NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K112005 · Ug Healthcare (Usa), Inc. · LYY · Mar 21, 2012 · General Hospital

Device Facts

• Record ID: K112005
• Device Name: NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Ug Healthcare (Usa), Inc.
• Product Code: LYY · 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

Non-sterile, powder-free, green latex examination gloves; intended for use by healthcare professionals to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. Manufactured from latex with a beaded cuff; powder residue limited to 2mg/glove; protein content labeled at 50 micrograms or less per gram. Used in clinical settings; disposable. Benefits include protection against contamination while maintaining physical properties (tensile strength, elongation) compliant with ASTM D3578-10 standards.

Clinical Evidence

Bench testing only. Evidence includes physical property testing (tensile strength, elongation before/after aging), 1000ml water-tight testing, residual powder content analysis, and biocompatibility testing. All results met ASTM D3578-10 requirements.

Technological Characteristics

Material: Latex. Cuff: Beaded. Powder residue: Max 2mg/glove. Protein content: <50ug/g. Compliance: ASTM D3578-10, ISO 2859-1:1999, ISO 9001:2000, ISO 13485. Physical properties: Tensile strength (min 18.0 MPa before aging, 14.0 MPa after), Ultimate elongation (min 650% before, 500% after). Dimensions: 240mm length, 0.08mm thickness.

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. Suitable for general medical examination use.

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

• Latex Powder-Free Examination Gloves (K010881)

Submission Summary (Full Text)

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K112005

MAR 2 1 2012

SUMMARY PREMARKET 510(k) NO.TIFICATION Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim

Submission Applicant -

UG Healthcare (USA) Inc 1565 Sunflower Avenue Costa Mesa, Ca. 92626

Official Correspondent -

Kenneth J. Stanton 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: [phone] Fax: [phone]

Submitted: July 7, 2011

Description of the Device: Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim

Trade Name: Various

Common Name: Examination Gloves A. Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-10. Predicative Devices: Latex 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.

SUMMARY PREMARKET 510(k) NOTIFICATION for - Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim

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K 112005

#### Summary of Technological Characteristics:

Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove In compliance with ASTM D3578-10, ISO 2859-1:1999, Quality Assurance: manufactured under ISO9001:2000 and ISO 13485

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: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Thickness: | .08mm minimum |

#### BEFORE AGING

Tensile Strength: 18.0. Mpa minimum Ultimate Elongation:650% minimum

# AFTER AGING

14.0 Mpa minimum 500% minimum

#### Special Properties: None

Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

Sizes: XS — XL

Conclusion: The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim meets the physical property requirements of ASTM D 3578-10, 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 #K010881. 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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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, a symbol of medicine, with a staff entwined by two snakes. The caduceus is oriented vertically, with the staff pointing upwards.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

MAR 2 1 2012

Re: K112005

Trade/Device Name: Non- Sterile, Powder-Free, Green Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 23, 2012 · Received: February 24, 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,

es

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: 3.0

# 510K _ 112005

Device Name: Non-Sterile, Powder-Free, Green Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)

## Indications for Use - The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim

(50 micrograms or less total water extractable protein per gram of glove), 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)

Eliz.th F. Clamens-Wille
(Division Sign-Off)

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112005