(26 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device, POWDERED LATEX EXAM GLOVES, is described as a barrier to prevent contamination between patient and examiner. Its intended use focuses on protection and hygiene, not on diagnosing medical conditions or diseases.
No
The device is a physical medical device (patient examination gloves) and does not involve any software component.
Based on the provided information, 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 during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description "POWDERED LATEX EXAM GLOVES" further reinforces its nature as a physical barrier.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro analysis.
- Performance Studies: The listed performance studies (ASTM standards, Bio-Compatibility tests) are related to the physical properties, safety, and barrier function of the glove, not diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
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
POWDERED LATEX EXAM GLOVES, WITH PROTEIN LABELING (200 ug/g or less)
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 5712-99 ASTM D 3578-01 ASTM D 6124-99 ASTM D 5151-99 ISO 2859 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
AUG 2 6 2002
510(k) SUMMARY
| Submitted For: | HYCARE INTERNATIONAL CO., LTD.
457/2 Moo 3, Airport Road, Hat-Yai
Songkhla, 90110, Thailand |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES
Official Correspondent for Hycare International 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 July 2002 |
| Device Name: | POWDERED LATEX EXAM GLOVES,
WITH PROTEIN LABELING (200 ug/g or less)
Class I Device, 80LYY |
| Proprietary Name: | (Multiple Labels) Powdered Latex Exam Gloves,
With Protein Labeling (200 ug/g or less) |
| 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. It is Substantially
Equivalent to the devices manufactured by Premier
Pathway K001327, and SGMP Company Ltd. K000390. |
EXHIBIT K
Page 39 of 40
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 5712-99 ASTM D 3578-01 ASTM D 6124-99 ASTM D 5151-99 ISO 2859
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices approved as K001327 and K000390.
EXHIBIT K
Page 40 of 40
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 2002
Hycare International Company, Limited C/O Ms. Janna P. Tucker Official Correspondent for Hycare International Company, Limited Tucker and Associates 198 Avenue De La D' emerald Sparks. Nevada 89434-9550
Re: K022530
Trade/Device Name: Powdered Latex Exam Gloves with Protein Labeling 200 Microgram or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 29, 2002 Received: July 31, 2002
Dear Ms. Tucker:
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.
3
Page 2 - Ms. Tucker
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. 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,
Timothy A. Ulatowski
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
4
INDICATIONS FOR USE
| APPLICANT: | HYCARE INTERNATIONAL, CO., LTD |
|---|---|
| 510(k) NUMBER: | K022530 |
| DEVICE NAME: | POWDERED LATEX EXAM GLOVES, |
| WITH PROTEIN LABELING (200 ug/g or less) of Total Water Extractable Protein per gram |
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)
Prescription Use (Per 21 CFR 801.109)
EXHIBIT B
Page 2 of 40
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Olin S. Lim
(Division Sign-Off) on Sion Sign-Olf)
Division of Anesthesiology, General He Infection of Anesthesiology
Infection Control, Dental L
510(k) Number: 2