(36 days)
Not Found
Not Found
No
The device is a glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
Explanation: The device, examination gloves, is intended to prevent contamination between healthcare personnel and patients. It does not provide any therapeutic benefit or treatment.
No
Explanation: The device is described as examination gloves used to prevent contamination, not to diagnose medical conditions.
No
The device is described as "Powder Free Latex Examination Gloves," which are physical gloves made of latex. The description focuses on material specifications (ASTM D 3578-99) and physical properties, not software functionality.
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 gloves are for preventing contamination between healthcare personnel and patients. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on material specifications and color, not on any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties (meeting ASTM standards) and biocompatibility (skin irritation/sensitization), which are relevant for a barrier device, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This description does not align with that definition.
N/A
Intended Use / Indications for Use
AMBIDERM Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Ambiderm Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are either Violet, Blue, Green or Pink colour.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
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)
Brief Discussion of Nonclinical Tests : Testing is performed as per ASTM D 3578-99 and 21 CFR 800.20. Gloves meet all the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Latex Examination Gloves. Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization. Final product is negative for the test for presence of starch using the USP iodine test.
Brief Discussion of Clinical Tests : No new clinical tests were conducted under this 510(k).
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.
Not Found
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
OCT 20 1999
ﻨﻪ .
510(k) SUMMARY
Attachment 15
:
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES
ないということです
| Submitter's Name : | MEDTEXX PARTNERS INC. |
|---|---|
| Submitter's Address : | |
| Submitter's Phone Number | |
| Submitter 's Fax Number : | |
| Name of Contact Person : | |
| Date of Preparation : | July 9, 1999 |
| Name of Device : | |
| Trade Name : | AMBIDERM POWDER FREE LATEX |
| EXAMINATION GLOVES | |
| Common Name | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which | |
| Equivalency is Being Claimed : | Ambiderm Powder Free Latex Examination |
| Gloves as described in the 510(k) notification are | |
| substantially equivalent to the Class 1 patient | |
| examination glove 80LYY. It meets all the | |
| current spec listed under the ASTM Specification | |
| D 3578 - 99 Standard Specification for Rubber | |
| Examination Gloves. |
.
1
、・
| Description of the Device : | Ambiderm Powder Free Latex Examination
Gloves meet the current specifications listed
under the ASTM Specification D 3578 - 99
Standard Specification for Rubber Examination
Gloves. They are either Violet, Blue, Green or
Pink colour. |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device: | Ambiderm Powder Free Latex Examination
Gloves are intended for single use for medical
purposes and are worn on the hand of health care
and similar personnel to prevent contamination
between the health care personnel and the
patients. |
| Summary of Technological
Characteristics Compared to the Predicate
Device : | There are no different technological
characteristics. Gloves are made from natural
rubber compound and the initial products are
powder free latex examination gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-99
and 21 CFR 800.20. Gloves meet all the current
specifications listed under the ASTM
Specification D 3578 - 99 Standard Specification
for Latex Examination Gloves.
Primary skin irritation testing in the rabbit and
delayed contact sensitization testing in the guinea
pig indicate no irritation or sensitization.
Final product is negative for the test for presence
of starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this
510(k). |
| Conclusions Drawn for the Nonclinical
and Clinical Tests : | Nonclinical laboratory and animal data indicate
that the pre - powdered natural product meets all
performance and biocompatability requirements. |
:
2
:
| Other Information Deemed Necessary by FDA : | Not applicable |
|---|---|
| --------------------------------------------- | ---------------- |
:
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3
Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 1999
Medtexx Partners, Inc. c/o E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114
K993080 Re: AMBIDERM Latex Examination Gloves (Violet, Trade Name: Blue, Green, and Pink), containing 50 microgram or less of total water extractable protein per gram Class: I Product Code: LYY Dated: September 14, 1999 Received: September 14, 1999
Dear Mr. Smith:
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, Druq, 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 Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
4
Page 2 - Mr. Smith
the Federal Register. Please note: this response to your the reactal notification submission does not affect any obligation you might have under sections 531 through 542 of obilgation 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 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) 594-4692. 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" (21 CFR 807.97). Other general premation 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,
Timothy A. Ulatowski
hy A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known):
Device Name: AMBIDERM Powder Free Latex Examination Gloves (Contoured) Pink, Orolet , િરિય contains: 50 mig Water Extract able Profeit m Ci
Classification Panel: 80LYY
Indications for Use:
AMBIDERM Powder Free Latex Examination Glove (coloured) is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use or
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospițal D E 10(k) Number .
7
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