THE DOUBLE GLOVE

K060030 · Biobarrier, Inc. · KGO · Jun 27, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060030
• Device Name: THE DOUBLE GLOVE
• Applicant: Biobarrier, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The powderfree, polymer coated, sterile surgeon's glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Device Story

The Double™ Glove is a sterile, powder-free, natural rubber latex surgeon's glove featuring a Single-Donning™ design with two discrete layers fused at the wrist. Used in surgical settings by physicians and clinical staff, the device acts as a physical barrier to protect both the wearer and the patient from infectious materials and contaminants. The glove is donned as a single unit, providing the protection of a double-glove system without the complexity of donning two separate pairs. It benefits the patient and clinician by reducing the risk of cross-contamination and exposure to pathogens during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing confirming compliance with ASTM D 3577 standards for physical properties, dimensions, and freedom from holes, as well as successful biocompatibility testing (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Material: Natural rubber latex. Design: Single-donning double-layer fused at the wrist. Coating: Polymer. Standards: Meets ASTM D 3577 (Type I). Biocompatibility: Passed primary skin irritation and guinea pig sensitization tests. Sterilization: Sterile.

Indications for Use

Indicated for use as a disposable barrier on the hands of healthcare personnel in surgical settings to protect against infectious materials and contaminants. No specific age or gender restrictions; contraindicated for individuals with latex allergies.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Kanam Latex Industries Powder-free Latex Surgeon's Gloves Polymer Coated Sterile (K033564)

Submission Summary (Full Text)

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510(k) Summary

1.
Owner Information:
BioBarrier, Inc.
12104 Bonny Lane
Los Angeles, CA 90049
Phone: [phone]
JUN 27 2006
Contact:
David W. Mullis, Jr., Ph.D., RAC
Telephone:
779-207-9174
FAX:
770-207-7682
Date:
December 30, 2005
2.
Trade Name:
The Double™ Glove
Common Name:
Surgical Glove
Classification:
Surgeon's Glove 21CFR878.4461
Code:
79KGO
3.
Predicate Device:
-Class I Surgeon's Gloves, Powder-free
-Meets all ASTM D 3577 requirements
-Predicate: K033564, Kanam Latex Industries Powder-free Latex
Surgeon's Gloves Polymer Coated Sterile Contains 50 micrograms or
less of total water extractable protein per gram
4.
Device Description:
The Double™ Glove, a Single-Donning™ Double Glove with 2
Discrete Layers Fused at the Wrist. A Class I, Powder-free, Polymer
Coated, Latex Surgeon's Glove
5.
Intended Use:
The powderfree, polymer coated, sterile surgeon's glove is a disposable
device made of natural rubber latex that is intended to be worn on the
hands, usually in surgical settings, to provide a barrier against
potentially infectious materials and other contaminants.
6.
Technological Characteristics: The Double™ Glove characteristics are summarized below
compared to ASTM requirements and to the predicate device.

| Characteristic | Standard |
|-----------------------------------|---------------------------|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type I |
| Freedom from Holes | Meets ASTM D 3577 |
| Biocompatibility: | |
| Primary Skin Irritation (Rabbits) | Pass |
| Guinea Pig Sensitization | Pass |

7.
Performance Data:
The performance data are the same as summarized in No. 6, above.
8.
Clinical Data:
Clinical data not required.
9.
Conclusions:
The Double™ Glove meets the technological characteristics of ASTM D
3577 and is substantially equivalent to the predicate device and Class I,
powder-free, latex surgeon's gloves with a less than 50 microgram/gram
of water extractable protein claim.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 2006

Biobarrier, Incorporated C/O Dr. David W. Mullis Mullis & Associates, Incorporated 367 Pleasant Valley Road P.O. Box 39 Good Hope, Georgia 30641

Re: K060030

Trade/Device Name: Powder-Free, Polymer Coated, Sterile, Single Donning Double Layer, Surgeon's Glove Contains 50 Micrograms or Less of total Water Extractable Protein Per Gram

Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KG() Dated: June 5, 2006 Received: June 6, 2006

Dear Dr. Mullis:

We have reviewed your Section 510(k) premarket notification of intent to market the access referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices mai . 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 provision the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premement 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 - Dr. Mullis

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/industry/support/index.html.

Sincerely vours.

Ching-ju, Ph.D.

Chiu Lin. Ph.D. 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): K 060030

Applicant: BioBarrier, Inc.

Powder-free, polymer coated, sterile, single donning double layer, Device Name: surgeon's glove contains 50 micrograms or less of total water extractable protein per gram.

Indications for Use: The powder-free, polymer coated, sterile surgeon's glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stula H. Murphy, M.D.
4/2/02

-( : ) of Anesthesiology, General Hospital, Contici. Dental Device

Kalian 30