(36 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES are explicitly stated by referencing industry standards. The device's performance is reported as meeting these standards.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Material Specifications: | |
| ASTM Specification D 3578-99 Standard Specification for Rubber Examination Gloves | Gloves meet all current specifications listed under ASTM Specification D 3578-99. |
| Biocompatibility: | |
| Primary skin irritation testing (rabbit) | No irritation. |
| Delayed contact sensitization testing (guinea pig) | No sensitization. |
| Presence of Starch: | |
| USP iodine test for starch presence | Negative for the test. |
| Protein Content: | |
| 50 microgram or less of total water extractable protein per gram (as per 510(k) confirmation letter) | Contains 50 microgram or less of total water extractable protein per gram. |
| General Controls Provisions (as per FDA letter): | Compliance with annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for tensile strength, or how many rabbits/guinea pigs were used for biocompatibility). However, it implies that the testing was performed "as per ASTM D 3578-99 and 21 CFR 800.20," meaning the sample sizes and testing methodologies would follow those standards.
- Data Provenance: The tests are non-clinical (laboratory and animal data). The country of origin for the data is not specified, but the submission is to the FDA in the USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the evaluation of this device. The "ground truth" for glove performance is established by standardized testing protocols (ASTM D 3578-99) and regulatory requirements (21 CFR 800.20). Expert interpretation of images or clinical outcomes, which typically requires multiple experts and their qualifications, is not relevant for this product.
4. Adjudication Method for the Test Set
Not applicable. The tests involve quantifiable measurements against established standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device clearance for examination gloves. MRMC studies are typically performed for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. This type of study is not relevant for examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device. Performance tests were conducted on the physical product.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements.
- Industry Standards: ASTM Specification D 3578-99 for physical properties (e.g., dimensions, physical integrity, tensile strength) which dictate acceptable ranges for these characteristics.
- Regulatory Standards: 21 CFR 800.20 for biological safety (biocompatibility).
- Specific Claims: The claim of "50 microgram or less of total water extractable protein per gram" is also a specific performance metric.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is evaluated through direct physical and biological testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
{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 LATEXEXAMINATION GLOVES |
| Common Name | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed : | Ambiderm Powder Free Latex ExaminationGloves as described in the 510(k) notification aresubstantially equivalent to the Class 1 patientexamination glove 80LYY. It meets all thecurrent spec listed under the ASTM SpecificationD 3578 - 99 Standard Specification for RubberExamination Gloves. |
.
{1}------------------------------------------------
、・
| Description of the Device : | Ambiderm Powder Free Latex ExaminationGloves meet the current specifications listedunder the ASTM Specification D 3578 - 99Standard Specification for Rubber ExaminationGloves. They are either Violet, Blue, Green orPink colour. |
|---|---|
| Intended Use of the Device: | Ambiderm Powder Free Latex ExaminationGloves are intended for single use for medicalpurposes and are worn on the hand of health careand similar personnel to prevent contaminationbetween the health care personnel and thepatients. |
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice : | There are no different technologicalcharacteristics. Gloves are made from naturalrubber compound and the initial products arepowder free latex examination gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-99and 21 CFR 800.20. Gloves meet all the currentspecifications listed under the ASTMSpecification D 3578 - 99 Standard Specificationfor Latex Examination Gloves.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in the guineapig indicate no irritation or sensitization.Final product is negative for the test for presenceof starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn for the Nonclinicaland Clinical Tests : | Nonclinical laboratory and animal data indicatethat the pre - powdered natural product meets allperformance and biocompatability requirements. |
:
{2}------------------------------------------------
:
| Other Information Deemed Necessary by FDA : | Not applicable |
|---|---|
| --------------------------------------------- | ---------------- |
:
: :
;
,
,
.
.
!!
{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
.
§ 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.