NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES

K093516 · Summit Glove, Inc. · LZA · Jun 29, 2010 · General Hospital

Device Facts

• Record ID: K093516
• Device Name: NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
• Applicant: Summit Glove, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jun 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

This is a disposable device intended for medical purposes: that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

Device Story

NitriTech® is a non-sterile, powdered nitrile examination glove. Used by healthcare professionals in medical and dental settings to provide a protective barrier on the hands. The glove acts as a physical barrier to prevent contamination between the patient and the examiner. It is a disposable, single-use device.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM D6319-00a, including hole detection (ASTM D5151), physical dimensions, tensile strength/elongation (ASTM D412/D573), and powder content (ASTM D6124-06). Biocompatibility confirmed via Primary Skin Irritation (CPSC Title 16) and Dermal Sensitization (ISO 10993-10) with scores indicating no irritation or hypersensitivity.

Technological Characteristics

Material: Nitrile rubber. Form factor: Powdered examination glove. Standards: ASTM D6319-00a (physical properties, dimensions, barrier integrity). Biocompatibility: ISO 10993-10, CPSC Title 16 Part 1500. Non-sterile.

Indications for Use

Indicated for medical and dental use as a protective barrier 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

• Non-Sterile Powder Free Nitrile Examination Gloves (K090828)

Submission Summary (Full Text)

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## 510K Summary

# 510K: K093516

JUN 29 2010

#### 1. Information

| a. Submitter's | |
|-----------------|------------------------|
| Name: | Summit Glove Inc. |
| Address: | 310 South Grant Street |
| | Minerva, Ohio 44657 |
| Phone: | 330-868-0066 |
| Contact Person: | James Moore |
| E-mail: | [e-mail] |

## 2. Name of Device

| Trade or Proprietary Name: | NitriTech®, Non-Sterile Powdered Nitrile Examination Glove in the color blue |
|----------------------------|------------------------------------------------------------------------------|
| Common or Usual Name: | Synthetic Rubber Examination Gloves |
| Classification Name: | Patient Examination Glove, Powdered |

3. Predicate Device: Non-Sterile Powder Free Nitrile Examination Gloves Submission Number: K090828. Based on the below test results, it is concluded the subject gloves are a substantial equivalent to the predicate device.

#### 4. Identification of the Legally Marketed Devices

Powdered Nitrile Examination Gloves as described in this 510K Notification is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets the current specifications listed under the ASTM Specification D6319-00a, Standard for Nitrile Gloves for Medical Application.

#### 5. Description of Device

Powdered Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 6. Intended Use of Gloves

This is a disposable device intended for medical purposes: that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

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## 7. Summary of Performance Data:

Performance data of gloves based is on ASTM D6319-00a. ASTM D6319-00a Section 9 is inapplicable for non-sterile examination grade nitrile gloves.

:

| Test | ASTM 6319-00a | Powdered Nitrile Examination Gloves | |
|------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------|-----------------|
| 1. Detection of Holes (ASTM 5151) | Multiple Normal G1 AQL = 2.5 | Pass G1 AQL = 2.5* | |
| 2. Length (mm)<br>Size XS | Min 220 - | 240 mm minimum for all sizes * | |
| S | Min 220 - | | |
| M | Min 230 - | | |
| L | Min 230 - | | |
| XL | Min 230 | | |
| 3. Palm Width (mm)<br>Size XS | 70 ± 10 | 73-78 | |
| S | 80 ± 10 | 83-88 | |
| M | 95 ± 10 | 93-98 | |
| L | 110 ± 10 | 104-109 | |
| XL | 120 ± 10 | 111 - 118 * | |
| 4. Thickness (mm)<br>Finger | Min 0.05 | Min 0.06 | |
| Palm | Min 0.05 | Min 0.05 * | |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (Mpa) | Min 14 | 18 - 33 | |
| Ultimate Elongation (%) | Min 500 | 500 - 630* | |
| After Aging<br>Tensile Strength (Mpa) | Min 14 | 18 - 33 | |
| Ultimate Elongation (%) | Min 400 | 500 - 610 * | |
| 6. Powder Content | Maximum is not Stated | Max 120mg/glove * | |
| 7. | Primary Skin Irritation CPSC<br>Title 16 Chapter II Part 1500 | PII Greater or equal to 5.0<br>indicates an irritate | PII was "0.04"* |
| 8. | Dermal Sensitization Test ISO<br>10993-10 | Score greater or equal to<br>1 indicates<br>irritation/hypersensitivity | Score was "0"* |

* Third Party test data is available in Appendix A

·

:

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The performance data of the gloves as shown above meet the ASTM D6319-00a Standard using the following test methods:

- o ASTM D412 Tensile Properties Unaged Test Method A
- o ASTM D573 Tensile Properties Aged
- o ASTM D5151 Detection of Holes
- o ASTM D6124-06 Section 7 Procedure II for Powdered Gloves
- 8. The Biocompatibility Test consists of Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) and Dermal Sensitization Tests (ISO 10993-10).

* Third Party test data is available in Ammendment E

The conclusion of the Biocompatibility Testing would indicate that there is no irritation or hypersensitivity to the subject gloves (NitriTech® Non-Sterile Powdered Nitrile Examination Gloves in the color blue).

## 9. Conclusion:

It is concluded that the NitriTech® Non-Sterile Powdered Nitrile Examination Gloves in the color blue for this submission meets ASTM D6319-00a, CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements.

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## Statement concerning the Biocompatibility Testing

The gloves tested in the Biocompatibility Testing were the subject glove (NitriTech®, Non-Sterile Powdered Nitrile Examination Gloves in the color blue) of this submission. Mediamal Testing and Consultancy Services had the Primary Skin Irritation (study report # MB-PSI-26-09) and Dermal Sensitization Test (study report # MB-DSAb-26-09) completed to CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 standards.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

Mr. James Moore Project Coordinator Summit Glove, Incorporated 310 South Grant Street Minerva, Ohio 44657

# JUN 2 9 2010

Re: K093516

Trade/Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 10, 2010 Received: June 15, 2010

Dear Mr. Moore:

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. Moore

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/CentersQffices/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/ReportalProblem/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,

Susan Wunner

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): K093516

Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue.

Indications For Use:

The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

AND/OR Over-The-Counter Use _ Prescription Use X (Part 21 CFR 801 Subpart D) (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)

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

k093516 510(k) Number: _