POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

K131344 · Shijiazhuang Wally Plastics Co., Ltd. · LYZ · Jan 30, 2014 · General Hospital

Device Facts

• Record ID: K131344
• Device Name: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shijiazhuang Wally Plastics Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.

Device Story

Disposable patient examination glove; constructed from PVC film; acts as a physical barrier to body fluids and bloodborne pathogens. Designed for use by healthcare examiners in clinical settings to prevent cross-contamination between patient and examiner. Tensile properties allow for hand conformation and flexibility during medical procedures. Device is non-sterile and intended for single-patient use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property testing (tensile strength, elongation), water leak testing for pinholes (ASTM D5151-06), residual powder testing (ASTM D6124-06), and biocompatibility studies (ISO 10993-10).

Technological Characteristics

Material: PVC with PU surface coating agent. Dimensions: Length ≥230mm. Physical properties: Tensile strength ≥14MPa, Elongation ≥300%. Standards: ASTM D5250-06 (Reapproved 2011), ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reapproved 2011), ISO 10993-10. Non-sterile, single-use.

Indications for Use

Indicated for use as a non-sterile, disposable medical 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

• POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD (K110945)

Submission Summary (Full Text)

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# Section C

# 510(k) Summary

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

"The assigned 510(k) number is: K131344 ." (applicant leave blank)

Premarket Notification [510(k)] Summary

((a)(1)). The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

Shijiazhuang Wally Plastic Co., Ltd. Submitter's name :

No. 78 Tongda Road, Jinzhou City. Hebei. 052260. China Submitter's address :

Zheng Jianming"

Phone number : (86) 31184322871

Fax number :

(86) 31184322871

Name of contact person:

18 Deceinber 2013 was Date. the summary prepared:

(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

| Device Name: | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves |
|-------------------------|---------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |

Product Code :

[(a)(3)]. An identification of the legally marketed device to which your firm is claiming. substantial equivalence .

Class I . Powder Free Yellow Synthelie Vinyl Patient Examination Gloves that meets all of the requirements of AST M'standard D 5250-06 (Reaffirmation 2011):

-Predicate device : POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD KIT0945

## Section C (rev.02)

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## [(a)(4)| A description of the device

· Device Description : Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

-- How the device functions:

PVC films form a barrier to body fluids and bloodborne Pathogens

-- Scientific concepts that form the basis for the device

The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

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- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM:D5250 and ASTM D5151 requirements. 1 1 1 1 1 1 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

# (a)(5)| The summary describes the intended use of the device

Device Intended Use: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.

((a)(6)) A summary of the technological characteristics of new device compared to the predicate device.

The Powder Free Yellow Synthetic Vinyl Patient Examination Gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Features &<br>Description | Predicate Device | Subject Device | Result of<br>Comparison | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | k110945- | K131344 | | |
| Company | ZHAOYANG PLASTIC CO., LTD | Shijiazhuang Wally Plastic<br>Co., Ltd. | | |
| Product name | POWDER-FREE YELLOW<br>SYNTHETIC VINYL PATIENT<br>EXAMINATION GLOVES | Powder Free Yellow<br>Synthetic Vinyl Patient<br>Examination Gloves | | |
| Product Code | LYZ | LYZ | Same | |
| Size | Small/ Medium/<br>Large/X large | Small/ Medium/<br>Large/X large | Small/<br>Medium/<br>Large/X large | |
| Intend for use | POWDER-FREE YELLOW<br>SYNTHETIC VINYL PATIENT<br>EXAMINATION GLOVES is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | Powder Free Yellow<br>Synthetic Vinyl Patient<br>Examination Gloves is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. | Substantially<br>equivalent | |
| Device<br>Description and<br>Specifications | Meets ASTM D5250-06<br>(Reapproved 2011) | Meets ASTM D5250 -06<br>(Reapproved 2011) | Substantially<br>equivalent | |
| Dimensions -<br>-- Length | Meets ASTM D5250-06<br>(Reapproved 2011)<br>≥230mm min. | 230mm min for all sizes | Substantially<br>equivalent | |
| Dimensions<br>- Width | Meets ASTM D5250-06<br>(Reapproved 2011)<br>Small 80-90 mm | Small 80-85 mm | Substantially<br>equivalent | |
| | | | | |
| | Dimensions<br>-- Thickness | Medium 90-100mm<br>Large 100-110mm<br>X large 110-120 mm<br>Meets ASTM D5250-06<br>(Reapproved 2011) | Medium 95-97 mm<br>Large 102-108mm<br>X large 114-118 mm | Substantially<br>equivalent |
| | Physical<br>Properties | Finger 0.05mm min.<br>Palm 0.08mm min.<br>Meets ASTM D5250-06<br>(Reapproved 2011)<br>Before aging/after aging<br>Elongation ≥300%<br>Tensile Strength≥14MPa | Finger 0.05mm min.<br>Palm 0.08mm min.<br>Before aging/after aging<br>Elongation ≥300%<br>Tensile Strength≥14MPa | Substantially<br>equivalent |
| | Freedom from<br>Pinholes | Meets<br>· 21 CFR 800.20<br>· ASTM D5250-06<br>(Reapproved 2011)<br>· ASTM D 5151-06<br>(Reapproved 2011) | Meets ASTM<br>D5151-06<br>(Reapproved 2011)<br>Holes<br>Inspection Level I<br>AQI 2.5 | Substantially<br>equivalent |
| | Residual Powder | Meets ASTM<br>D 6124-06<br>(Reapproved 2011) | D 6124-06<br>(Reapproved 2011)<br>Results generated values<br>below 2mg of residual<br>powder | Substantially<br>equivalent |
| | Compare all<br>materials used to<br>fabricate the<br>devices | PVC | PVC | Substantially<br>equivalent |
| | Dusting or<br>Donning<br>Powder: | PU | PU | Substantially<br>equivalent |
| | Dusting or<br>Donning<br>Powder: name | PU | Surface Coating Agent | Substantially<br>equivalent |
| | Compare<br>performance data<br>supporting<br>substantial<br>equivalence | Meets<br>· ASTM D5151-06<br>(Reapproved 2011)<br>· ASTM D5250-06<br>(Reapproved 2011)<br>· ASTM D6124-06<br>(Reapproved 2011) | Meets<br>· ASTM D5151-06<br>(Reapproved 2011)<br>· ASTM D5250-06<br>(Reapproved 2011)<br>· ASTM D6124-06<br>(Reapproved 2011) | Substantially<br>equivalent |
| | Single Patient<br>Use | Single Patient Use | Single Patient Use | Substantially<br>equivalent |
| | Biocompatibility | SKIN IRRITATION DERMAL and<br>SENSITIZATION STUDIES Meets<br>ISO 10993-10 | The test article was a<br>non-irritant or<br>non-sensitizer.<br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION STUDIES<br>Meets ISO 10993-10 | Substantially<br>equivalent. |
| | Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed: | -Powder-free<br>-Patient Examination Glove<br>-Yellow color<br>-non sterile<br>-Single Use Only<br>-Manufactured For:<br>-Lot | -Powder-free<br>-Patient Examination Glove<br>-Yellow color<br>-non sterile<br>-Single Use Only<br>-Manufactured For:<br>-Lot | Substantially<br>equivalent |

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:

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(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Realfirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006(E).

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

[(b)(3)] The conclusions drawn the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).

It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and the Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is as safe, as effective. and performs as well as the predicate device, POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHIAOYANG PLASTIC CO., LTD k110945

Section C (rev:02)

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

# January 30, 2014

Shijiazhuang Wally Plastics Company, Limited Mr. Chu Xiaoan Rm. 1606 Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA

Re: K131344

Trade/Device Name: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 18, 2013 Received: December 20, 2013

Dear Mr. Xiaoan:

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 - Mr. Xiaoan

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (2.1 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/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

Sincerely vours.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

*****

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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K 131344

#### Device Name

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

#### Indications for Use (Describe)

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a non-sterile intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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