(26 days)
Not Found
No
The 510(k) summary describes a standard examination glove and makes no mention of AI or ML technology.
No.
The device (a patient examination glove) is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination between the patient and examiner. It does not collect or analyze data to provide diagnostic information.
No
The device is a physical examination glove, which is a hardware medical device, not 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 "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description confirms it's a glove made of latex.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro for diagnostic purposes.
IVD devices are specifically designed to be used in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not fit that definition.
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)
LYY
Device Description
Patient Examination Glove (Multiple Labels) Exam Gloves, Latex, Powder-Free, with Proprietary Name: Protein Labeling.
This device will be marketed to healthcare professionals at dentist, and doctor offices, laboratories, clinics and hospitals through its 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.
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/tests:
ASTM D ASTM D 3758-95
ASTM D 5151 FDA Water Leak Test (before & after aging) Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bacteria Mold
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
Image /page/0/Picture/0 description: The image shows the date July 12, 1999. The date is written in a simple, sans-serif font. To the left of the date is a small, stylized image of a flower or starburst. The image is black and white and appears to be a scan or photocopy.
JANNA TUCKER & ASSOCIATES
510(k) SUMMAR Y
RY
K992031
198 Avenue De La D'emerald Sparks, NV 89434-9550 Ph: 775-342-2612 Fax: 775-342-2613
| Submitted By: | Janna Tucker & Associates |
|---|---|
| 198 Avenue de la D'emerald | |
| Sparks, NV 89343 | |
| Phone: | 775-342-2612 |
| FAX: | 775-342-2613 |
Contact Person: Janna P. Tucker, Official Correspondent for Shanghai Changzheng Latex Factory
Date of Submission: 7 June 1999
Patient Examination Glove Device Name:
(Multiple Labels) Exam Gloves, Latex, Powder-Free, with Proprietary Name: Protein Labeling.
Labels/Labeling: This device will be marketed to healthcare professionals at dentist, and doctor offices, laboratories, clinics and hospitals through its intended use.
A patient examination glove is a disposable device intended for Intended Use: medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Substantial Equivalence:
This device is equivalent to those in commercial distribution. They are to be worn as a protective device on the examiner's hand or finger.
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured bv Evergrade Healthcare Products SDN BHD, K973664, Latex Examination Glove, Powder-Free, with Protein Content Labeling Claim.
IBIT M
47 of 48
1
Test Results (Means and/or Results):
This device has met or exceeded the following standards/tests:
ASTM D ASTM D 3758-95
ASTM D 5151 FDA Water Leak Test (before & after aging) Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bacteria Mold
Conclusions:
This device is substantially equivalent to the device approved as K973664.
EXHIBIT M
Page 48 of 48
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1.2 1999
Shanghai Changzheng Latex Factory c/o Janna Tucker & Associates Ms. Janna P. Tucker Official Correspondent 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550
Re : K992031 Trade Name: Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein) Requlatory Class: T Product Code: LYY Dated: June 14, 1999 Received: June 16, 1999
Dear Ms. Tucker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
3
Page 2 - Ms. Tucker
this response to your premarket notification Please note: submission does not affect any obligation you might have under bubmisbled. acob ough 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA ating of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markees problems, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation 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 ene regulation cherocod, "Alberting of "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ser
Timothy A
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Junier
Enclosure
4
INDICATIONS FOR USE
Nato APPLICANT દેશના
SHANGHAI CHANGZHENG LATEX FACTORY
210(K) NUMBER : 一年十六年
ಿ DEVICE NAME:
amination ( 685 WATER SOLUBLE PROTECT A
A patient examination glove is a disposable device intended for medical purposes that is
t and the country and and and assessed contemination between patient and A patient examination glove is a disposable device is as as as as as as a continue 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 X
(Optional Format 1-2-96)
Chin S. Lim
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992031
EXHIBIT B
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