(43 days)
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No
The document describes a standard medical examination glove and makes no mention of AI or ML technology.
No
The device is described as an examination glove intended to provide a barrier against infectious materials and contaminants, not to treat or alleviate a disease or condition.
No
A medical examination glove is a barrier device for protection, not a device used to identify, measure, or monitor medical conditions or provide a diagnosis.
No
The device is a physical medical examination glove made of a synthetic polymer, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier function for the user, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the material (LYCRA® polymer), form (glove), and physical properties (ambidextrous, powder-free, sizes). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical examination glove, which is a Class I or Class II medical device used for protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
DuraCLEAN® with LYCRA® Medical Examination Glove is a disposable device made of synthetic LYCRA® polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is an ambidextrous, powder-free patient examination glove composed of 100% DuPont LYCRA® polymer. It is offered non-sterile, in a range of sizes from Extra Small to Extra Large.
The device meets the requirements of applicable recognized standards, including those specified by ASTM D3578, ASTM D6124, ASTM D5151, and the agency's June, 1999 draft Medical Glove Guidance Mamual.
The device has been demonstrated biocompatible through dermal irritation, dermal sensitization, and cytotoxicity testing in accordance with EN ISO 10993.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: In vivo and in vitro testing conducted to assess dermal irritation, dermal sensitization, and cytotoxicity, establish that the subject device is biocompatible within the limits of those test.
Clinical Tests: (Not applicable)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991615, K010297, K011198, K950033, K011482, K012048, K020317, K955464
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(k) Summary VII.
K@2205S
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted for
Wilshire Technologies, Inc. 5861 Edison Place Carlsbad, California 92008 Telephone: (760) 929-7200 Contact: Derek Warneke, Vice President of Operations and Technology Date Prepared: June , 2002
B. Device Name
| Trade or Proprietary Name: DuraCLEAN®with LYCRA® Medical
| Examination Glove | |
|---|---|
| Common or Usual Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove |
C. Predicate Devices
The subject device is substantially equivalent, in whole or in part, to predicate gloves manufactured by Maxxim Medical (K991615, K010297 and K011198), Wilshire Technologies (K950033), WRP Asia Pacific (K011482 and K012048), SGMP (K020317), and Tactyl Technologies (K955464).
D. Device Description
The subject device is an ambidextrous, powder-free patient examination glove composed of 100% DuPont LYCRA® polymer. It is offered non-sterile, in a range of sizes from Extra Small to Extra Large.
The device meets the requirements of applicable recognized standards, including those specified by ASTM D3578, ASTM D6124, ASTM D5151, and the agency's June, 1999 draft Medical Glove Guidance Mamual.
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The device has been demonstrated biocompatible through dermal irritation, dermal sensitization, and cytotoxicity testing in accordance with EN ISO 10993.
E. Intended Use
DuraCLEAN® with LYCRA® Medical Examination Glove is a disposable device made of synthetic LYCRA® polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.
F. Comparison to Predicate Devices
The subject device has the same, or equivalent, indications for use as do other powder-free patient examination gloves cleared for commercial distribution in the U.S.;
The subject device is offered non-sterile, and in a variety of sizes ranging from Extra Small to Extra Extra Large, as are other powder-free patient examination gloves cleared for commercial distribution in the U.S .;
The subject device has the same or equivalent composition as other powderfree examination gloves cleared for commercial distribution in the U.S .;
The subject device conforms to ASTM D3578 in terms of dimensions, physical properties before and after aging, and pinholes, as do other powderfree examination gloves cleared for commercial distribution in the U.S .;
The subject device conforms to ASTM D6124 in terms of weight of powderfree residue, as do other powder-free examination gloves cleared for commercial distribution in the U.S .; and
The subject device has been shown biocompatible through dermal irritation, dermal sensitization and cytotoxicity testing, as have other powder-free examination gloves cleared for commercial distribution in the U.S.
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G. Summary of Non-Clinical Tests
In vivo and in vitro testing conducted to assess dermal irritation, dermal sensitization, and cytotoxicity, establish that the subject device is biocompatible within the limits of those test.
H. Summary of Clinical Tests
(Not applicable)
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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 9 2002
Wilshire Technologies C/O Mr. Steve Reitzler Regulatory Agent 13221 Maricotte Place San Diego, California 92130
Re: K022095
Trade/Device Name: DuraCLEAN® with LYCRA® Powder Free Polyurethane Medical Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 24, 2002 Received: June 27, 2002
Dear Mr. Reitzler:
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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Reitzler
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski
Timothy A . Ulatowski 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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V. Draft Labeling
Indications for Use A.
| 510(k) Number (if known): | K 022095 |
|---|---|
| Powder Free Polyurethane | |
| Device Name: | DuraCLEAN ® with LYCRA ® Medical Examination Glove |
Indications for Use:
DuraCLEAN® with LYCRA® Medical Examination Glove is a disposable device made of synthetic LYCRA® polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K022095 |
|---|---|
| --------------- | --------- |