(174 days)
Not Found
No
The device description and intended use clearly define a physical surgical glove, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is described as a barrier to prevent contamination, not to treat or cure a medical condition.
No
Explanation: The device is a surgical glove intended to provide a barrier against infectious materials and contaminants, not to diagnose medical conditions.
No
The device description clearly identifies the device as a physical glove made of natural rubber latex, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "barrier against potentially infectious materials and other contaminants" worn on the hands in surgical settings. This describes a physical barrier device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a "Surgeon's Glove," which is a personal protective equipment (PPE) item.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are typically used in laboratories or point-of-care settings to test blood, urine, tissue, or other bodily fluids. This device is a physical barrier used during surgical procedures.
N/A
Intended Use / Indications for 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.
Product codes
KGO
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Double™ Glove characteristics are summarized below compared to ASTM requirements and to the predicate device.
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
The performance data are the same as summarized.
Clinical data not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).
0
510(k) Summary
Owner Information:
BioBarrier, Inc.
12104 Bonny Lane
Los Angeles, CA 90049
Phone: 310-472-7170
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 |
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.
1
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
3
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