(62 days)
AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim 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.
Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are black in color.
The provided text describes the 510(k) summary for "AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS". This document focuses on the regulatory clearance for general-purpose medical gloves and does not involve AI, image analysis, or complex medical diagnostic performance. Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in the context of this medical device.
However, I can extract the relevant information regarding acceptance criteria and the methods used to demonstrate compliance for these examination gloves.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D 3578-99 (Standard Specification for Rubber Examination Gloves) | Meets all current specifications listed under ASTM D 3578-99 |
| 21 CFR 800.20 (Puncture Resistance, Force at Break, etc.) | Testing performed as per 21 CFR 800.20. Gloves meet all current specifications. |
| Primary Skin Irritation (rabbit) | No irritation indicated |
| Delayed Contact Sensitization (guinea pig) | No sensitization indicated |
| Test for Presence of Starch (USP iodine test) | Negative for the test |
| Protein Claims (50 micrograms or less per gram) | Meets the current specifications for protein claims |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for testing according to ASTM D 3578-99 or 21 CFR 800.20 for the specific device being submitted. These standards typically define sampling plans. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to U.S. regulatory standards (ASTM and FDA). The implication is that these were non-clinical, лабораторные испытания directly related to the product being submitted. It's a "prospective" evaluation in the sense that the new device was manufactured and then tested to meet established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This concept is not applicable here. "Ground truth" in this context refers to the defined specifications and performance requirements set by the ASTM standard and FDA regulations. The "experts" are the consensus bodies that established these standards, and the testing laboratories or personnel simply verify compliance against these objective metrics. There isn't an "expert adjudication" process like there would be for diagnostic imaging.
4. Adjudication Method for the Test Set:
Not applicable. Compliance is determined by direct measurement against objective criteria defined in the ASTM standards and FDA regulations, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This device is an examination glove, not an AI or diagnostic imaging device that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is not an algorithm. Its performance is evaluated through physical and material property testing.
7. The Type of Ground Truth Used:
The ground truth used is based on:
- Standard Specifications: ASTM D 3578-99 (physical properties like dimensions, tensile strength, elongation, freedom from holes).
- Regulatory Requirements: 21 CFR 800.20 (biocompatibility, protein claims).
- Laboratory Tests: Primary skin irritation in rabbits, delayed contact sensitization in guinea pigs, USP iodine test for starch presence.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (gloves), not an AI algorithm requiring a training set.
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}------------------------------------------------
510(K) SUMMARY
AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS
Submitter's Name:
MEDTEXX PARTNERS INC.
Submitter's Address:
Name of Contact Person:
Date of Preparation:
Name of Device:
Trade Name:
Common Name: Classification Name:
Legally Marketed Device to Which Equivalency is Being Claimed:
December 6, 1999
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAM
Latex Examination Gloves Patient Examination Gloves
Ambiderm Powder Free Latex Examination Gloves as described in the 510(k) notification are substantially equivalent to the class I patient examination glove 80LYY. It meets all the current spec listed under the ASTM specification D 3578-99 standard specification for rubber examination gloves.
Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are black in color.
Description of the Device:
{1}------------------------------------------------
Intended Use of the Device:
Summary of Technological Characteristics Compared to the Predicate Device:
Brief Discussion of Nonclinical Tests:
Brief Discussion of Clinical Tests:
Conclusions Drawn for the Nonclinical and Clinical Tests:
Other information Deemed Necessary by FDA:
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 patient.
There are no different technological characteristics. Gloves are made from natural rubber compound and the initial products are powder free latex examination gloves.
Testing is performed as per ASTM D 3578-99 and 21 CFR 800.20. Gloves meet all the current specifications listed under the ASTM specifications 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.
No new clinical test were conducted under this 510(K)
Nonclinical laboratory and animal data indicate that the prepowdered natural product meets all performance and biocompatibility requirements.
Not Applicable
{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Medtexx Partners, Incorporated c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114
K994131 Re : AMBIDERM Powder Free Latex Examination Trade Name: Gloves (Black Colored), with Protein Claims of 50 Micrograms or Less Per Gram Requlatory Class: I Product Code: LYY November 30, 1999 Dated: December 7, 1999 Received:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. प्र 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 Register. Please note: this response to your premarket notification submission does not affect any
{3}------------------------------------------------
Page 2 - Mr. Smith
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 regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debting 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 ene regulacion chorolor (112FR 807.97). 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known):
Device Name: AMBIDERM Powder Free Latex Examination Gloves (Black Colored), with Protein Claims of 50 Micrograms or Less Per Gram.
Classification Panel: 80LYY
Indications for Use:
AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim 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
or
Over-the-Counter Use
Clim Silim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospița 510(k) Number .
§ 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.