(71 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The intended use states the device is to prevent contamination between patient and examiner, which is a protective function, not a therapeutic one.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a physical glove, which is a hardware component. There is no mention of software.
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 or finger 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 is for "POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES." This is a physical barrier, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information
- Using reagents or assays
The purpose of this device is to provide a physical barrier to prevent the spread of contamination, which is a different function than an in vitro diagnostic device.
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 or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals at Dentist and Doctor Offices, Laboratories, Clinics and Hospitals
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)
This device has met or exceeded the following standards and/or tests:
ASTM D 3578-00
ASTM D 5712-00
ASTM D 6124-00
ASTM D 5151-00
ASTM F 1671
ASTM F 1383
ASTM F 903
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
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.
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
FEB 1 3 2002
510(k) SUMMARY
| Submitted For: | SHEEN MORE ENTERPRISE CO., LTD.
No. 16 Tou Kung Six Road
Tou-Liu Expanded Industrial Park
Tou-Liu City, Yun-Lin County
Taiwan R.O.C. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES
Official Correspondent for SHEEN MORE ENTERPRISE
CO., LTD.
JANNA P. TUCKER, President-CEO
198 Avenue de la D'emerald
Sparks, NV 89434-9550
Phone:
775-342-2612
Fax:
775-342-2613
E-Mail:
Tuckerjan(@aol.com |
| Date of Submission: | 29 November 2001 |
| Device Name: | POWDER-FREE LAVENDER/PURPLE NITRILE
EXAM GLOVES, Class I Device, 80LZA |
| Proprietary Name: | (Multiple Labels) Powder-Free Lavender/Purple Nitrile
Exam Gloves. |
| Labels/Labeling: | This device will be marketed to healthcare professionals at
Dentist and Doctor Offices, Laboratories, Clinics and
Hospitals through its distributors for the intended use. |
| Intended Use: | A 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. |
| Substantial Equivalence: | Both in its intended use and/or physical
characteristics, this device is equivalent to devices
currently marketed by U.S. companies. Except for color, it
is substantially Equivalent to the device manufactured by
Sinochem Ningbo Latex Glove Factory's K980802 glove
and Ningbo Yujiang's Lavender/Purple Nitrile Glove
(K003563). |
EXHIBIT M
Page 48 of 49
1
510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 3578-00 ASTM D 5712-00 ASTM D 6124-00 ASTM D 5151-00 ASTM F 1671 ASTM F 1383 ASTM F 903 Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices Approved as K980802 and K003563.
EXHIBIT M
page 49 of 49
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized birds in flight, stacked on top of each other. The logo is in black and white.
Public Health Service
FEB 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sheen More Enterprise Company Limited C/O Janna P. Tucker Consultant Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550
Re: K013998
Ro13770
Trade/Device Name: Powder-Free Lavender/Purple Nitrile Exam Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: November 29, 2001 Received: December 4, 2001
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases one the device is substantially equivalent (for the itelered above and have economissore) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to may as, as, reclassified in accordance with the provisions of Antendinents, or to devices and have of the Act (Act) that do not require approval of a premarket the redelar Pood, Drug, and Conneasy, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condons provisions of the stration, 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 IT your device is classinod (200 as of ditional controls. Existing major regulations affecting (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvrasod that 1 Dr. determination that your device complies with other requirements
3
Page 2 - Ms. Tucker
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouctures and securements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT rat 807), adolity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are quadiation 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 110(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 If you desire pochio as a rart 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Comphance wee, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under nother for OF CF ICP of the Division of Small Manufacturers, International and the receiner of over 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 Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE
APPLICANT:
SHEEN MORE ENTERPRISE CO., LTD.
510(k) NUMBER:
KO1 3998
POWDER-FREE LAVENDER/PURPLE DEVICE NAME: NITRILE EXAM GLOVES
A patient examination glove is a disposable device intended for medical purposes that is I pations chammanen grow of inger 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)
Chis S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev Fifth Number _
EXHIBIT B
Page 2 of 49