(129 days)
Not Found
No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No
The device is described as an examination glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to diagnose a condition or disease.
No
The device is a physical glove, not software. The description clearly states "Powdered Latex Examination Glove with Aloe Vera".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a glove, a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes
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)
Not Found
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
§ 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
| FEB 04 2002 | K013254
510(K) SUMMARY
(as required by 807.92(c)) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Top Quality Manufacturing
6800 Lindbergh Ave.
Philadelphia, PA 19142 |
| | Phone:
1-800-468-4886 |
| Contact Person: | Marc Sinkow |
| Date of Summary: | October 25, 2001 |
| Trade Name: | Powdered Latex Examination Glove with Aloe Vera |
| Classification Name: | Glove, Patient Examination, Poly |
| Predicate Device: | Top Quality Skingard Polycoat Gloves K004018 |
| Intended Use: | The Top Quality Skingard Polycoat Powdered Latex
Examination Glove with Aloe Vera is intended for medical
purposes to be worn on the examiner's hand or finger to
prevent contamination between patient and examiner |
Device Comparison:
| | Polycoat Glove with
Aloe Vera | Skingard Polycoat
Gloves |
|-------------------|----------------------------------|-----------------------------|
| 510(k) | | K004018 |
| Testing Completed | | |
| | ASTM D5712-95 | Same |
| | ASTM D3578-00 | Same |
| | ASTM D6124 | Same |
| Intended Use | Examination | Same |
| Glove | Latex | Same |
| Packaging | 100 | 100 |
| Glove Coating | Silicone | Silicone |
| Powdered | Yes | Yes |
| With Aloe Vera | Yes | No |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 0 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Top Quality Manufacturing, Incorporated C/O Mr. Arthur Ward Regulatory & Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K013254
Trade/Device Name: Polycoat Powdered Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (200 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 29, 2001 Received: November 14, 2001
Dear Mr. Ward:
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
2
Page 2 - Mr. Ward
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 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,
K. Allalutka
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K013254
Top Quality Manufacturing, Inc. - Polycoat Powdered Latex Examination Device Name: Glove with Aloe Vera + PROTEN CONTENT LABELING COMMICROGRAM OR W
Indications For Use:
The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be worn on the examiner's hand or finger 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
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic r Offer Namber
(Optional Format 1-2-96)