(169 days)
Not Found
No
The device is a simple examination glove and the description and testing focus on material properties and barrier function, with no mention of AI/ML.
No
A patient examination glove is intended to prevent contamination, not to treat or alleviate a medical condition.
No
This device, a latex exam glove, is intended to prevent contamination between patient and examiner, which is a protective function, not a diagnostic one. It does not analyze patient data or provide information for diagnosing a condition.
No
The device description clearly states it is a "Latex Exam Glove," which is a physical, disposable hardware device. The performance studies also focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination between the patient and examiner. Its purpose is a physical barrier, not to analyze biological samples.
- Intended Use: The intended use is for "medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic one.
- Lack of Diagnostic Elements: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic tests performed by the glove itself.
The testing mentioned (ASTM standards, protein content, water leak test, biocompatibility) are related to the physical properties, safety, and performance of the glove as a barrier device, not as a diagnostic tool.
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
LYY
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 dentists and doctor's 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
This device has met or exceeded the following standards/tests: ASTM D 3578-95, Standard Specification for Rubber Exam Gloves ASTM D 5712, RRIM Modified Lowry Microassay: Protein Content, mg/g (against BSA): Internal Surface: 11 +/- 4; External Surface: 12 +/- 4 FDA Water Leak Test AQL 4.0 Primary Skin Irritation Test Dermal Sensitization Study Biocompatibility [Repeated Insult Patch (200 Subjects)]
Key Metrics
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
MAR 1 3 1998
JANNA TUCKER & ASSOCIATES
973664 510(K) SUMMARY
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625- 391
Janna Tucker & Associates Submitted By: 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: 510-625-3908
Contact Person:
Date of Submission: August 19, 1997
Latex Exam Glove, Powder Free with Device Name: Protein and Hypoallergenic Labeling
Classification Name: Latex Exam Glove, 80LYY
(Various Labels) Latex Exam Glove, Powder Free, with Protein and Proprietary Name: Hypoallergenic Labeling
Janna P. Tucker, Official Correspondent of Evergrade
This device will be marketed to healthcare professionals at dentists Labels/Labeling: and doctor's offices, laboratories, clinics and hospitals through its intended use.
Healthcare Products SDN. BHD.
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:
The above device is equivalent to those in commercial distribution. These latex gloves are to be worn as a protective device on the examiners 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 by Sinochem Ningbo, K955918, Latex Exam Gloves, powder-free, with Protein Labeling and Hypoallergenic Claims.
EXHIBIT H
Page 45 of 46
1
Test Results (Means
and/or Results):
This device has met or exceeded the following standards/tests:
ASTM D 3578-95, Standard Specification for Rubber Exam Gloves ASTM D 5712, RRIM Modified Lowry Microassay: Protein Content, mg/g (against BSA): Internal Surface: 11 +/- 4; External Surface: 12 +/- 4 FDA Water Leak Test AQL 4.0 Primary Skin Irritation Test Dermal Sensitization Study Biocompatibility [Repeated Insult Patch (200 Subjects)]
Conclusions:
This device is substantially equivalent to the Sinochem Ningbo device approved under 510(k) K955918.
EXHIBIT M
Page 46 of 46
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Evergrade Healthcare Products Sdn Bhd C/O Janna Tucker & Associates 19001 S. Richfield #185 85614 Green Valley, Arizona
Re : K973664 Latex Examination Glove, Powder-Free, Trade Name: ade Name: (50 Micro grams or less) Requlatory Class: I Product Code: LYY February 4, 1998 Dated: February 10, 1998 Received:
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 regulations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts-800-to-895. A- ---------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.
3
Page 2 - Ms. Tucker
concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 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
Timoth Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
INDICATIONS FOR USE
| Applicant: | EVERGRADE HEALTHCARE PRODUCTS, SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K973664 |
| Device Name: | Latex Exam Glove, Powder Free, with Protein |
Indications For Use:
n and Hypoallergenic Labeling
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qiin S. him
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 46