NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)

K030075 · Best Manufacturing Company-Distribution Center · LZA · Mar 5, 2003 · General Hospital

Device Facts

• Record ID: K030075
• Device Name: NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
• Applicant: Best Manufacturing Company-Distribution Center
• Product Code: LZA · General Hospital
• Decision Date: Mar 5, 2003
• 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; worn on examiner's hand; provides barrier against body fluids and bloodborne pathogens; prevents cross-contamination between patient and examiner. Device conforms to hand for fine motor movement; powder-free; latex-free. Used in clinical settings by healthcare professionals. Output is physical barrier protection.

Clinical Evidence

No clinical data. Safety established via non-clinical biocompatibility testing including rabbit irritation and guinea pig sensitization studies, which passed.

Technological Characteristics

Nitrile rubber material; textured or non-textured surface; powder-free. Complies with ASTM standards for performance and watertightness. Non-sterile.

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.

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

• Blue Nitrile Powder-Free Medical Examination Glove (K992170)
• Nitrile Powder-Free Medical Examination Glove (brown) (K012166)

Submission Summary (Full Text)

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K030075

510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24 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

David C. Young

Examination Glove

Telephone Number:

Contact Person:

Date Summary Prepared: 2002-12-24

- 2. NAME OF DEVICE Nitrile Powder-Free Medical Trade or Proprietary Name:
Common or Usual Name

Non-Sterile Nitrile Powder-Free Patient Examination Glove

Classification Name: Patient Examination Glove

- Blue Nitrile Powder-Free Medical 3. PREDICATE DEVICE Examination Glove, K992170; and IDENTIFICATION NAME, NUMBER Nitrile Powder-Free Medical Examination Glove (brown), K012166
## 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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510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-240

## 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 formula for the modified device does not contain the cherry flavor and the accelerator/sulfur mixture as found in the predicate K992170. The cherry flavor has been eliminated completely, with no replacement. The accelerator/sulfur mixture has been replaced by WE4-25A ethylene acrylic acid copolymer, as used in predicate K012166.

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

| Specification | Proposed<br>Nitrile Powder-Free<br>Medical Examination<br>Glove (blue), textured<br>and non-textured | Predicate<br>Blue Nitrile Powder-Free<br>Medical Examination<br>Glove & Nitrile Powder-Free<br>Medical Examination Glove<br>(brown) |
|---------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Standards | ASTM | ASTM |
| Watertightness | ASTM | ASTM |
| 2. DISCUSSION OF CLINICAL TESTS | | |
| Specification | Proposed | Predicate |
| Safety<br>Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Modified Draze Test | N/A | N/A |

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510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24

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 (blue) 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 Ouality 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

2002-12-24
DATE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

Public Health Service

MAR 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030075

Trade/Device Name: Nitrile Powder-Free Medical Examination Gloves, Blue Textured and Non-textured Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: December 24, 2002 Received: January 8, 2003

Dear Mr. Young:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Young

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), ' please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Rempen

Susan Runner, DDS, MA Interim 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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510(K) SUBMISSION FOR BLUE NTTRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24

#### INDICATIONS FOR USE

Applicant: Best Manufacturing Company 510(k) Number (if known) Device Name: Nitrile Powder-Free Medical Examination Glove (blue) Textured of Nortextured The Nitrile Powder-Free Medical Examination Glove (blue) 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. Lim

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

510(k) Number. K030025

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