NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

K112693 · Sgmp Co., Ltd. · LYY · Sep 12, 2012 · General Hospital

Device Facts

• Record ID: K112693
• Device Name: NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of <50 ug/dm² per 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 yellow latex examination glove; features Tutti Frutti flavor; protein content labeled <50 ug/dm². Used in clinical settings by healthcare professionals to prevent cross-contamination between patient and examiner during examinations. Device acts as a physical barrier.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Latex. Form: Powder-free, yellow, flavored (Tutti Frutti). Protein content: <50 ug/dm². Non-sterile.

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.

Submission Summary (Full Text)

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

SGMP Company, Limited
C/O Ms. Janna P. Tucker
Tucker & Associates
198 Avenue De La D'Emerald
Sparks, Nevada 89434

SEP 12 2012

Re: K112693

Trade/Device Name: Non-Sterile, Powder-Free Yellow Latex Examination Gloves with Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm- Per Glove

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 19, 2012 Received: August 21, 2012

Dear Ms. Tucker:

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. Tucker

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/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/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 vours.

R. O'Shell
windett

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

## SGMP COMPANY LIMITED APPLICANT:

## K112693 510(K) NUMBER:

Non-Sterile; Powder-Free Yellow Latex Examination Gloves With Tutti DEVICE NAME: Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove

INDICATIONS FOR USE:

The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of <50 ug/dm² per 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.

Prescription Use (Part 21 CFR 801.Subpart D and/or

Over-The-Counter 21 CFR 801.Subpart C

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ralió banguhim

Division of Anesthesiology, General Hospitai Infection Control, Dental Devices

510(k) Number: K112643