(72 days)
80LYZ
Not Found
No
The summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device is a patient examination glove, which serves as a barrier and is not intended for the treatment, diagnosis, or prevention of disease, which are characteristics of a therapeutic device.
No
The device is described as a glove intended to provide a barrier against infectious materials, not to diagnose a condition.
No
The device description clearly states it is a physical glove made of synthetic material, 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 "powder-free patient examination glove" intended to be worn on the hand or finger(s) for medical purposes to provide a barrier. This describes a physical barrier device used for protection, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description confirms it's a "Class II powder-free patient examination glove." This classification is consistent with a physical barrier device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic or monitoring information based on specimen analysis
- Reagents, calibrators, or controls
The information provided describes a medical device used for personal protection during medical procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product codes
LYZ
Device Description
Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Leaching and biocompatibility comparative studies between this device and legally marketed powder-free gloves demonstrate that this device is substantially equivalent to legally marketed vinyl powder-free gloves.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
12/17/03
BERNARD TECHNOLOGIES, INC.
- [1] 510(k) Summary
- [2] Bernard Technologies, Inc. 75 E. Wacker Dr. Chicago, IL 60601
Contact: Michael D. Lelah, PhD Telephone: 312-337-7007 Fax: 312-337-0505
October 1, 2003
- (Multiple labels) Powder-Free Vinyl Examination Gloves [3] Trade Name: Common Name: Powder-Free Vinyl Examination Gloves Classification Name: Patient Examination Gloves, powder-free
- [4] Legally marketed device to which equivalency is being claimed: Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
- Device Description: Class II powder-free patient examination glove 80LYZ, that meets િરો all of the requirements of ASTM standard D 5250-00.
- [୧] Intended Use: A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
- [7] Technological Characteristics:
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 5250-0 |
| Physical Properties | Meets ASTM D 5250-0 |
| Freedom from Holes | Meets ASTM D 5250-0 |
| Powder-Free | Meets ASTM D 5250-0 |
75 EAST WACKER DRIVE, SUITE 500 · CHICAGO, ILLINOIS · 60601 PHONE 312.337.7007 · FACSIMILE 312.337.0505
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1
Biocompatibility:
Primary Skin Irritation in Rabbits Repeated Patch Dermal Sensitization Test (Buehler) Passes Passoc
Substantial Equivalence: Both in its intended use and/or physical characteristics, this device is equivalent to legally marketed vinyl powder-free gloves. Except for a plastisol ingredient, this device is substantially equivalent to legally marketed vinyl powder-free gloves.
- [8] Performance Data: Leaching and biocompatibility comparative studies between this device and legally marketed powder-free gloves demonstrate that this device is substantially equivalent to legally marketed vinyl powder-free gloves.
- (છે] Clinical data not required.
- [10] (Multiple labels) Powder-Free Vinyl Examination Gloves meet or exceed the ASTM standard. (Multiple labels) Powder-Free Vinyl Examination Gloves meet labeling claims and pinhole AQL from the Freedom from Holes data in [7] above.
- This summary will include any other standards, special controls, labeling, or regulatory [1] information reasonably deemed necessary by the FDA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
DEC 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael D. Lelah, Ph.D. Managing Director, gloves Bernard Technologies, Incorporation 75 East Wacker Drive Chicago, Illinois 60601
Re: K033229
Trade/Device Name: (Multiple Labels) Powder- Free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 1, 2003 Received: October 6, 2003
Dear Mr. Lelah;
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. Lelah
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
Quls
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
ಲ್ಲ
4
K033229
3.0 Indications for Use Statement:
INDICATIONS FOR USE
Applicant: Bernàrd Technologies, Inc.
510(k) Number: N.A.
Device Name: (Multiple labels) Powder-Free Vinyl Examination Gloves
Indications for Use: A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ._
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ✓ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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