96371) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indication for use | Disposable device intended for medical purposes<br>that is worn on the examiner's hand or finger to<br>prevent contamination between patient and<br>examiner | Same |
| Basic Design | Gloves have separate sheaths or openings for each<br>finger and the thumb | Same |
| Materials | Poly Vinyl Chloride | Same |
| Size | XS,S,M,L,XL | Same |
| Single Use | Yes | Yes |
| Sterile | Non sterile | Non sterile |

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. The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus, and results for Powder Free Vinyl Patient Examination Gloves (or other clients private labeling); manufactured by XUZHOU-FULL SUN-MEDICAL-PRODUCTS-LTD.metall relevant requirements in the test standards, and are comparable to the predicate device.

| Description | Our Device | Predicate Device (K96371) |
|----------------------------------------------|--------------------------------------------|---------------------------|
| Dimension | Meets ASTM D5250-06 | Meets |
| Physical Property | Meets ASTM D5250-06 | Meets |
| Free of Pinhole | Meets ASTM D5151-06<br>Meets 21 CFR 800.20 | Meets |
| Residue Powder | Meets ASTM D6124-06 | Meets |
| Primary Skin<br>Irritation<br>(ISO 10993-10) | Passes | Passes |
| Dermal<br>Sensitization<br>(ISO 10993-10) | Passes | Passes |

#### Substantial Equivalent Conclusions

Based on the comparison of intended use, design, materials, and performance, our vinyl disposable examination gloves powder free are substantial equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures connected at the shoulders.

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

Xuzhou Full Sun Medical Products Limited C/O Ms. Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California 91739

JUL 1 4 2011

Re: K111240

Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Glove Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 23, 2011 Received: June 28, 2011

· Dear Ms. Deng:

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. Deng

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Ab outFDA/CentersOffices/CDRH/C DRHOffices/ucm115809.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/R cportaProblem/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.

Anthony D. Watson
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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## Indications for Use

| Applicant: | XUZHOU FULL SUN MEDICAL PRODUCTS LTD. | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| 510(k) Number (if known): | K111240 | |
| Device Name: | Disposable Powder Free Vinyl Synthetic Examination Glove | |
| | Blue Color | |
| Indications for Use: | A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER. | |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use X<br>(21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the comments of the contribution of the comments of the subscribed

Cakil Ganguly
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111240

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