NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)

K012166 · Best Manufacturing Company · LZA · Aug 1, 2001 · General Hospital

Device Facts

• Record ID: K012166
• Device Name: NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
• Applicant: Best Manufacturing Company
• Product Code: LZA · General Hospital
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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. Powder-free examination gloves are suitable in situations where powder is not desirable.

Device Story

Disposable nitrile rubber examination glove; provides barrier against body fluids and bloodborne pathogens; conforms to hand for fine movement; powder-free; brown color; ethylene acrylic acid copolymer accelerator/sulfur mixture. Used in clinical settings by healthcare providers to prevent cross-contamination. No natural rubber latex proteins.

Clinical Evidence

Bench testing only. Biocompatibility testing included rabbit irritation and guinea pig sensitization, both of which passed.

Technological Characteristics

Nitrile rubber; ethylene acrylic acid copolymer; powder-free; brown color; ASTM standards for watertightness and physical performance.

Indications for Use

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

• N-DEX Nitrile Powder-Free Medical Examination Glove (K992170)
• HPI Brown Nitrile Surgical Glove (K915086)

Submission Summary (Full Text)

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K012166

# AUG - 1 2001

510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29

## SUMMARY OF SAFETY AND EFFECTIVENESS

A. INFORMATION

1. SUBMITTER'S Name:

Address:

BEST MANUFACTURING COMPANY

579 Edison Street Menlo, GA 30731 USA

706 862 2302

2001-06-29

David C. Young

Nitrile Powder-Free Medical

Patient Examination Glove

Examination Glove

Examination Glove

Telephone Number:

Contact Person:

Date Summary Prepared:

2. NAME OF DEVICE Trade or Proprietary Name:

Common or Usual Name

Classification Name:

- 3. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
N-DEX Nitrile Powder-Free Medical Examination Glove, K992170; and HPI Brown Nitrile Surgical Glove, K915086

Non-Sterile Nitrile Powder-Free Patient

#### 4. DESCRIPTION OF DEVICE

- a. How the device functions: Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.
- b. Scientific concepts that form the basis for the device:

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.

- c. Physical and performance characteristics such as design, materials, and physical properties:
Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.

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K012166

510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29

- 5. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASE OR CONDITIONS THAT THE DEVICE WILL ADDRESS 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. Powder-free examination gloves are suitable in situations where powder is not desirable.
- 6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed device is identical to the predicate device, except for the following:

The proposed device has been rendered brown in color, like predicate K915086, while predicate K992170 is blue. The cherry flavor in predicate K992170 has been removed and the accelerator/ sulfur mixture in predicate K992170 has been replace with ethylene acrylic acid copolymer.

#### B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS

| Specification | Proposed<br>N-DEX Nitrile Powder-<br>Free Medical Examination<br>Glove (brown) | Predicate<br>N-DEX Nitrile Powder-<br>Free Medical Examination<br>Glove (blue) & HPI Brown<br>Nitrile Surgical Glove |
|--------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Performance<br>Standards | ASTM | ASTM |
| Watertightness | ASTM | ASTM |
| 2. DISCUSSION OF CLINICAL TESTS | | |
| Specification<br>Safety | Proposed | Predicate |
| Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Modified Draze Test<br>(Human Study) | N/A | Passes (predicate<br>K992170) |

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510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29

DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED ( with specific reference to adverse effects and complications)

See Section M: Biocompatibility Testing.

# 3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT

The Nitrile Powder-Free Medical Examination Glove (brown) has been carefully compared to a legally marketed device in the 510(k). The data summaries indicate that the proposed product meets or exceeds accepted scores for the predicate product in both physical and nonclinical tests and satisfies the requirements for a safe and effective "powder-free" medical glove.

Pursuant to 21 C.F.R. 807.87 (j), I David C. Young, Director, Regulatory Affairs and Quality Assurance, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Director, Regulatory Affairs and Quality Assurance, for the Best Manufacturing Company, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.

David C. Young, Director, Regulatory Affairs & Quality Assurance

2001-06-29 DATE

Young, Director, atory Affairs & Quality Assurance

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2001

Mr. David C. Younq Director of Regulatory Affairs & Quality Assurance Best Manufacturing Company Corporate HeadQuaters 579 Edison Street Menlo, Georgia 30731

Re : K012166 Trade/Device Name: Nitrile Powder-Free Medical Examination Glove (Brown) Requlation Number: 880.6250 Requlatory Class: I Product Code: LZA June 29, 2001 Dated: Received: July 11, 2001

Dear Mr. Young:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Mr. Young

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Whitaker

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29

### INDICATIONS FOR USE

Best Manufacturing Company Applicant: 510(k) Number (if known) Device Name: Nitrile Powderical Examination Glove (brown)

The Nitrile Powder-Free Medical Examination Glove (brown) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

* For a new submission, do NOT fill in the 510(k) number blank.

Olin S. Lirn

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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K012166