TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO

K123026 · Northstar Healthcare Holdings · LYY · Nov 16, 2012 · General Hospital

Device Facts

• Record ID: K123026
• Device Name: TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
• Applicant: Northstar Healthcare Holdings
• Product Code: LYY · General Hospital
• Decision Date: Nov 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The Latex Powder Free Examination Glove is a Disposable device intended for medical and dental purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Textured, blue, powder-free latex examination gloves; intended for medical and dental use to prevent cross-contamination between patient and examiner. Device worn on hand or finger; single-use. Manufactured from latex; meets ASTM standards for physical properties, dimensions, pinhole resistance, and protein content (≤50µg/dm2). Used in clinical or dental settings by healthcare professionals. Provides barrier protection; reduces risk of contamination during examinations.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM D3578-05 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), ASTM D5712-10 (protein levels), and ISO 10993-10:2010 (biocompatibility/skin irritation/sensitization).

Technological Characteristics

Material: Latex. Form: Textured, blue, powder-free, non-sterile. Dimensions/Properties: Meets ASTM D3578-05. Protein content: ≤50µg/dm2 (ASTM D5712-10). Biocompatibility: ISO 10993-10:2010 compliant. Single-use.

Indications for Use

Indicated for use as a disposable medical/dental 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.

Predicate Devices

• Latex Powder Free Examination Gloves (K062917)

Submission Summary (Full Text)

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K123026

Section 5, 510(k) Summary

Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves

ട്. 510(k) SUMMARY

DATE:

OWNER:

OFFICIAL CORRESPONDENT:

February 17, 2012

Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland

Michael Riordan Operations Manager Telephone: [phone] Fax: [phone] Email: [e-mail]

DEVICE NAME:

Trade Name: Textured, Blue, Latex, Powder Free Examination Gloves with Protein Labeling Claim (50ug/dm2 Or Less of Water Soluble Protein)

Common Name: Patient Examination Gloves

Classification: Patient Examination Gloves

Class I

Class:

LYY Product Code: Regulation: 880.6250

#### PREDICATE DEVICE(S):

| Predicate<br>510(k) | Device Name | Indication | Clearance<br>Date | Company |
|---------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------|
| K062917 | Latex Powder Free<br>Examination Gloves | The latex examination glove is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hand to prevent contamination between<br>patient and examiner. | 02 Nov 2006 | Wear Safe SDN,<br>BHD |

DEVICE DESCRIPTION: Textured, Blue, Latex, Powder Free Examination Gloves with Protein Labeling Claim (50µg/dm2 Or Less of Water Soluble Protein)

**NOV** 1 6 2012

Page 1 of 3

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Abbreviated 510(k) Premarket Notification
Latex Powder Free Examination Gloves

K123026

Section 5, 510(k) Summary
Page 2 of 3

## STATEMENT OF INTENDED USE:

The Latex Powder Free Examination Glove is a Disposable device intended for medical and dental purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## TECHNOLOGICAL CHARACTERISTICS:

The Latex Powder Free 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 latex using similar manufacturing processes.

| Feature | Latex Powder Free Examination Gloves<br>K062917<br>Predicate | Latex Powder Free Examination Gloves<br>(Proposed) | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | Intended for medical purposes that is worn on the<br>examiner's hand to prevent contamination between<br>patient and examiner. | Same | |
| Indications for<br>Use Statement | The latex examination glove is a disposable device<br>intended for medical purposes that is worn on the<br>examiner's hand to prevent contamination between<br>patient and examiner. | The latex examination glove is a disposable device<br>intended for medical purposes that is worn on the<br>examiner's hand or finger to prevent contamination<br>between patient and examiner. | |
| Description | Powder free, examination gloves made of latex. The<br>gloves are provided in sizes small, medium, large and<br>extra large. | Powder free, examination gloves made of latex and colored<br>blue. The gloves are provided in sizes small, medium,<br>large and extra large. | |
| Presentation | Non-Sterile gloves are provided in dispenser boxes. | Same | |
| Material | Latex | Same | |
| Single Use | Yes | Same | |
| Dimensions | Meets ASTM D3578-05 | Length Small, Medium, Large, XL<br>Width Small<br>Medium<br>Large<br>XL<br>Thickness Finger<br>Palm | 285 mm, min.<br>70-90mm<br>85-105 mm<br>101-121 mm<br>105-125 mm<br>0.30 mm min.<br>0.20 mm min. |
| Physical<br>Properties | Meets ASTM D3578-05 | Before aging/after aging<br>Elongation 650% 500%<br>Tensile Strength 18MPa 14MPa | |
| Freedom from<br>Pinholes | Meets ASTM D5151-06 | Same | |
| Residual Powder | Meets ASTM D6124-06 | Same | |
| Protein Level | Meets ASTM D5712-05 | Meets ASTM D5712-10 | |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits<br>Tests Passes Guinea Pig Maximization | Same | |

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K123026

Section 5, 510(k) Summary

Page 3 of 3

Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves

## ASSESSMENT OF NONCLINICAL DATA:

| Characteristic | Standard | Device<br>Performance |
|--------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------|
| Dimension | ASTM Standard D3578-05 | Meets |
| Physical Properties | ASTM Standard D3578-05 | Meets |
| Freedom from<br>Pinholes | 21 CFR 800.20; ASTM<br>D5151-06 | Meets |
| Powder Residual | ASTM Standard D6124-06 | Meets<br>Results generated<br>values below 2mg<br>of residual powder |
| Protein Level | ASTM Standard 5712-10 | Meets<br>Results generated<br>values below 50<br>mcg/g of protein |
| Biocompatibility | Primary Skin Irritation in<br>rabbits<br>(ISO 10993-10:2010) | Gloves are non-<br>irritating |
| | Dermal Sensitization in the<br>guinea pig (ISO 10993-<br>10:2010) | Gloves do not<br>display any<br>potential for<br>sensitization |

## CONCLUSIONS:

The Latex Powder Free Examination Gloves meet the requirements of established standards ASTM D3578-05, ASTM D5712-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010.

Based on the comparison of intended use, design, materials and performance, the Latex Powder Free Examination Gloves are substantially equivalent to the predicate device.

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### November 16, 2012

Northstar Healthcare Holdings C/O Mr. Ned Devine Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K123026

Trade/Device Name: Textured, Blue, Latex, Powder Free Examination Gloves with Protein Labeling Claim (50μg/dm2 Or Less of Water Soluble Protein)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 25, 2012 Received: October 31, 2012

Dear Mr. Devine:

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. 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 (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

1. Hony 12 1 12-12-

DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anthony D. Watson. 0.9.2342.19200300.100.1.1=1300092402

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

0.9.2342.19200300.100.1.1=1300092402

DN: c=US, o=U.S. Government, c
ou=FDA, ou=People, cn=Anthor
Watson,
0.9.2342.19200300.100.1.1=1300

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# INDICATIONS FOR USE

# 510(k) Number (if known): 143024

Device Name:

Textured, Blue, Latex, Powder Free Examination Gloves with Protein Labeling Claim (50ug/dm2) Or Less of Water Soluble Protein)

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.

#### AND/OR

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Digitally signed by Elizabeth F. Claverie Date: 2012.11.16 1/2:42:41 -05'00'

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

**510(k) Number:** K123026

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