(72 days)
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.
Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
Here's a summary of the acceptance criteria and study information for the Bernard Technologies, Inc. Powder-Free Vinyl Examination Gloves, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Physical Properties | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Freedom from Holes | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Powder-Free | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Biocompatibility | Pass Primary Skin Irritation | Passes |
| Pass Dermal Sensitization | Passes | |
| General Performance | Meet or exceed ASTM standard | Meets or exceeds ASTM standard |
| Labeling Claims | Meet labeling claims | Meets labeling claims |
| Pinhole AQL | Meet pinhole AQL from Freedom from Holes data | Meets pinhole AQL |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the testing of the "Powder-Free Vinyl Examination Gloves." It refers to meeting the requirements of ASTM standard D 5250-00, which would dictate standard testing methodologies and sample sizes for glove performance. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission, not from a clinical study. The tests would be prospective in nature, as they are performed on the device being submitted for clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a patient examination glove, and the "ground truth" for its performance is established by objective physical and chemical testing against established standards (ASTM D 5250-00) and biocompatibility tests, not subjective expert assessment as would be common for diagnostic imaging or clinical decision support AI devices.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is determined by objective testing against a standard, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. For examination gloves, the endpoints are primarily physical properties and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (glove), not an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance is based on established industry standards (ASTM D 5250-00) for dimensions, physical properties, freedom from holes, and powder-free status. Additionally, biocompatibility testing results (Primary Skin Irritation in Rabbits and Repeated Patch Dermal Sensitization Test) served as ground truth for biological safety.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI or algorithm that relies on a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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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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.
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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
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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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§ 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.