GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE

K012899 · Best Manufacturing Company · LZA · Sep 18, 2001 · General Hospital

Device Facts

• Record ID: K012899
• Device Name: GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
• Applicant: Best Manufacturing Company
• Product Code: LZA · General Hospital
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Green Nitrile Powder-Free Medical Examination Glove 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).

Device Story

Disposable nitrile rubber examination glove; worn on examiner's hand to provide barrier against body fluids and bloodborne pathogens. Nitrile material conforms to hand for dexterity; latex-free to prevent protein allergen exposure. Used in clinical settings by healthcare providers. Device functions as physical barrier; no electronic or algorithmic components. Green color variant of predicate blue glove.

Clinical Evidence

No clinical trials performed. Evidence consists of non-clinical bench testing and biocompatibility studies. Bench testing confirmed compliance with ASTM standards for watertightness. Biocompatibility testing included rabbit irritation and guinea pig sensitization studies, which the device passed, demonstrating safety equivalent to the predicate.

Technological Characteristics

Nitrile rubber material; powder-free; disposable. Conforms to ASTM standards for physical properties and watertightness. Non-sterile. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a disposable medical examination 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

• N-DEX Nitrile Powder-Free Medical Examination Glove (K992170)

Submission Summary (Full Text)

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510(K) SUBMISSION FOR GREEN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (S SUBMISSION DATE: 2001-06-15

# SUMMARY OF SAFETY AND EFFECTIVENESS

### A. INFORMATION

1. SUBMITTER'S

Name:

BEST MANUFACTURING COMPANY

| Address: | 579 Edison Street<br>Menlo, GA 30731 USA |
|-------------------------------------------------|-----------------------------------------------------------------|
| Telephone Number: | 706 862 2302 |
| Contact Person: | David C. Young |
| Date Summary Prepared: | 2001-06-15 |
| 2. NAME OF DEVICE<br>Trade or Proprietary Name: | Nitrile Powder-Free Medical<br>Examination Glove (Green) |
| Common or Usual Name | Non-Sterile Nitrile Powder-Free Patient<br>Examination Glove |
| Classification Name: | Patient Examination Glove |
| 3. PREDICATE DEVICE<br>IDENTIFICATION NAME | N-DEX Nitrile Powder-Free Medical<br>Examination Glove, K992170 |

## 4. DESCRIPTION OF DEVICE

NUMBER

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 vields 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. PAGE I OF 3

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510(K) SUBMISSION FOR GREEN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-15

- 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 green in color, while the predicate is blue.

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

(Human Study)

| Specification | Proposed | Predicate |
|---------------------------------|-------------------------------------------------------------|------------------------------------------------------------|
| | N-DEX Nitrile Powder-Free Medical Examination Glove (green) | N-DEX Nitrile Powder-Free Medical Examination Glove (blue) |
| Performance Standards | ASTM | ASTM |
| Watertightness | ASTM | ASTM |
| 2. DISCUSSION OF CLINICAL TESTS | | |
| Specification | Proposed | Predicate |
| Safety | | |
| Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Modified Draze Test | N/A | Passes |

PAGE 2 OF 3

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510(K) SUBMISSION FOR GREEN NITRILE POWDER-FREF. MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-15

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 (green) 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. U

David C. Young, Director Regulatory Affairs & Quality Assurance

2001-06-15 DATE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 1 8 2001

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

Re: K012899

Trade/Device Name: Green Nitrile Powder-Free Medical Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 15, 2001 Received: August 29, 2001

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.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. Young

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 (section 534-542 of the Act; 21); CFR 1000-1050.

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 regulation (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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Los A. Walberto

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 GREEN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-15

#### INDICATIONS FOR USE

Best Manufacturing Company Applicant: 510(k) Number (if known) KO12899 Device Name: Green Nitrile Powder-Free Medical Examination Glove

The Green Nitrile Powder-Free Medical Examination Glove 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)

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Concurrence of CDRH Office of Device Evaluation (ODE) ાર Over-The-Counter______________________________________________________________________________________________________________________________________________________________ Prescription Use Per 21 CFR 801.109 * For a new submission, do NOT fill in the 510(k) number blank.

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