SHENGKUN CHEMICAL

K110621 · Zibo Shengkun Chemical Industrial Co., Ltd. · LYZ · Aug 24, 2011 · General Hospital

Device Facts

• Record ID: K110621
• Device Name: SHENGKUN CHEMICAL
• Applicant: Zibo Shengkun Chemical Industrial Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Synthetic Vinyl Examination Glove, Powder Free 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

Synthetic vinyl examination gloves; disposable; powder-free. Worn on examiner's hand or finger. Acts as a physical barrier to prevent cross-contamination between patient and examiner during medical examinations. Used in clinical or medical settings by healthcare professionals. No electronic components, software, or algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic vinyl material; powder-free; disposable; physical barrier; non-sterile; manual application.

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 use in medical settings.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol consisting of three curved lines, which is meant to represent the human form.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jason Liu Factory Manager Zibo Shengkun Chemical Industrial Company, Limited Fine Chemical Park, Chemical Industry Park Zibo, Shandong Zibo, Shandong China 255400

AUG 2 4 2511

Re: K110621

K 110021
Trade/Device Name: Synthetic Vinyl Examination Gloves, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 11, 2011 --Received: August 18, 2011

Dear Mr. Liu:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 710(t) promainte is substantially equivalent (for the referenced above and nave decembine the concessed predicated predicate devices marketed in
indications for use stated in the enclosure , a notested of the Medical Device indications for use stated in the encrysis the enactment date of the Medical Device interstate commerce proof to May 20, 1970, the sideed in accordance with the provisions of
Amendments, or to devices that have been receives approval of a premarket Amendments, or to devices that have been results approval of a prematice approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do subject to the general the Federal Food, Drug, and Cosment Act (roc) market the device, subject to the general
approval application (PMA). You may, therefore, market the devices subject to the gen approval application (FMFA). Tou may, includes provisions of the Act include controls provisions of the Act. The genting of devices, good manufacturing practice, requirements for annual registration, fishing and adulteration. Please note: CDRH does
labeling, and prohibitions against misbranding and adulteration. Novever, labeling, and promotions against inisoftanting alle assessmites. 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 If your device is classined (see above) into entrely (sp) regulations affecting your
(PMA), it may be subject to additional controls. Exist (Sparts 800 to 898 In (PMA), it may be subject to adultional controller and governments on the Peders device can be found in the Code of I cacra. Regulations, one of the Federal Register.

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## Page 2 - Mr. Liu

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's issuance of a substantial examples with other requirements
mean that FDA has made a determination that your device with other Federal agencies. mean that FDA has made a determinations administered by other Federal agencies.
of the Act or any Federal statutes and regulations and including, by not imited to: registrati of the Act or any Federal statutes and regulations annualing, but not limited to: registration
You must comply with all the Act of a con Re- 801): medical device reporting You must comply with all the Act Siequitements, and 801); medical device reporting
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting and listing (2) CFR Part 807); labeling (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of medical device-related adverse events) (2) egulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 -542 of practice requirements as set forth in the quality systems (2) 1988.
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), a If you desire specific advice for your actives on on and fices/CDRHOffices please go to http://www.ida.gov/Aboution.com/Radiological Health's (CDRH's) Office of
/ucm I 15809.htm for the Center for Devices and Radiological Health and /ucm] 15809.htm for the Center for Devices not titled, "Misbranding by reference to Compliance. Also, please note the regulations regarding the reporting of
premarket notification" (21CFR Part 807.97). For questions regarding the reporting of premarket notification (21CFR r at 807.97) PCFR Part 803), please go to
adverse events under the MDR regulation (21 CFR Part 803), please go to adverse events under the MDK regulation (27 erreral voor)/default.htm for the CDRH's
http://www.fda.gov/MedicalDevices/SSS:tty/ReportsProblem/def Surveillance. http://www.fda.gov/MedicalDevices/Division of Postmarket Surveillance.
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general mionnational on "Openone" Assistance at its toll-free
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sinan Manufactarers) - 100 or at its Internet address
number [phone] or [phone] or asferYou/Industry/def number [phone] of [phone] er urns - 100 er and - 1000 er - 1000 er - 1000 en - 1

Sincerely yours,

Cathony O. m

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

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Synthetic Vinyl Examination Gloves, Powder-Free

Indications For Use: Synthetic Vinyl Examination Glove, Powder Free 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 Use (Parl 21 CFR 801 Subpart D)

AND/OR

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

(Please do not write Below This Line-Continue on another page if

NEEDED)

Sree Rumore

Kilolat

(Division Sign-Off) Division of Anesthesiology, @meratelospital RH, Office of Device Evaluation (ODE) Infection Control, Dental Devices

510(k) Number:

Tel:[phone]