NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES

K112012 · Ug Healthcare (Usa), Inc. · LZA · Mar 21, 2012 · General Hospital

Device Facts

• Record ID: K112012
• Device Name: NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
• Applicant: Ug Healthcare (Usa), Inc.
• Product Code: LZA · General Hospital
• Decision Date: Mar 21, 2012
• Decision: SESE
• Submission Type: Traditional
• 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 the patient and the examiner.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; worn on examiner's hand; prevents cross-contamination between patient and examiner. Used in clinical settings. Manufactured from nitrile; features beaded cuff. Meets ASTM D6319-10 standards for physical properties and water-tightness. Available in sizes XS-XL. Provides barrier protection for healthcare personnel.

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, ultimate elongation), 1000ml water-tight testing (before and after aging), and residual powder content analysis. All results met ASTM D6319-10 requirements.

Technological Characteristics

Material: Nitrile. Design: Beaded cuff, powder-free. Standards: ASTM D6319-10, ISO 2859-1, ISO 9001:2008, ISO 13485:2003. Physical properties: Tensile strength >= 14.0 MPa, ultimate elongation >= 500% (before aging). Protein labeling claim < 50ug/g.

Indications for Use

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

• Nitrile Powder-Free Examination Gloves (K000689)

Submission Summary (Full Text)

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K112012

# SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue

MAR_2 1 2012

## Submission Applicant: UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa. Ca. 92626

Official Correspondent: Kenneth J. Stanton,President UG Healthcare (USA) Inc. 1565 Sunflower Avnue Costa Mesa, Ca 92626 . Tel: [phone] Fax: [phone]

Trade Name: Non-Sterile, Description of the Device Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue

- A. Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 2: Powder-Free Nitrile examination glove 80LZA that meets all of the requirements of ASTM D6319-10. *Predicative Devices: Nitrile Powder-Free Examination Gloves
Intended Use of the Device: 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 the patient and the examiner.

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## SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Glove Blue

#### Summary of Technological Characteristics:

Cuff: Beaded Material: Nitrile

Powder Residue: Maximum 2mg/glove

Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003

Inspection Parameters:

| Criteria | Inspection Level | AQL |
|-------------------------|------------------|-----|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |

## Physical Properties:

| Dimensions: |
|-----------------|
| Overall Length: |
| Width: |
| Thickness: |

240 mm minimum 95 mm minimum (for medium glove) .05 mm minimum

## BEFORE AGING

AFTER AGING

Tensile Strength: 14.0. Mpa minimum Ultimate Elongation:500% minimum

14.0 Mpa minimum 400% minimum

#### Special Properties: None

Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case

Sizes: XS — XL

Conclusion: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue meets the physical property requirements of ASTM D 6319-10, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at <50ug/g. This product is as safe, as effective, and performs as well or better than the legally marketed 510 #K000689. It has been supported by results of Biocompatibility Tests, Residual Powder Content tests, Physical Property Tests and the 1000ml Water Tight Test.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

MAR 2 1 2012

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

Mr. Ken Stanton President UG Healthcare (USA), Incorporated 1565 Sunflower Avenue Costa Mesa, California 92626

Re: K112012

Trade/Device Name: Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 28, 2012 Received: March 1, 2012

Dear Mr. Stanton:

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. Stanton

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 yours.

Anthony

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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# 510k Submission for: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue

3.0 Indications for Use:

112012 210K

Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue

Indications for Use - Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) and/or Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clavine William

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:_K1120/2