(87 days)
K 011198
Not Found
No
The 510(k) summary describes a standard medical examination glove and does not mention any AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is an examination glove, which is intended to prevent contamination between a patient and examiner, not to treat a condition.
No
This device is a patient examination glove, which is a barrier device intended to prevent contamination. It does not perform any diagnostic functions like detecting, monitoring, or predicting a medical condition or disease.
No
The device is a physical examination glove made of polyurethane, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
The device is a medical examination glove, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
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)
The results of the safety, efficacy and performance testing of the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove are summarized as follows:
- The gloves meet all ASTM D 3578-01a requirements for freedom from holes, physical properties and physical dimensions, except ultimate elongation before aging. They meet the same requirements as the gloves cleared under K011198.
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO 10993-Part 10.
- The gloves meet requirements of ASTM-6124-01 for labeling as powder free. No powders are utilized in the manufacturer of this glove.
- The glove is manufactured using the same polymer materials as described in K011198.
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.
K 011198
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Maxxim Medical. The logo is in black and white and features the word "MAXXIM" in large, bold letters. Below the word "MAXXIM" is the word "MEDICAL" in smaller letters. The logo is simple and modern.
510(K) Submission: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/ Dental Examination Glove
AUG 01 2002
Attachment 4
Summary of Safety and Effectiveness
Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove
| Classification: | Class 1 |
|---|---|
| Panel: | Classification by the General Hospital and Personal Use Device |
| Common Name: | Medical Examination Gloves |
| Dental Examination Gloves | |
| Classification Name: | Patient Examination Glove (21 CFR 880.6250) |
The purpose of this 510(k) is to obtain an FDA clearance for manufacturing, importing and distributing a sterile, powder-free, polyurethane examination glove. The Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove is substantially equivalent to the SensiCare™ Advantix™ Medical/Dental Examination Glove, originally cleared under K 011198.
The results of the safety, efficacy and performance testing of the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove are submitted in this 510(k) application and are summarized as follows:
- The gloves meet all ASTM D 3578-01a requirements for freedom from holes, physical 1 . properties and physical dimensions, except ultimate elongation before aging. They meet the same requirements as the gloves cleared under K011198.
-
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO 10993-Part 10.
-
- The gloves meet requirements of ASTM-6124-01 for labeling as powder free. No powders are utilized in the manufacturer of this glove.
- The glove is manufactured using the same polymer materials as described in K011198. 4.
The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices.
There are no adverse changes to the safety and efficacy of the glove products in this submission. The only difference in the proposed glove will be the addition of the sterilization process and the change in packaging (single, pair vs. 100 count/box). Each product will be manufactured to the specifications and per documented label claims in K011198.
Signature of Certifier
4/30/02
Date
Julio Gonzalez Typed Name
4750 118th Avenue North · Clearwater, FL 33762
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Julio Gonzalez Director Quality Assurance Maxxim Medical 4750 118" Avenue North Clearwater, Florida 33762
Re: K021452
Trade/Device Name: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 30, 2002 Received: July 3, 2002
Dear Mr. Gonzalez:
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 vour 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.
2
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 (OS) 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
3
510(K) Submission: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove
Indications for Use
| Applicant: | Maxxim Medical, Inc. |
|---|---|
| 510(k) Number (if known): | K021452 |
| Device Name: | Sterile SensiCare® Advantix™ Powder Free Polyurethane |
| Medical/Dental Examination Glove | |
| Indications for Use: | A patient examination glove is a disposable device intended |
| for medical purposes that is worn on the examiner's hand to | |
| prevent contamination between patient and examiner. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
.
OR
Over-the-Counter Use
(Optional Format 1-2-96)
4750 118th Avenue North . Clearwater, FL 33762
Quta Sahn
Page 6
| vision Sign-Off) | |
|---|---|
| vision of Dental, Infection Control, | |
| General Hospital Devices | |
| 510(k) Number | K021452 |