(124 days)
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Not Found
No
The device is a medical glove and the summary provides no indication of AI/ML technology.
No.
The intended use of the device is to prevent contamination, not to provide therapy or treatment for a condition.
No
The device, Nitra-Touch™ examination gloves, is intended to prevent contamination between patient and examiner and does not perform any diagnostic function.
No
The device is described as examination gloves, which are a physical product, not software. The summary focuses on material properties and performance tests related to the physical glove.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prevent contamination between patient and examiner" by being worn on the hand. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as "examination gloves."
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition. The performance metrics are related to the physical properties and barrier function of the glove.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Product codes
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Device Description
Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with the following variation. Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves except for the ultimate elongation percentage before and after aging.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
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Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The performance test data of the non clinical tests are the same as mentioned immediately above.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows a blurry black and white image. The image is mostly white, with some black lines and shapes. The black lines and shapes are concentrated in the center of the image. The image is not very clear, and it is difficult to make out any specific details.
nta. Georgia 30350
Telephone:
(770) 641-1900
Ansell Edmont Industrial Inc.
FAX: (770) 641-1988
K965055 Nitra-Touch
Checklist Section 21.0
- 510 (k) Summary [1]
- [2] Ansell Edmont Industrial, Inc. 400 Northridge Road. Suite 800 Atlanta, GA 30350
Telephone: 770-641-1900 Fax: 770-641-1988
Contact: Mike W. Hagans 614-623-3595 Telephone: Fax: 614-623-3515
December 12, 1996
- [3] Nitra-Touch™ Trade Name: Common Name: Exam Gloves Classification Name: Patient Examination Glove
- [4] Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with the following variation.
- (ર) Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves except for the ultimate elongation percentage before and after aging.
- [6] Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Nitra-Touch™ examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 |
| Except Ultimate Elongation meets | |
| specifications described under | |
| Attachment II | Original Ultimate Elongation 500% minimum |
| Aged Ultimate Elongation 400% minimum |
Revised 2/21/97
0
APR 22 1997
1
Image /page/1/Picture/0 description: The image shows the logo for Ansell Edmont Industrial. The words "Ansell Edmont" are stacked on top of each other in a bold, sans-serif font. Below the words "Ansell Edmont" is the word "Industrial" in a smaller, sans-serif font. The logo is simple and professional.
Ansell Edmont Industrial Inc.
400 Northridge Rd. Suite 800 Atlanta, Georgia 30350 Telephone: (770) 641-1900 FAX: (770) 641-1988
Nitra-Touch™
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Freedom from holes
Powder-Free Meets described test in Attachment V
Tensile Strength 60% higher than vinyl (synthetic) examination gloves
Puncture resistance of Nitra-Touch™ is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves
Nitrile film provides excellent chemical resistance to glutaraldehyde.
Meets ASTM D 3578 Meets ASTM D 5151
Not more than 2 mg residue by mass.
Tensile Strength MPa ASTM D 5250 ASTM D 3578 Vinyl = 10.5 Nitra-Touch™ = 17.1
Puncture Ibf/in ASTM D 120-87 Nitra-Touch™ = 1625 Blue Nitrile = 929 Vinyl (Synthetic) = 184
Glutaraldehyde Resistance ASTM T F739-91 Source: TRI/Environmental, Inc. Breakthrough Time = >480 Permeation Rate =