BLUE POWER FREE NITRILE EXAMINATION GLOVE

K121464 · Northstar Healthcare Holdings · LZA · Jul 5, 2012 · General Hospital

Device Facts

• Record ID: K121464
• Device Name: BLUE POWER FREE NITRILE EXAMINATION GLOVE
• Applicant: Northstar Healthcare Holdings
• Product Code: LZA · General Hospital
• Decision Date: Jul 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The 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.

Device Story

Blue powder-free nitrile patient examination glove; disposable; worn on examiner's hand or finger. Prevents cross-contamination between patient and examiner during medical and dental procedures. Tested for use with chemotherapy drugs. Manufactured from nitrile; meets ASTM D6319 standards for physical properties and dimensions. Used in clinical or dental settings by healthcare professionals.

Clinical Evidence

Bench testing only. Performance verified against ASTM D6319 (dimensions, physical properties), ASTM D5151 (freedom from pinholes), and ASTM D6124 (powder residual). Biocompatibility testing conducted per ISO 10993-10, including primary skin irritation and dermal sensitization studies in animal models, confirming the device is non-irritating and non-sensitizing.

Technological Characteristics

Material: Nitrile. Form factor: Blue, powder-free, disposable patient examination glove. Standards: ASTM D6319 (dimensions/physical properties), ASTM D5151 (pinholes), ASTM D6124 (powder residual), ISO 10993-10 (biocompatibility). 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 in medical and dental 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.

Predicate Devices

• Nitrile Powder Free Examination Gloves (Blue, White) (K071119)

Submission Summary (Full Text)

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#### K121 464

Abbreviated 510(k) Premarket Notification Blue Powder Free Nitrile Patient Exam Glove

#### Section 5, 510(k) Summary Pagc S-1

#### 510(k) SUMMARY 5 JUL 5 2012 DATE: March 5, 2012 OWNER: Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland OFFICIAL Alex Nagy CORRESPONDENT: Manager, Quality Systems and Regulatory Affairs Cypress Medical Products LLC 1200 South Route 31 McHenry, IL 60050 Telephone: [phone] Fax: [phone] Blue Powder Free Nitrile DEVICE NAME: Trade Name: Examination Glove Common Name: Patient Examination Gloves Classification : Patient Examination Gloves Class: Class I . Product Code: LZA PREDICATE DEVICE(S):

| Predicate<br>510(k) | Device Name | Indication | Clearance<br>Date | Company |
|---------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------|
| K071119 | Nitrile Powder<br>Free<br>Examination<br>Gloves (Blue,<br>White) | The examination gloves is a disposable device<br>intended for medical and dental purposes that is<br>worn on the examiner's hand to prevent<br>contamination between patient and examiner. | 24 Jul 2007 | GX<br>Corporation<br>SDN BHN,<br>Selangor<br>Darul<br>Ehsan,<br>Malaysia |

Northstar Healthcare Holdings - Confidential

.

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Abbreviated 510(k) Premarket Notification Blue Powder Free Nitrile Patient Exam Glove

DEVICE DESCRIPTION:

STATEMENT OF

INTENDED USE:

Powder free blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

The nitrile examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

# TECHNOLOGICAL CHARACTERISTICS:

The Blue Powder Free Nitrile Examination Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with Nitrile using similar manufacturing processes.

# ASSESSMENT OF NONCLINICAL DATA:

| Characteristic | Standard | Device Performance |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D5151 & ASTM D6319 | Meets |
| Powder Residual | ASTM D6124 | Meets<br>Results generated<br>values below 2mg of<br>residual powder |
| Biocompatibility | Primary Skin Irritation in rabbits<br>(ISO 10993-10)<br><br>Dermal Sensitization in the guinea<br>pig (ISO 10993-10) | Gloves are non-<br>irritating<br><br>Gloves do not display<br>any potential for<br>sensitization |

### CONCLUSIONS:

The Blue Powder Free Nitrile Patient Exam Glove meet the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10.

Based on the comparison of intended use, design, materials and performance, the Blue Powder Free Nitrile Patient Exam Glove are substantially equivalent to the predicate device.

#### Northstar Healthcare Holdings - Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three diagonal lines that form a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

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

SEP 2 0 2012

NorthStar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K121464

Trade/Device Name: Blue Powder Free Nitrile Patient Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 20, 2012 Received: June 21, 2012

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of July 5, 2012.

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 (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.

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 Devine

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

For Beth Simmons

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

# 510(k) Number (if known): _K12 / 464

Blue Powder Free Nitrile Patient Exam Glove Device Name:

Indications for Use: The 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _ I of _1

Elizabeth D. Clamin-Willis

:Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

::10(k) Number: ______________________________________________________________________________________________________________________________________________________________

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