(84 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 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 Violet, Blue, Green or Pink colored.
The provided text describes a 510(k) summary for AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES. This document is a regulatory filing for a medical device and, as such, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific performance criteria in the way a diagnostic algorithm or drug might.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of document. However, I can extract the relevant information where it exists and state explicitly when certain information is not provided.
Here is an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM D 3578-99 and 21 CFR 800.20) | Reported Device Performance |
|---|---|
| Physical Properties (per ASTM D 3578-99 standard) | "Gloves meet all the current specifications listed under the ASTM specifications D 3578-99 standard specification for latex examination gloves." (Specific metrics like tensile strength, elongation, dimensions, etc., are not detailed but are implied to be met by this statement.) |
| Freedom from Holes (AQL for pinholes, per ASTM D 3578-99 and 21 CFR 800.20) | Implied to be met by "Gloves meet all the current specifications listed under the ASTM specifications D 3578-99 standard specification for latex examination gloves" and regulatory compliance. (Specific AQL levels not stated) |
| Protein Content (specific to the protein claim) | "AMBIDERM Powder Free Latex Examination Gloves with Protein Labeling Claim... [with] Protein Claims of 50 Micrograms or Less Per Grams." |
| Biocompatibility - Primary Skin Irritation | "Primary skin irritation testing in the rabbit... indicate no irritation." |
| Biocompatibility - Delayed Contact Sensitization | "delayed contact sensitization testing in the guinea pig indicate no... sensitization." |
| Absence of Starch (USP Iodine test) | "Final product is negative for the test for presence of starch using the USP Iodine test." |
Note: The document states that the device is "substantially equivalent to the Class I patient examination glove 80LYY" and "meets all the current spec listed under the ASTM specification D 3578-99 standard specification for rubber examination gloves." This implies that the acceptance criteria are those defined in the ASTM standard and relevant FDA regulations for patient examination gloves. Specific numerical values for the performance criteria (e.g., tensile strength minimums, AQL levels) are not enumerated in this summary but would be detailed in the full ASTM standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "nonclinical tests."
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for these nonclinical tests is not specified beyond noting they were performed internally via ASTM D 3578-99 and 21 CFR 800.20 methodologies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards for physical properties, USP tests for chemical properties, animal models for biocompatibility), not by expert consensus on specific cases.
4. Adjudication Method for the Test Set
This concept is not applicable for the type of device and testing described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or diagnoses, not for performance testing of a physical product like an examination glove.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images) and assessing the impact of AI assistance. This device is a physical examination glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Test Specifications: Adherence to ASTM D 3578-99 for physical properties.
- Biocompatibility Testing: Results from established animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization).
- Chemical Tests: USP Iodine test for starch.
- Protein Content Measurement: Specific laboratory methods to quantify protein according to the stated claim (though the specific measurement method isn't detailed, it's implied by the protein claim).
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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510(K) SUMMARY
AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS
Submitter's Name:
LATEXX PARTNERS INC.
Submitter's Address:
Name of Contact Person:
Date of Preparation:
October 20, 1999
Name of Device:
Trade Name:
Common Name: Classification Name:
Legally Marketed Device to Which Equivalency is Being Claimed:
lly Marketed Device to W
ivalency is Being Claimed:
Description of the Device:
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 Violet, Blue, Green or Pink colored.
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| Intended Use of the Device: | Ambiderm Powder Free LatexExamination Gloves are intendedfor single use for medical purposesand are worn on the hand ofhealth care and similar personnelto prevent contamination betweenthe health care personnel and thepatient. |
|---|---|
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice: | There are no differenttechnological characteristics.Gloves are made from naturalrubber compound and the initialproducts are powder free latexexamination gloves. |
| Brief Discussion of Nonclinical Tests: | Testing is performed as per ASTMD 3578-99 and 21 CFR 800.20.Gloves meet all the currentspecifications listed under theASTM specifications D 3578-99standard specification for latexexamination gloves. |
| Primary skin irritation testing inthe rabbit and delayed contactsensitization testing in the guineapig indicate no irritation orsensitization. | |
| Final product is negative for thetest for presence of starch usingthe USP Iodine test. | |
| Brief Discussion of Clinical Tests: | No new clinical test wereconducted under this 510(K) |
| Conclusions Drawn for the Nonclinicaland Clinical Tests: | Nonclinical laboratory and animaldata indicate that the pre-powdered natural product meetsall performance andbiocompatibility requirements. |
| Other information Deemed Necessary byFDA: | Not Applicable |
:
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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" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2000 FEB
Latexx Partners, Inc. c/o Mr. E.J. Smith Latexx Partners, Inc. Smith Associates P.O. Box 4341 21114 Crofton, MD
Re : K993912 AMBIDERM Powder Free Latex Examination Trade Name: Gloves (Violet, Blue, Green and Pink), With Protein Content Labeling Claim (50 Micrograms Or Less) Regulatory Class: I Product Code: LYY November 1, 1999 Dated: Received: November 17, 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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Smith
the Federal Register. 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 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
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510(k) Number (if known):
Device Name: AMBIDERM Powder Free Latex Examination Gloves (Coloured), with Protein Claims of 50 Micrograms or Less Per Gram.
Classification Panel: 80LYY
Indications for Use:
AMBIDERM Powder Free Latex Examination Glove (coloured), 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)
or
Prescription Use
Over-the-Counter Use
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 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.