POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

K110945 · Zhaoyang Plastic Co., Ltd. · LYZ · Sep 13, 2011 · General Hospital

Device Facts

• Record ID: K110945
• Device Name: POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
• Applicant: Zhaoyang Plastic Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 13, 2011
• 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 finger to prevent contamination between patient and examiner.

Device Story

Disposable synthetic vinyl patient examination glove; worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical/medical settings; non-sterile; yellow color; powder-free.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including dimension, physical properties, freedom from pinholes, powder residual, and biocompatibility (primary skin irritation and dermal sensitization) per ASTM D5250-06, ASTM D6124-01, and ISO 10993-10.

Technological Characteristics

Synthetic vinyl material; powder-free; non-sterile; dimensions and physical properties compliant with ASTM D5250-06; powder residual <2mg/glove per ASTM D6124-01; pinhole testing per 21 CFR 800.20; biocompatibility per ISO 10993-10.

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.

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 Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. (K051156)

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 the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: K 110945_ ." (applicant leave blank)

Premarket Notification [510(k)] Summary

C .. L __ ' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[(a)(a)( ) 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 :

| Submitter S name : | ZHAOYANG PLASTIC CO., LTD |
|--------------------------------|---------------------------------------------------------------|
| Submitter's address : | 37#.<br>SHENGLI RD. LIAOYANG CITY, LIAONING,<br>111000, CHINA |
| Phone number : | (86) 419-3669715 |
| Fax number : | (86) 419-3669638 |
| Name of contact person: | Mr. Wu Wei |
| Date the summary was prepared: | April 2nd, 2011 |

[(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<br>gloves |
|-------------------------|------------------------------------------------------------------|
| Proprietary/Trade name: | Powder-free yellow synthetic vinyl patient examination<br>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 |

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

Class I* Powder-free yellow synthetic vinyl patient examination gloves that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .

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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.

[(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 finger to prevent contamination 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.

| Characteristics | Standard | Device performance |
|-----------------------|-----------------------------------------|-----------------------------------------|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06<br>and D6124-01 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits | Passes<br>Not a Primary Skin Irritation |
| | Dermal sensitization in the guinea pig | Passes<br>Not a Dermal sensitization |

[(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, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

[(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 from the nonclinical 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 yellow synthetic vinyl patient examination gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AOL., meet labeling claims .

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

Zhaoyang Plastic Company. Limited C/O Mr. Chu Xiaoan RM 1606 Building 1, Jianxiang Yuan No 209 Bei Si Huan Zhong Road Haidian District, Beijing China 100083

SEP 1 3 2011

Re: K110945

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: August 12, 2011 Received: August 15, 2011

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. Ziaoan

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's issuance of a substantials with other requirements
mean that FDA has made a determination that your device with other requirements mean that FDA has made a determination inal your advisered by other Federal agencies.
of the Act or any Federal statutes and regulation, but not imited to: registration of the Act or any Federal statutes and regulations and limited to: registration
You must comply with all the Act's requirenents, including, but not limited to regorting You must comply with all the Act S requirements; care 801); medical device reporting
and listing (21 CFR Part 807); labeling (21 CFR 803); good manufacture and listing (21 CFR Part 807); labeling (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR Part 82 (reporting of medical device-related adverse events) (QS) regulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part practice requirements as set forth in the quality Systems (Sections 53) -542 of
and if applicable, the electronic product radiation control provisions (Sections 531-542 of
th the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
CDRHOIFICA (CDC Corporation (Alamara) (ContersOffices/CDRH/CDRHO/Fices/ucm If you desire specific advice for your device on our accures of any offices/nem
please go to http://www.fda.gov/AboutFDA/ContersOffices/close/if(ces/nem please go to http://www.lda.gov/Abouti-DA7ccities.org/file1senth's) Office of
115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of 115809.him for the Center for Devices and Italian entitled." Misbranding by reference to
Compliance. Also, please note the regulation entitled, "Misbranding the reporting Compliance. Also, please note the regulations regarding the reporting the reporting of
premarket notification" (21CFR Part 807.97). For questions regarding the reporting of premarket notification" (21CF R F ar 807:57). TER Part 803), please go to
adverse events under the MDR regulation (21 CFR Part 803), please go to adverse events under the MIJK regulation (2) CPN Park of Street States of the CDRH's
http://www.fda.gov/MedicalDevices/SafetyReportaProblem/default.html for the CDRH's
ess of http://www.fda.gov/MedicalDevices/Salety/Reports/
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
Office of Surveillance and Biometrics/Division of

You may obtain other general information on your responsibilities under the Act from the You may obtain other general international and Consumer Assistance at its toll-free
Division of Small Manufacturers, International and Consumer address Division of Small Manufacturers, Internet address
number [phone] or [phone] or at its Internet address
Counter [phone] or [phone] or at its lindus number [phone] of [phone] of at its inn.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cinthione, 20, 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: ZHAOYANG PLASTIC CO., LTD

## 510(k) Number (if known): * 1109 45

Device Name: Powder-free yellow synthetic vinyl patient examination gloves

Indications For 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 finger to prevent contamination between patient and examiner.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Cluara-Welch

Division of Anesthesiology, General Hospital Infection Control. Dental Devi

510(k) Numb